Ketoprofen gel as an adjunct to physical therapist management of a child with sever disease.

Calcaneal apophysitis was first described by Sever in 1912 and later was named after him. Sever described a painful condition of the heel that occurs only in children and never after puberty. (1) The condition is an overuse syndrome, analogous to Osgood-Schlatter disease, (2) and is defined as an inflammatory condition. (3) The calcaneal apophysis is the point at which the Achilles tendon inserts on the calcaneus. Apophyses consist of columns of cartilage and are secondary centers of ossification. Apophysitis results from repetitive microtrauma, which causes microavulsions, at the bone-cartilage junction, (4) and it occurs when the repetitive injuries outpace the ability of the bone to heal. (5) Calcaneal apophysitis is the most common cause of heel pain in athletic children, typically occurring during a growth spurt and at the beginning of a new sport season. (2) The condition has been reported to have an incidence rate of 5.8% of all injuries to athletes under 20 years of age. (3) Sports most commonly associated with Sever disease involve running and jumping, with soccer being one of the sports that most commonly exacerbates the symptoms. (6)

A child with Sever disease usually reports nonradiating pain in the posterior calcaneus with weight-bearing activities, and the pain is relieved by rest. The pain is usually accompanied by decreased flexibility of the Achilles tendon, resulting in diminished dorsiflexion to 10 degrees or less. (1,2,5-7) The onset of pain is gradual and can become severe enough to prevent participation in physical activities. (3) In growing children, long bone growth in the lower extremity often exceeds muscle and tendon growth resulting in decreased dorsiflexion range of motion (ROM). (6,8) The imbalance may contribute to increased tensile stress on the calcaneal apophysis with weight-bearing activities. (6) Sever disease cannot be diagnosed radiographically, but radiographs are used to rule out other potential pathologies resulting in heel pain. (6)

The use of heel lifts in the treatment of patients with Sever disease has been well documented, dating back to 1912 by Sever himself. Sever recommended the use of 1/4to 1/2-inch heel lifts to relieve tension on the calcaneus by a tight Achilles tendon and to reduce the amount of weight bearing on the heel. (1) The use of heel lifts has continued to be a standard component of intervention for patients with Sever disease. (2,4-7,9) MacLellan and Vyvyan (10) documented the reduced ground reaction force transferred to the heel on heel strike and a reduction in (unspecified) heel pain through the use of viscoelastic heel inserts. Furthermore, Madden and Mellion (6) recommended the use heel lifts or viscoelastic heel cups to reduce impact shock in the treatment of patients with Sever disease. In more resistant or severe cases, oral nonsteroidal anti-inflammatory drugs (NSAIDs) may be used, or a short leg cast may be applied for 2 to 4 weeks. (6,7,9)

The desired outcome of physical therapy for a patient with Sever disease is the patient's return to participation in all physical activities after the symptoms have resolved. For this to occur, the patient must be able to bear weight through the heel without pain. Once the patient is no longer experiencing pain, a gradual return to activities can be undertaken. The secondary ossification center of the calcaneus is active between 7 and 16 years of age. (2) Sever disease, therefore, is self-limiting; once the apophysis has ossified, the condition can no longer occur. Sever disease usually occurs between 8 and 10 years of age in females and between 10 and 12 years of age in males. (6) No long-term problems have been documented in the medical literature as a result of Sever disease (7); however, the condition is painful and can limit activities. The self-limiting nature of the condition means an excellent prognosis for full recovery, including a return to full activities. The potential of reinjury due to increased intensity of activity, changes in physical activities, decreased extensibility of the Achilles tendon, or a growth spurt remain a continued concern. (1,6) Care and preventative measures (including stretching, strengthening, icing, and use of proper footwear) should be taken to avoid a relapse and future aggravation of the condition.

Medications that provide anti-inflammatory and analgesic effects may be a component of the treatment regimen for patients with Sever disease (3,5-7,9); however, the treatment of a child using a steroidal anti-inflammatory medication must be undertaken with considerable caution. (9) Steroids, including topical steroids administered by iontophoresis, have the potential to cause adverse systemic and local effects. (11) The possibility of adverse effects in children is greater than in adults, with growth retardation and suppression of the pituitary-adrenal axis (causing iatrogenic Cushing syndrome) being particular concerns. (11) Local adverse effects include atrophy, steroid rosacea, allergic contact dermatitis, and persistent erythema. (11) Nonsteroidal anti-inflammatory drugs, including transdermal NSAIDs, can be used as an alternative to obtain local anti-inflammatory and analgesic activity in diseases of the musculoskeletal system. (12) The 3 main actions of NSAIDs are anti-inflammatory, analgesic, and antipyretic. The primary mechanism of action for all 3 actions is a decrease in the production of prostaglandins; the anti-inflammatory and analgesic actions are achieved through the inhibition of arachidonic acid cyclooxygenase. (13) However, the antiinflammatory action itself is achieved by a decrease in vasodilatation, whereas analgesic action is achieved by decreased sensitization of nociceptive nerve endings. (13)

