Selected Ongoing Clinical Trials [*].

1. IMPROVING CANCER PAIN MANAGEMENT USING AHCPR CANCER PAIN GUIDELINES.

This placebo-controlled, single-blind, factorial design, randomized, controlled trial will compare the effectiveness of two strategies using recommendations developed by the Agency for Health Care Policy and Research, US Department of Health and Human Services, for managing cancer pain with standard care. The objective is to determine if these strategies are more effective in decreasing cancer pain, improving quality of life or functional status than standard pain management. Both men and women with a medical diagnosis of cancer are eligible if they have pain as a result of cancer or cancer treatment; are being treated on an out-patient basis and taking their own medications; have a life expectancy of at least six months; have access to a telephone; have the ability to read and speak English; and have no history of drug abuse.

Contact. Marilyn K. Douglas, DNSc, RN, VA Palo Alto Health Care System, Palo Alto, CA 94304-1207. [phone]. E-mail: Marilyn. [e-mail]

2. INFLUENCE OF GENETICS IN PAIN SENSITIVITY.

This Phase II clinical trial is designed to learn more about the role of genetics in pain sensitivity The study will consist of two parts: sensitivity testing for hot and cold, and oral surgery. All participants will take part in the first section, and patients needing oral surgery for removal of third molars may participate in the second section. The study seeks to investigate genetic contributions to acute experimental and clinical post-operative pain. Both men and women are eligible if they need oral surgery for removal of an impacted third molar; are not using prescription and nonprescription analgesics, antihistamines, and antidepressants; have no history of psychiatric or neurological disorders or a positive score on the Beck Depression Inventory; and are not pregnant or nursing.

Contact: National Institute of Dental and Craniofacial Research, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

3. SENSORY TESTING TO ELUCIDATE MECHANISMS OF NEUROPATHIC PAIN.

This natural history study will observe changes in neuropathic pain during a number of techniques that activate, inactivate; or assess the function of selective groups of nerve fibers in order to understand the physiological mechanisms of pain. Both men and women are eligible if they are pain free; have spontaneous pain and/or abnormal evoked-pain sensations; are at least 18 years of age with a duration of pain of at least two months; have spontaneous pain that is relatively constant; have allodynia and/or hyperalgesia with or without spontaneous pain; and have stable medical conditions without poor cognitive functions or psychosis.

Contact: National Institute of Dental and Craniofacial Research, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

4. A PHASE I TRIAL OF BRIEF INTRAVENOUS INFUSION OF THE AMPA RECEPTOR BLOCKER LY293558 TO EXAMINE SAFETY AND EFFECTS OF PAIN PERCEPTION IN NORMAL VOLUNTEERS.

This Phase I clinical trial is designed to: determine the toxicity associated with the maximally tolerated dose of AMPA receptor blocker LY293558 in normal patients; assess the effect of AMPA receptor blockade on normal pain perception; and determine the efficacy on the intense pain evoked by intradermal capsaicin. Men are eligible if they are determined healthy by physical examination; are between 21 to 50 years old; weigh within 10 percent of ideal body weight; have no history of clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic or other chronic disease, alcoholism or drug abuse; and have no conditions requiring regularly administered systemic medications.

Contact: National Institute of Dental and Craniofacial Research, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

5. SCREENING STUDY FOR THE EVALUATION AND DIAGNOSIS OF POTENTIAL RESEARCH SUBJECTS IN ACUTE AND CHRONIC PAIN PROTOCOLS.

This study will screen patients with either diagnosed or undiagnosed conditions or normal volunteers. It will serve as a first step for individuals who may be eligible to participate in pain clinical research studies. Eligibility for both men and women will vary with the particular protocol for which a patient is screened. Individuals will be referred by medical and dental practitioners in the private sector, clinics, hospitals, medical institutions, and the Occupational Medical Services at the National Institutes of Health.

Contact: National Institute of Dental and Craniofacial Research, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

6. PAIN MEASUREMENT.

This natural history study will develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in clinical populations. Both men and women without painful diseases; histories of significant illnesses; poor general health or histories of psychotic disorders; or heart, lung or liver diseases are eligible.

Contact: National Institute of Dental and Craniofacial Research, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail. [e-mail]

7. NEUROTROPIN TO TREAT ACUTE DENTAL AND CHRONIC NEURAL PAIN.

This Phase II clinical trial will examine the effectiveness of the drug neurotropin in treating acute pain after tooth extraction and chronic pain after injury to a limb or a large nerve. Both men and women who are dental patients undergoing removal of impacted third molars (wisdom teeth); have chronic regional pain syndrome type 1, or CRPS-I (also called reflex sympathetic dystrophy); have chronic regional pain syndrome type 2, or CRPS-II are eligible.

