Protocol Number: 00-NR-0200


Title: Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain Number: 00-NR-0200 Summary: This study will examine the effectiveness of the drug neurotropin in treating chronic pain after injury to a limb or a large nerve. Two groups of patients will participate in this study: patients with complex regional pain syndrome type 1, or CRPS-I (also called reflex sympathetic dystrophy) and patients with complex regional pain syndrome type 2, or CRPS-II. CRPS-I is pain that develops after relatively minor injury to an arm or leg, but lasts much longer and is much more severe than would normally be expected. CRPS-II is pain resulting from injury to a large nerve. Candidates will have a history and physical examination, blood tests, and electrocardiogram. Participants will undergo the following tests and procedures:
Patients with CRPS I and II will receive an individualized regimen of physical therapy and standard treatment to control their pain. In addition, they will receive neurotropin or placebo tablets for 5 weeks, then no trial medicine for at least 1 week, and then the other trial drug for the next 5 weeks. That is, patients who took placebo the first 5 weeks will take neurotropin the second 5 weeks and vice versa. Neither the patients nor the doctors will know who received which drug during the two intervals until the study is over. Patients will complete questionnaires about their pain, quality of life, and ability to perform daily living activities. They will have various tests to measure pain (such as sensitivity to heat and cold, to an electric current, to a mild pin prick, etc.); to provide information about changes in their condition (such as tests of range of motion of joints and limb size); to measure blood circulation and sweating in the arm or leg (such as measurements of blood flow to the limb, skin temperature, and sweat production), and other procedures.

Sponsoring Institute: National Institute of Nursing Research (NINR) Recruitment Detail Type: Participants currently recruited/enrolled Gender: Male & Female Referral Letter Required: No Population Exclusion(s): Pregnant or Nursing
Eligibility Criteria:

INCLUSION CRITERIA
Dental outpatients undergoing elective removal of impacted third molars based on a preoperative diagnosis of the type and number of teeth to be extracted. The difficulty of extraction will be classified based on clinical exam and a panoramic radiograph as simple extraction (1), soft tissue impaction (2), partial boney impaction (3), or full boney impaction (4). Both lower teeth to be extracted should be similarly boney impacted, and the score for each of the two lower teeth should be 3 to 4. Uppers are usually in soft tissue. The diagnosis for each tooth will be confirmed by the oral surgeon after the procedure based on the surgical procedure actually performed.

CRPS patients are referred with a diagnosis of CRPS-I or CRPS-II in one limb only, based on pain (1) that is post-traumatic and spread beyond the region of the injury; (2) has persisted for more than 2 weeks; and (3) is associated with swelling, altered skin color or skin temperature, altered sweating, allodynia or hyperesthesia or limitation of active movement. Atrophic changes in skin, hair loss or nail changes, or disuse atrophy of skeletal muscle may be present.

Both sexes are to be studied.

Children can participate, if they can provide adequate self-ratings.

All ethnic and racial groups can participate.

Patients must be willing to return to NIH for follow-up evaluation under this protocol.

EXCLUSION CRITERIA

Dental outpatients must not be taking any medications chronically (with the exception of oral contraceptive agents).

Pregnant and lactating women are excluded.

Based on the oral surgeon's postoperative diagnosis, any extraction which is classified as producing unusual surgical trauma will result in exclusion from the remainder of the study.

Dental subjects will also be excluded if they are not adequately sedated by midazolam alone and require intraoperative administration of an opioid drug such as fentanyl, administration of greater than 14.4 ml of local anesthetic (2% lidocaine with 1:100,000 epinephrine), or postoperative administration of a steroid for possible injury to the inferior alveolar nerve.

Patients referred with CRPS-I or CRPS II who have abnormal screening test results or who have non-tramatic disorders to which pain may be attributed (gout, malignancy, arthritis, etc.) will be excluded.

Any patients who have had ablative procedures for treatment of their neuropathic pain disorder will not be eligible for inclusion in this study.

Subjects with impaired mental capacity that precludes informed consent and children who cannot provide adequate self-ratings are excluded.

Patients who have a positive HIV result will be excluded.

Special Instructions:

Currently Not Provided

Keywords: Analgesia Causalgia CRPS Neuropathic Pain Oral Surgery Reflex Sympathetic Dystrophy Sympathetic Nervous System Chronic Regional Pain Syndrome Recruitment Keyword(s): None Condition(s): Causalgia Reflex Sympathetic Dystrophy Investigational Drug(s): Neurotropin Investigational Device(s): None Intervention(s): Drug: Neurotropin Supporting Site: National Institutes of Nursing Research Contact(s): Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793
Electronic Mail:prpl@mail.cc.nih.gov Citation(s): Reflex sympathetic dystrophy: changing concepts and taxonomy IASP diagnostic criteria for complex regional pain syndrome: a preliminary empirical validation study International Association for the Study of Pain External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria International Association for the Study of Pain
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