A transdermal delivery system for NSAIDs has several benefits compared with the use of oral NSAIDs. One advantage is the achievement of a therapeutically effective local concentration of the medication with as low a plasma concentration as possible in an attempt to avoid the potential adverse effects of systemic absorption. (12,14-17) The stomach is avoided with the use of a transdermal delivery system, eliminating the first-pass effect and metabolization of the drug by the liver, minimizing the adverse gastrointestinal effects associated with oral NSAIDs. (14) Transdermal NSAIDs have been shown to have a much lower incidence of adverse gastrointestinal effects compared with the same drugs when taken orally. (18) In a review of the literature, Vaile and Davis (19) concluded that a sufficient number of studies have demonstrated the superiority of topical NSAIDs over placebo and suggested efficacy equivalent to that of oral NSAIDs. In a systematic review of topically applied NSAIDs, Moore et al (18) determined that no study up to that time had shown a significant benefit of oral preparations over topical preparations of the same drug used to treat the same condition.

Ketoprofen concentrations in tissues local to the site of transdermal application have been shown to be substantially higher than plasma concentrations. (12, 15-17) The differences in tissue concentration compared with plasma levels have been demonstrated through biopsies of synovial fluid and tissue, capsular tissue, cartilage, skin, tendon, tendon sheath, and adipose tissue near the site of application. The samples were analyzed for ketoprofen concentration and then compared with blood samples taken from the patient at the time of tissue reoverv. (12,15-17) The use of phonophoresis, although confirmed as an effective method for the delivery of ketoprofen in high local tissue concentrations, (17) is contraindicated for children because ultrasound is a potentially dangerous modality if applied over an epiphyseal plate due to its effects on cellular tissues. (20)

A review of the available literature identified no information on the use of transdermal NSAIDs in the treatment of patients with Sever disease or any other apophysitis. Several studies have confirmed the efficacy of transdermal ketoprofen in the treatment of other conditions in humans. Cannavino et al (4) reported the effectiveness of transdermal ketoprofen for the reduction of delayed-onset muscle soreness after the completion of a double blind, placebo-controlled clinical trial. Patel and Leswell (21) performed an open-label, comparative, parallel-group, multicenter, general practice study to compare the efficacy, tolerability, and acceptability of transdermal ketoprofen gel with piroxicam gel and diclofenac gel in patients with acute soft tissue injury. The study showed the beneficial effects of ketoprofen to be statistically significant compared with piroxicam, and ketoprofen compared favorably with diclofenac, based on reports of patients. The researchers concluded that ketoprofen gel showed excellent tolerability and benefits over established methods of treatment for acute soft tissue injury. (21) Ketoprofen has been demonstrated to have no deleterious effects on cartilage, (22-24) and potentially deleterious effects of NSAIDs on cartilage have been diminished with the use of transdermal ketoprofen as a result of the drug's short half-life. (15)

In 1998, Moore et al (18) performed a meta-analysis of 86 clinical trails of topically applied NSAIDs, involving 10,160 patients. The authors sought randomized controlled trails of transdermal NSAIDs with pain as an outcome and included the comparisons of transdermal NSAIDs with another transdermal NSAID, oral NSAIDs, and placebo. The authors concluded that transdermal NSAIDs were effective in relieving acute and chronic pain, and ketoprofen was effective in the treatment of both acute and chronic conditions with very low incidence of adverse local and systemic effects. They found no difference in the adverse effects of the transdermal NSAIDs and placebo. (18)

A literature review yielded no data on the use of transdermal ketoprofen in the pediatric population. The purpose of this case report is to describe the combination of traditional methods of treatment for a patient with Sever disease with the transdermal delivery of ketoprofen.

Case Description

History

The patient was an 8-year-old girl with no significant medical history prior to the onset of pain in the right posterior calcaneus. Symptoms had been present intermittently for the past 1 1/2 to 2 years, but had not previously attained a debilitating level. The severity of the patient's pain prompted the patient's mother to seek medical attention.

The medical diagnosis for the patient was Sever disease of the right calcaneus. Radiographs of the right calcaneus determined that calcaneal growth and development were within the normal range. The physician referred the patient for physical therapy for 2 visits per week for 3 weeks. The referral was for physical therapist evaluation and treatment, including iontophoresis. The physician ordered the cessation of all athletic activities, including physical education class at school, until she was advised to resume them. The physician instructed the mother to give the patient Children's Motrin * as needed and referred her to a local shoe store for heel lifts.

The patient and her mother described the pain as debilitating, not radiating, and located at the posterior portion of the calcaneus. The heel pain prevented participation in activities beginning 3 weeks prior to the initial physical therapist examination. This was the patient's first episode of physical therapy for Sever disease.