Contact: National Institute of Dental and Craniofacial Research, 9000 Rockville Pike, Bethesda, MD 20892. [phone]. E-mail: [e-mail]

8. EFFECTS OF REIKI ON PAINFUL NEUROPATHY AND CARDIOVASCULAR RISK FACTORS.

This Phase II, single-blind, randomized, controlled trial will apply Reiki (an energy manipulation technique used to relieve chronic pain and accelerate healing in full thickness dermal wounds) to patients with diabetic painful neuropathy (DPN) and diabetic autonomic neuropathy (DAN). The technique will determine if glycemic control and cardiac autonomic functions are improved. Both men and women aged 20 to 80 years who are diagnosed with DPN +/- or DAN for at least six months; have stable diabetes; have the ability to give informed consent and the willingness to sign the Institutional Review Board approved consent form; are willing to cooperate with medical therapy and follow up for the 12-month study; and have the ability to understand English are eligible. This study was not open for patient recruitment at the time of this manuscript preparation.

Contact: Steven F Boiling, Taubman Center, Ann Arbor, MI 48109-0344. [phone]. Email: [e-mail]

9. EFFICACY OF ACUPUNCTURE IN THE TREATMENT OF FUBROMYALGIA.

This Phase I controlled trial will evaluate the short and long-term efficacy and side effects of a 12-week trial of hi-weekly acupuncture in the treatment of fibromyalgia (FM); establish the most useful and scientifically sound control group for studies of acupuncture using FM as a model for conditions characterized by chronic pain; use both subjective and objective measures of overall health and pain to determine the optimal time length of treatment; and examine the concordance of allopathic and acupuncture-based measures of outcome. Both men and women aged 18 to 42 years are eligible if they are not-pregnant; are not nursing; are diagnosed with fibromyalgia; have a global pain score of> 4 on a visual analog scale; and have no other medical conditions associated with significant diffuse neuropathic, musculoskeletal, or joint pain. Further eligibility criteria are available from the point of contact. This study was not open for patient recruitment at the time of this manuscript preparation.

Contact: Debra S. Buchwald, MD, Harborview Medical Center, Seattle, WA 98104. [phone]. E-mail: debra@u. washington. edu

10. TREATMENT OF FUNCTIONAL ABDOMINAL PAIN IN CHILDREN: EVALUATION OF RELAXATION/GUIDED IMAGERY AND CHAMOMILE TEA AS THERAPEUTIC MODALITIES.

This study will investigate methods from the National Center for Complementary and Alternative Medicine aimed at alleviating chronic pain related to functional bowel disorders in children. Two modalities will be investigated independently of each other, specifically Guided Imagery, and the use of Chamomile teas as a form of botanical therapy. Both sexes aged up to 20 years with recurrent abdominal pain and irritable bowel syndrome are eligible. This study was not open for patient recruitment at the time of this manuscript preparation.

Contact: Fayez K Ghishan, University of Arizona, Department of Pediatrics, Tucson, AZ 85724-5073. (520) 626-5 1 70. E-mail. fghishan@peds. arizona. edu

11. USUAL CARE VS CHOICE OF ALTERNATIVE RX: LOW BACK PAIN.

This Phase III, randomized, controlled trial will compare two approaches to the management of acute low back pain: usual care (standard benefit) vs. choice of chiropractic, acupuncture, or massage therapy (expanded benefit). Licensed providers who have met strict credentialing criteria will provide treatments. The results of this study will provide valuable information to clinicians, patients and third party payers on the relative benefits and costs of an "expanded benefits" treatment option which incorporates chiropractic, acupuncture and massage services for low back pain. Both men and women aged 18 years and older who have had back pain for less than 21 days; have had no prior treatment or evaluation for back pain; and have the ability to read and speak English are eligible.

Contact: Andrea Hrbek, Beth Israel Deaconess Medical Center, Boston, MA 02215. [phone]. E-mail: [e-mail]

12. A PROSPECTIVE COHORT STUDY OF MRI ABNORMALITIES AND BACK PAIN RISK.

This longitudinal study will determine the prevalence and incidence of magnetic resonance imaging (MRI) abnormalities among veterans and determine the extent to which specific MRI abnormalities predict future development of back pain. The results should help clinicians use MRI more efficiently, and ultimately help reduce the frequency of unnecessary back surgery. Both men and women who are patients at a Veterans Affairs Hospital and have never had spine surgery or serious systematic medical problems are eligible.

Contact: Jay Cline, VA Puget Sound Health Care System, Seattle, WA 98108. [phone].

13. TREATMENT OF CHRONIC PAIN AFTER SPINAL CORD INJURY OR AMPUTATION.

This double-blind, placebo-controlled, single group design, randomized, controlled trial will test how pain is affected by adding methadone to a six-week program of weekly physical therapy, relaxation training and counseling. Both men and women aged 18 to 75 years with a spinal cord injury or amputation and persistent pain of three months or longer are eligible.