Initial Examination

The initial physical therapist examination and evaluation were conducted 4 days following the patient's initial visit to the physician. On a 0-to-10 numerical rating scale (NRS) for pain (0 being "no pain" and 10 being "the worst pain imaginable"), the patient rated the pain to be a constant 8/10 with weight bearing (Tab. 1). She reported that sitting, resting, taking weight off her feet, and icing relieved the pain, with a pain rating of 0/10. Activities that aggravated the patient's pain most were ballet, soccer, running, and jumping. The patient reported that walking for 10 minutes, standing for up to 1 hour, and walking up and down stairs aggravated the pain to unbearable levels. She last participated in ballet 3 weeks prior to the initial physical therapist examination. Motrin had been used sparingly, because of her mother's expressed preference to administer oral medications only if absolutely necessary.

The test-retest reliability for the NRS for pain has been estimated to be .947 to .963 as determined with a Pearson product moment correlation in a study of 91 patients with rheumatoid arthritis. (25) Test-retest reliability of visual analog scale (VAS) scores has been estimated to be .78 in a study of 40 patients with cancer. (26) Numerical rating scale scores were found to correlate with VAS pain scores in a study of 50 patients with cancer, aged 19 to 76 years (Spearman correlation coefficient=.847). (27) In a study of 18 patients with knee disorders, aged 20 to 50 years, construct validity of VAS scores was demonstrated using a repeated-measures analysis of variance (F=19.72; df=2,20, P<.001) and a Newman-Keuls post hoc test (P<.01). (28) Pain rating prior to the beginning and at the conclusion of several weeks (an average of 11 weeks) of physical therapy intervention were used for the determination of statistically significant clinical change. (28) Paice and Cohen (27) asserted, based on research demonstrating the VAS to be a valid measure of pain intensity and the statistically significant correlation between NRS and VAS scores, that construct validity of NRS scores as a measure of pain intensity also is supported. Furthermore, several authors (25,27,29) have pointed out that the NRS is easier for patients to understand and to complete compared with the VAS.

Strength (the force-generating capacity of muscle) was assessed with gross manual muscle testing (MMT) and graded on a 5-point scale (30); ROM was assessed through goniometric measurements and recorded in degrees. (31) Intrarater reliability of MMT scores (32) has been estimated in a study of 102 boys with Duchenne muscular dystrophy, aged 5 to 15 years, using weighted kappa statistics of .71 to .93 and an intraclass correlation coefficient (ICC) of .99 for the lower extremities. Intrarater reliability for passive ROM of the ankle has been estimated in a study of 43 subjects (50 feet) with neurological or orthopedic disorders, aged 12 to 81 years, with ICCs of .90 for dorsiflexion and .86 for plantar flexion. (31) Intrarater reliability for active ROM of the ankle was estimated in a study of 38 subjects (45 ankles) with orthopedic disorders, aged 13 to 71 years, with ICC results of .64 to .92 for active ROM in dorsiflexion and .47 to .96 for active ROM in plantar flexion. (33) In a study of 30 subjects who were healthy and aged 20 to 60 years, goniometric measurements of the lower extremities were correlated with roentgenograms to determine construct validity, using both Pearson product moment correlation coefficients (.97-.98) and ICCs (.98-.99). (34) The results demonstrated that the measurements taken with the goniometer reflected actual joint positions. (34) Right dorsiflexor and knee flexor strength were particularly diminished (Tab. 2). Active and passive ROM of the right ankle, measured with the knee in full extension, were diminished in all planes compared with the left ankle, particularly in dorsiflexion and eversion (Tab. 3). The patient's strength and ROM were within normal limits in the left lower extremity. Dorsiflexion active ROM in children, measured with the knee in full extension, should be at least 10 degrees, (35(p56)) and MMT for children follows the same grading scale as used with adults. (35(p17))

Palpation of the posterior calcanei at the insertion of the Achilles tendon bilaterally yielded tenderness (right greater than left). The calcaneal compression test (2,6,9) (reliability and validity were not reported) elicited pain in the right calcaneus, but not in the left calcaneus. The test is performed by squeezing the medial and lateral aspects of the lower one third of the posterior calcaneus together. (2,6,9) Achilles tendon reflexes were normal bilaterally, as were straight-leg-raise nerve tension tests. Mild puffiness was detected around both ankles. Palpation of the right popliteal fossa produced mild tenderness at the insertions of the hamstring muscles and the origins of gastrocnemius muscles, with no tenderness in the left lower extremity. Manual stretching of the hamstring and calf muscles showed decreased extensibility on the right compared with the left. No gait abnormalities were observed with barefoot gait, except mild bilateral forefoot pronation. The patient was able to perform bilateral single leg stance for more than 1 minute on a firm surface without shoes.

Evaluation, Diagnosis, and Prognosis

The patient had classic signs and symptoms of Sever disease, including pain in the heel that was aggravated by activity and relieved by rest, tenderness on the medial and lateral sides of the calcaneus with the calcaneal compression test, (1,2,9) forefoot pronation, (1,2) Achilles tendon tightness and ankle dorsiflexion diminished to 10 degrees or less, (1,6) tenderness without radiation at the posterior portion of the calcaneus in the region of the calcaneal apophysis, (1,3,4,7,9) and a gradual increase in symptoms until it became necessary to seek medical attention. (1,3)

Several other conditions that cause heel pain in children were ruled out during the diagnostic process. The other potential conditions included plantar fasciitis, Achilles tendinitis, retrocalcaneal bursitis, calcaneal stress fracture, tarsal coalition, Reiter syndrome, calcaneal osteomyelitis, heel fat pad syndrome, and tumor. (6,9) The maiority of the conditions were ruled out by the normal radiographic results, location of pain, no report of fever, lack of night pain, no appreciable edema, and no recent injuries associated with the condition. The findings of the physical therapy examination ruled out other remaining possibilities.

Intervention

The intervention plan of care was consistent with traditional interventions for a patient with Sever disease and the interventions included in the physician's referral. Interventions were therapeutic exercise, stretching, application of hot and cold packs, heel inserts, joint mobilizations, iontophoresis, and patient and family education. The physician had requested joint mobilizations, hot and cold packs, and iontophoresis, but did not specify a medication to use for iontophoresis, and the steroidal anti-inflammatory agent dexamethasone sodium phosphate (a negative ion) is customarily used. Dexamethasone sodium phosphate 0.4% also was the only aqueous topical anti-inflammatory available at the clinic. The use of steroids with children can have serious adverse effects (11); therefore, the referring physician was contacted to request a prescription for an aqueous preparation of ketoprofen as an alternative. The physician was asked whether the application of dexamethasone sodium phosphate would be acceptable until the ketoprofen could be obtained in order to avoid delays in intervention. The physician approved both requests.

Physical therapy intervention began immediately following the initial examination. Intervention consisted of unilateral manual stretching of the fight hamstring and calf muscles, followed by a therapeutic exercise program (Tab. 4). Hamstring and calf muscle stretches used a 20 [degrees] angled, dense, weight-bearing foam Slant Board. ([dagger]) The patient was shown the exercises, given time to practice and ask questions, and observed in the performance of each stretch to verify understanding and proficiency. The stretching was followed by the application of iontophoresis with the Empi Dupel Iontophoresis System ([double dagger]) using 2.0 cc of aqueous dexamethasone sodium phosphate 0.4% applied to the right posterior calcaneus at a dosage of 40 mA-min, followed by a cold pack for 15 minutes. During the iontophoresis, the patient reported discomfort; therefore, the current setting was reduced from 2.5 mA to 1.5 mA, which increased tolerance but lengthened the treatment time from approximately 16 minutes to 27.5 minutes.

During the second session, a visual inspection and manual evaluation of the right caicaneus was conducted, a pain rating was recorded (Tab. 1), and the patient and her mother were interviewed. Manual stretching and joint mobilization of the right subtalar joint were performed, as described by Hertling and Kessler. (36) Singleleg stance balance on a surface with decreased stability was initiated, using an Airex Balance Pad, ([section][section]) additional exercises were introduced to the therapeutic exercise program (Tab. 4), and the patient was instructed to add the new exercises to the home exercises and perform them twice a day. Iontophoresis was administered, following the final parameters of the previous visit. Dexamethasone sodium phosphate was again used, as the prescription for ketoprofen had not yet been obtained. On this occasion, the patient was unable to tolerate the iontophoresis for more than 2 minutes, resulting in a discontinuation of the intervention. A cold pack was applied to the right calcaneus for 15 minutes, and the initial Lower Extremity Functional Scale (LEFS) questionnaire was administered (Tab. 5). The LEFS has been demonstrated to have high test-retest reliability, construct validity, and a significant correlation between the criterion measure and the questionnaire. (37)

The patient's inability to tolerate iontophoresis prompted a consultation with a compounding pharmacy and a review of the literatur (14) to determine an alternative approach to iontophoresis and oral administration of a NSAID. The decision was made to request a prescription for a transdermal NSAID preparation, which was also in accord with the mother's preference to avoid the administration of oral NSAIDs. The referring physician was contacted with a new request for a 10% ketoprofen pluronic lecithin organogel (PLO) instead of aqueous ketoprofen. The new request was approved. The compounding pharmacy prepared the medication, which was massaged into the skin directly over the affected area.