Contact: Jill Smith, University of Pittsburgh Medical Center, Pittsburgh, PA 15213. [phone]. E-mail: [e-mail]

14. TREATMENT FOR CHRONIC PAIN IN PATIENTS WITH ADVANCED CANCER.

This Phase III, randomized, double-blind trial will compare the effectiveness of different morphine formulations with or without dextromethorphan in treating patients with chronic pain from advanced cancer. Both men and women are eligible if they are 16 years old or older with histologically or cytologically proven advanced cancer with chronic pain; have cancer pain requiring strong opioids; and have had pain managed by a stable maintenance dose of MS-Contin formulation of morphine for at least two days.

Contact: Sharon Watanabe, Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada. [phone].

15. COMBINATION CHEMOTHERAPY IN TREATING PAIN IN PATIENTS WITH HORMONE REFRACTORY METASTATIC PROSTATE CANCER.

This Phase III, randomized, double-blind trial will compare the effectiveness of combination chemotherapy using mitoxantrone plus prednisone with or without clodronate in treating patients with hormone refractory metastatic prostate cancer. Men of any age with histologically confirmed adenocarcinoma of the prostate or metastatic carcinoma of presumptive prostate origin are eligible.

Contact: Stefan Cluck, Tom Baker Cancer Center- Calgary, Calgary, Alberta, T2N 4N2, Canada. [phone].

16. FLECAINIDE IN TREATING PATIENTS WITH CHRONIC NEUROPATHIC PAIN.

This Phase II trial will study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS. Both men and women aged 19 years and older with chronic neuropathic pain and a diagnosis of cancer or AIDS are eligible.

Contact: John W Kugler, CCOP-Illinois Oncology Research Association, Peoria, IL 61602. [phone].

17. PAIN CONTROL IN PATIENTS WITH RECURRENT OR METASTATIC BREAST OR PROSTATE CANCER.

This randomized pilot study will evaluate whether an outpatient educational and behavioral skills training program will improve pain control in patients who have metastatic or recurrent breast or prostate cancer. Men and women aged 18 years and older are eligible if they have recurrent or metastatic breast or prostate cancer; have a "pain worst" score of four or greater on the Brief Pain Inventory; and have received palliative radiotherapy to major sites of pain.

Contact: Kendrith M. Rowland, Jr., Carle Cancer Center, Urbana, IL 61801. [phone].

18. CHRONIC PAIN AFTER AMPUTATION.

This Phase IV, double-blind, placebo-controlled, randomized trial will test the effectiveness of amitriptyline in relieving chronic pain in adults who have had an amputation. Both men and women aged 18 to 65 years who have had an amputation at least six months prior to the study and pain for three months or longer are eligible.

Contact: Kellye Campbell, RN, University of Washington, Department of Rehabilitation Medicine, Seattle, WA 98195. [phone]. E-mail: [e-mail]

19. TRANSCRANIAL MAGNETIC STIMULATION FOR THE TREATMENT OF PHANTOM PAIN.

This Phase I clinical trial will apply low-frequency transcranial magnetic stimulation to posterior parietal cortex cortical areas contralateral to the side of the amputated limb to try to eliminate phantom pain. Both men and women aged 10 to 65 years with amputations and phantom pain for at least 12 months are eligible. Further eligibility criteria are available from the point of contact.

Contact: National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike, Bethesda, MD 20892. [phone]. Email: [e-mail].

20. PAIN MANAGEMENT AND BEHAVIORAL OUTCOMES IN PATIENTS WITH DEMENTIA.

This Phase II, double-blind, placebo-controlled, cross-over design, randomized, controlled trial is designed to elucidate the relationships between pain, discomfort, and agitation, and determine the influence that pain management has on decreasing discomfort, agitation, and confusion in nursing home residents. Both men and women who are 55 years old and older; are nursing home residents; have a diagnosis that would respond to Tylenol; have documented agitated behavior; have a diagnosis of dementia or a functional impairment severe enough to rate a seven on the Global Deterioration Scale; are unable to report pain; and have been residents in a nursing home for at least one month with plans to stay at least two months are eligible.

Contact: Martha Buffum, DNSc, RN, San Francisco Medical Center, San Francisco, CA 94121. [phone]. E-mail: Martha. [e-mail]

21. SUBGROUPS OF FIBROMYALGIA.

This Phase II, randomized, controlled trial will systematically evaluate the effects of matching treatment to subgroups of fibromyalgia patients based on their psychosocial and behavioral characteristics. The study will evaluate the differential responses of patients given a general rehabilitation program that includes information about fibromyalgia and physical therapy. Women aged 21 to 65 years who are diagnosed with fibromyalgia; are not pregnant; have no cardiac problems; and have no significant psychopathology are eligible.

Contact: Dennis C. Turk, PhD, University of Washington, Seattle, WA 98195. [phone]. E-mail: [e-mail]

(*.) Prepared by Elaine McClellan-Holm.