The PLO gel was selected based on the recommendation of a pharmacist at a local compounding pharmacy and on a review of the available literature. The PLO gel is composed of Pluronic F127, a gelling agent; lecithin organogel, the vehicle for transmission of the active ingredient; and the active ingredient. (38) Lecithin organogels can be prepared easily, are stable for more than 6 months, can incorporate sizeable amounts of the active ingredient as guest molecules, and have been shown to have no harmful effect when applied to the skin for prolonged periods. (39)

Viscoelastic gel heel inserts were fit to the patient's athletic shoes; however, the athletic shoes were well worn, and her mother was advised to replace them. The selection of viscoelastic gel heel inserts was made based on their greater ability to reduce ground reaction forces (10) compared with closed cell foam inserts and the expectation of increased comfort. The Women's Massaging Gel Heel Cushions ([parallel]) were selected based on the minimum of expense ($6.49 per pair), and the ease of obtaining the inserts on short notice. The heel inserts were wedge shaped and three-eighths of an inch thick at the thickest point. The inserts were to be transferred to any shoes the patient wore, and the patient was advised to not walk barefoot. (2)

The third intervention session was the same as the second with the addition of the Hydra Fitness Athletics Seated Stair-Stepper (model 1992 (#) (Tab. 4), and a pain rating was recorded (Tab. 1). Following the therapeutic exercises and stretching, the patient and her mother were told the indications for ketoprofen gel and how to apply it. The patient's right calcaneus was prepared with isopropyl alcohol, which was allowed to air dry and evaporate, and then the ketoprofen gel was applied.

The mother was to apply the ketoprofen gel (approximately 1 g) to the patient's right posterior calcaneus 3 times each day. The amount of ketoprofen gel to be applied was determined by consultation with the pharmacist and a review of the available literature. (12,14,21) A syringe, provided by the pharmacy, was used to demonstrate the proper amount of ketoprofen gel that the mother was to apply by squeezing it from the tube. No measuring device was used in the application process, based on the findings of Patel and Leswell, (12) who concluded that use of a measuring device to aid in application and adherence offered neither clinical nor statistical benefit for the use of a ketoprofen gel. The gel could be applied either directly to the calcaneus or first onto the mother's index finger and then rubbed into the calcaneus. The mother said that not having to locate and clean a measuring device with each application was an additional benefit. The patient and her mother were both given the opportunity to ask questions and were asked to bring the ketoprofen gel on subsequent physical therapy visits, at which time she would be observed applying the gel in order to confirm proper application.

During the fourth intervention session bilateral hamstring strengthening (knee flexion) on the Model N-K 330 Knee Flexion and Extension Table ** was added to the intervention (Tab. 4). The patient reported no change in pain rating on this visit (Tab. 1), and her mother reported an increase in physical activity the previous day. Single-leg stance was limited to one repetition because the patient reported pain, possibly due to the increased activity of the previous day (Tab. 4). Following the exercises, an ice pack was applied the patient's right calcaneus and the second LEFS was administered (Tab. 5). The mother was then asked to apply the ketoprofen gel and observed to confirm that the gel was being applied in the prescribed manner.

The fifth physical therapy session was after the patient's follow-up visit with the referring physician, who said the patient could return to full activity. Following instructions she received from the physician, the mother discontinued the application of the ketoprofen gel (although not specifically instructed to do so) for 2 days prior to the fifth physical therapy visit. The patient exhibited mild pain with both the right calcaneal compression test and compression of the fight Achilles tendon insertion. The same responses were not exhibited on the previous visit.

The fifth session followed the intervention plan (Tab. 4), a pain rating was recorded (Tab. 1), and ketoprofen gel was applied. The physician requested the original heel lifts be added to the viscoelastic gel inserts for additional height. The combined height was five-eighths of an inch at the thickest point.

During the sixth session, the patient reported the lowest NRS pain rating to that date (Tab. 1) and increases in muscle strength were recorded (Tab. 2). The patient had a negative response to both the calcaneal compression test and compression of the Achilles tendon insertion. The intervention plan was followed (Tab. 4) and the ketoprofen gel was applied. The patient and her mother were educated on the benefits of continuing a daily stretching program, performing the home exercise program 3 times per week, using the heel lifts, and continuing the application of the ketoprofen gel until pain was no longer experienced. The patient was reexamined for independence in the home exercise program under family supervision, the final LEFS was administered (Tab. 5), and the patient was discharged from physical therapy.

Outcomes

The patient was seen for 6 physical therapy sessions over 18 days, and improved in all measured variables. The initial pain rating was a constant 8/10 during weight-bearing activities, and the patient's pain diminished to an infrequent 3/10 rating (Tab. 1). The LEFS scores demonstrated improvement in the patient's condition, with a 24-point increase across administrations (Tab. 5). The minimal clinically important and detectable change for the LEFS is 9 points, with a 90% confidence interval. (40) The patient's first LEFS score was 42 out of 80 points, followed by 57 out of 80 points on the second LEFS, and 66 out of 80 points on the third LEFS (Tab. 5). The change from the first to the second administration was 15 points, with particular improvement in running and recreational activities. The change from the second to the third administration was 9 points, with particular improvement noted in walking, stair climbing, and household activities. Manual muscle testing on the initial evaluation identified weakness of the right knee flexors and dorsiflexors. On final evaluation, the right knee flexors had increased from 3+/5 to 4+/5, and the right dorsiflexors increased from 4/5 to 5/5 (Tab. 2). No other changes in MMT scores from the initial to final evaluation were detected. Bilateral ROM measurements demonstrated increases in passive and active ROM or remained unchanged (within a [+ or -]3[degrees] margin for error (31)) (Tab. 3).

Two weeks after the final physical therapy visit, the physical therapist conducted a follow-up telephone interview with the mother. At that time, she reported that the patient had returned to full activities, and continued to apply ice, stretch, and use the ketoprofen gel twice a day. She also reported that the patient was not experiencing pain and, in the absence of pain, the physical therapist advised the mother to discontinue the use of ketoprofen gel at that time. Another follow-up with the mother occurred approximately 8 months after the patient's discharge from physical therapy. The mother reported that the patient continued at a full level of activity and had no complaints of heel pain.

Discussion

The time until pain relief and return to activity for girls with Sever disease usually ranges from 1 to 6 months, with an average of 1.6 months (48 days). (2,6) In this case, the patient returned to activity 18 days after physical therapy intervention began. The initial intervention plan was typical for patients with Sever disease, with the addition of the previously undocumented application of a ketoprofen gel to the affected calcaneus because of the patient's intolerance of iontophoresis. The patient's improvement accelerated following commencement of the application of ketoprofen gel. The temporary discontinuation of the ketoprofen gel coincided with an increase in the patient's symptoms, which subsequently diminished with the resumption of the ketoprofen gel application. This suggests that the anti-inflammatory and analgesic benefits of the ketoprofen gel may have facilitated a decrease in the patient's pain, and potentially the reduced recovery time. Alternately, the stretching program, which coincided in timing with the application of ketoprofen gel, may have relieved tension of the Achilles tendon on the calcaneus, thus decreasing the patient's pain.

The inflammatory nature of Sever disease has been questioned, suggesting the condition may be due to repetitive overuse injury that does not involve inflammation of the apophysis. Repetitive overuse injury can result in stress injury of the calcaneal trabecular metaphsyeal bone, causing pain, microfailure, hemorrhage, and edema. (11) The variable response of patients with Sever disease to anti-inflammatory medications would appear to support this view, and suggests that the condition is not a well-defined inflammatory condition. (41) Therefore, it is possible that the patient responded to the analgesic effects of the ketoprofen gel and not the antiinflammatory effects, if a response to the ketoprofen gel occurred.

The patient's pain rating on the NRS decreased during the period of physical therapy both in intensity and frequency. The NRS was selected based on the ease of administration and the expected ability of the patient to understand it. The first administration was done both verbally and in writing, with the descriptors of "no pain" for 0 and "the worst pain imaginable" for 10. All subsequent administrations were only done verbally. Some researchers have drawn into question the reliability of pain ratings from children under the age of 16 years, (42) whereas other researchers have determined that the children 8 years of age and above can generally apply the standard VAS for pain successfully. (43) Taking into consideration these conflicting viewpoints, pain ratings may still offer valuable insight into the patient's view of the progress of his or her condition.

The patient's MMT scores for the right dorsiflexors and right knee flexion improved. Her reduced time of recovery leads to the question as to whether the strength increase over the 18-day period of physical therapy intervention was a true increase in strength or the result of deceased pain. The patient's inability to fully withstand the forces applied during the initial tests may be attributable to pain (although she reported none) rather than actual muscle weakness. Dorsiflexion and knee flexion tests can cause increased stressed on the calcaneus and, in conjunction with decreased extensibility of the Achilles tendon, result in pain. The stress on the calcaneus may have aggravated the patient's pain and resulted in a score that did not represent the true strength of the muscles being tested.

The LEFS was selected as an outcome measure to gauge the patient's functional improvement, Selection of this measure was based on the efficiency of administration, ease of scoring, and ease of understanding for the 8-year-old patient. The increasing scores with each administration indicated positive changes, with the greatest change being between the first and second administrations. This change coincided with the first 3 consecutive days of 3 times daily ketoprofen gel application.

A particular limitation of LEFS as an outcome measure was the patient's age and her understanding of the test, It is difficult to judge the reliability of her answers, which may have been what she perceived the interviewer wanted to hear. Care was taken to allow her to answer questions without prompting, and she was encouraged to take the time to consider the questions before answering. The patient also was assured that there were no right or wrong answers.

The possibility exists that the patient's recovery was not affected by the application of the ketoprofen gel. The patient demonstrated a considerably shorter then average recovery time at 18 days; however, Madden and Mellion (6) described the shortest range for recovery to be 14 days to 2 months. Micheli and Ireland (2) have documented the next shortest time for recovery at 1 month. The patient's condition may have resolved over a similar period of time, as experienced, without the application of the ketoprofen gel.

The patient's pain was relieved during the course of physical therapy intervention; however, passive right dorsiflexion did not increase much from baseline. A fight Achilles tendon is one of the primary symptoms associated with Sever disease, (1,2,5-7) and a greater increase in passive dorsiflexion over the course of intervention might have been expected. Several possibilities exist to explain the patient's improvement: the ketoprofen gel alone may have decreased the inflammatory process and pain sufficiently to relieve the symptoms; the stretching of the Achilles tendon may have relieved enough tension on the calcaneus to result in decreased pain, even without an increase in passive dorsiflexion; the viscoelastic heel inserts may have relieved enough tension on the Achilles tendon and decreased the shock applied to the calcaneus during ambulation to reduce the pain; or the patient's cessation of physical activities for 3 weeks may have provided the necessary recuperative time for the pain to have subsided. It is not likely that any one factor was solely responsible for the patient's recovery, the cumulative effects may have been important. The potential of reoccurrence due to increased intensity of activity, changes in physical activities, decreased extensibility of the Achilles tendon, or a growth spurt remains. Care and preventative measures (stretching, strengthening, icing, and proper footwear) should be taken to avoid a relapse and future aggravation of the condition.

The patient reported none of the potential local adverse effects associated with the application of a transdermal ketoprofen preparation. (14,18) The ease of application may have afforded a high level of adherence, and the lack of a measuring device did not appear to adversely effect the usage. (21) The transdermal delivery method also minimized the risk of adverse effects associated with oral NSAIDs. (14,18)

The addition of the ketoprofen gel was not intended to replace physical therapy intervention for this patient; rather it was intended to augment the other interventions. Based on the positive outcomes and other investigations, (14-16,18,19,21) further investigation of the use of ketoprofen gel as an anti-inflammatory and analgesic agent to manage conditions involving other apophyses, plantar fascia, tendons, ligaments, joints, cartilage, and muscles may be warranted. The addition of the ketoprofen gel to other interventions might decrease recovery times, allowing patients to return to normal activity levels sooner.

This article was received March 2, 2005, and was accepted September 6, 2005.

References

(1) Sever JW. Apophysitis of the os calcis. New York Medical Journal. 1912;95:1025-1029.

(2) Micheli LJ, Ireland ML. Prevention and management of calcaneal apophysitis in children: an overuse syndrome. J Pediatr Orthop. 1987;7: 34-38.

(3) McKenzie DC. Taunton JE, Clement DB. et al. Calcaneal epiphysitis in adolescent athletes. Can J Appl Sport Sci. 1981;6:123-125.

(4) Adirim TA. Cheng TL. Overview of injuries in the young athlete. Sports Med. 2003;33:75-81.

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* McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC Inc. Camp Hill Rd, Ft Washington, PA 19034.

([dagger]) OPTP, PO Box 470009. Minneapolis, MN 55447.

([double dagger]) Empi, 599 Cardigan Rd, St Paul, MN 55126.

([section][section]) Alcan Airex AG, Specials. Foams, CH-5643 Sins, Switzerland.

([parallel]) CVS Pharmacy Inc, Woonsocket, RI 02895.

(#) Hydra Fitness Athletics Inc. PO Box 599. 2121 Industrial Park Rd, Belton. TX 76513.

** N-K Products Inc, 2500 Rosedale Ave. Soquel. CA 95073.

RL White, PT, DPT, is a physical therapist with BenchMark Physical Therapy, 2550 Windy Hill Rd, Suite 208, Marietta. GA 30067 (USA).

The author thanks his patient and her mother for their support in the presentation of her case. The author acknowledges Paul Mattson, PT, MPT, ATC, CSCS, for providing consultation and Susan Freed, PT, DPT, PCS, for reviewing the manuscript prior to submission.

Table 1.
Patient's Numerical Pain Scale Ratings Across Physical Therapy
Intervention Sessions

          Pain
Session   Rating (a)   Pain Frequency (b)

1         8/10         Constant
2         8/10         Constant
3         6/10         Intermittent
4         5/10         Occasional
5         5/10         Intermittent
6         3/10         Infrequent

(a) Pain rating on a scale of 0 to 10, with 0="no pain" and 10="worst
pain imaginable." Throughout physical therapy treatment, patients
pain would reach 0/10 at times.

(b) Pain frequency in weight bearing: constant, intermittent,
occasional, and infrequent.

Table 2.
Manual Muscle Test Results (a)

                        Initial Visit    Final Visit

Left lower extremity    Within normal    Within normal
                          limits (5/5)     limits (5/5)

Right knee flexors      3+/5             4+/5
Right knee extensors    5/5              5/5
Right dorsiflexors      4/5              5/5
Right plantar flexors   5/5              5/5

(a) Five-point scale: O=no palpable muscle connection,
5=subject moves the tested part through complete range of
motion against gravity and withstands maximum amount of resistance.

Table 3.
Range-of-Motion Measurements (Active Range of Motion, Passive
Range of Motion) (a)

                  Initial Visit

Ankle Motion      Right                      Left

Inversion         48[degrees], 56[degrees]   62[degrees], 68[degrees]
Eversion          20[degrees], 22[degrees]   20[degrees], 26[degrees]
Dorsiflexion       6[degrees], 10[degrees]    6[degrees], 10[degrees]
Plantar flexion   74[degrees], 76[degrees]   73[degrees], 76[degrees]

                  Final Visit

Ankle Motion      Right                      Left

Inversion         50[degrees], 59[degrees]   63[degrees], 68[degrees]
Eversion          25[degrees], 35[degrees]   22[degrees], 32[degrees]
Dorsiflexion       5[degrees], 12[degrees]   12[degrees], 20[degrees]
Plantar flexion   75[degrees], 80[degrees]   75[degrees], 78[degrees]

(a) A margin of error of [+ or -] 3[degrees] defines
a detectable change in range of motion.

Table 4.
Therapeutic Exercises Across Intervention Sessions

                          Session

Exercise                  1                     2

Thera-Bond (a) (color,
    sets x repetitions)
  Ankle dorsiflexion                            Blue 2 x 10
  Ankle plantar flexion                         Blue 2 x 10
  Ankle inversion                               Blue 2 x 10
  Ankle eversion                                Blue 2 x 10
Slant Board (b) calf      2 x 2                 2 x 2
    stretch (min)
Hamstring muscle stretch  2 x 30                2 x 30
    (s)
Airex (c) single-leg                            2 repetitions = 27.5
    stance (mean time
    [s])
Seated Stair-Stepper (d)
    (min)
N-K Table (e) knee
    flexion

                          Session

Exercise                  3                     4

Thera-Bond (a) (color,
    sets x repetitions)
  Ankle dorsiflexion      Blue 2 x 10           Blue 3 x 10
  Ankle plantar flexion   Blue 2 x 10           Blue 3 x 10
  Ankle inversion         Blue 2 x 10           Blue 3 x 10
  Ankle eversion          Blue 2 x 10           Blue 3 x 10
Slant Board (b) calf      2 x 2                 2 x 2
    stretch (min)
Hamstring muscle stretch  2 x 30                2 x 30
    (s)
Airex (c) single-leg      3 repetitions = 27.3  1 repetition = 37
    stance (mean time
    [s])
Seated Stair-Stepper (d)  5                     7
    (min)
N-K Table (e) knee                              2 x 10 5 lb
    flexion

                          Session

Exercise                  5                     6

Thera-Bond (a) (color,
    sets x repetitions)
  Ankle dorsiflexion      Black 2 x 10          Black 2 x 10
  Ankle plantar flexion   Black 2 x 10          Black 2 x 10
  Ankle inversion         Black 2 x 10          Black 2 x 10
  Ankle eversion          Black 2 x 10          Black 2 x 10
Slant Board (b) calf      2 x 2                 2 x 2
    stretch (min)
Hamstring muscle stretch  2 x 30                2 x 30
    (s)
Airex (c) single-leg      3 repetitions = 25.3  3 repetitions = 39
    stance (mean time
    [s])
Seated Stair-Stepper (d)  7                     7
    (min)
N-K Table (e) knee        3 x 10 5 lb           3 x 10 5 lb
    flexion

(a) The Hygenic Corp, 124.5 Home Ave. Akron, OH 44310.

(b) OPTP, PO Box 470x)09, Minneapolis, MN 55447.

(c) Alcan Airex AG, Specialty Foams; CH-5643 Sins, Switzerland.

(d) Hydra Fitness Athletics Inc, PO Box 599, 2121 Industrial Park
Rd; Belton, TX 76513.

(e) N-K Products Inc, 2500 Rosedale Ave, Soquel, CA 95073.

Table 5.
Lower-Extremity Functional Scale Results (a)

                         Point
Administration   Score   Difference (b)

1-2/27/04        42/80
2-3/03/04        57/80   +15
3-3/12/04        66/80   +9

(a) Twenty functional activities questions, each scored 0-4
(0=extreme difficulty or unable to perform activity, 1=quite
a bit of difficulty, 2=moderate difficulty, 3=a little bit
of difficulty, 4=no difficulty). Maximum attainable score=20
x 4=80 points. Patient score=sum of scores for the 20 questions/
maximum attainable score.

(b) Minimal level of detectible change and minimal clinically
important difference (90% confidence interval)=9 points.