Reflex Sympathetic Dystrophy Syndrome
Complex Regional Pain Syndrome
RSD(S)-CRPS Advisory
Complex Regional Pain Syndrome
RSD(S)-CRPS Advisory
Clinical Trial: Neurotropin to Treaat Chronic Neuropathic Pain
Neurotropin to Treat Chronic Neuropathic Pain
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2007
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006289
Purpose
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.
Condition Intervention Phase
Causalgia
Reflex Sympathetic Dystrophy
Drug: Neurotropin
Phase II
Genetics Home Reference related topics: Peripheral Nerve Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
Efficacy of Neurotropin for acture pain.
Enrollment: 100
Start Date: September 2000
Detailed Description:
Patients with Reflex Sympathetic Dystrophy, re-named Complex Regional Pain Syndrome,
type I (CRPS-I), have chronic, post-traumatic pain that spreads beyond the distribution of
any single peripheral nerve without evidence of major peripheral nerve damage. A similar
disorder, Causalgia, re-named CRPS-II, presents with clear evidence of nerve injury. No
successful drug treatment exists for these disorders. Neurotropin is a non-protein extract
of cutaneous tissue from rabbits inoculated with vaccinia virus. Neurotropin has been used
extensively in Japan to treat reflex sympathetic dystrophy and other painful conditions;
however, the drug has not undergone clinical therapeutic testing in the United States. This
protocol is to carry out double-blind, placebo-controlled, crossover studies about clinical
efficacy of Neurotropin for acute pain in dental outpatients and for chronic pain in
outpatients with CRPS-I or II.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006289
Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222
prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting Bethesda,
Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
More Information
NIH Clinical Center Detailed Web Page
Publications:
Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N,
Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex
Regional Pain Syndrome and proposed research diagnostic criteria. International
Association for the Study of Pain. Pain. 1999 May;81(1-2):147-54.
Study ID Numbers: 000200, 00-NR-0200
First Received: September 21, 2000
Last Updated: September 22, 2007
ClinicalTrials.gov Identifier: NCT00006289
Health Authority: United States: Federal Government
Keywords provided by National Institutes of Health Clinical Center (CC):
Analgesia
Causalgia
CRPS
Neuropathic Pain
Oral Surgery
Reflex Sympathetic Dystrophy
Sympathetic Nervous System
Chronic Regional Pain Syndrome
Study placed in the following topic categories:
Reflex Sympathetic Dystrophy
Immunologic Factors
Neuralgia
Toothache
Neurotropin
Adjuvants, Immunologic
Pain
Reflex sympathetic dystrophy syndrome
Autonomic Nervous System Diseases
Complex Regional Pain Syndromes
Neuromuscular Diseases
Peripheral Nervous System Diseases
Causalgia
Biological Response Modifiers
Analgesics
Anticonvulsants
Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Reflex Sympathetic Dystrophy
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
ClinicalTrials.gov processed this record on December 03, 2007
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2007
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00006289
Purpose
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.
Condition Intervention Phase
Causalgia
Reflex Sympathetic Dystrophy
Drug: Neurotropin
Phase II
Genetics Home Reference related topics: Peripheral Nerve Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
Efficacy of Neurotropin for acture pain.
Enrollment: 100
Start Date: September 2000
Detailed Description:
Patients with Reflex Sympathetic Dystrophy, re-named Complex Regional Pain Syndrome,
type I (CRPS-I), have chronic, post-traumatic pain that spreads beyond the distribution of
any single peripheral nerve without evidence of major peripheral nerve damage. A similar
disorder, Causalgia, re-named CRPS-II, presents with clear evidence of nerve injury. No
successful drug treatment exists for these disorders. Neurotropin is a non-protein extract
of cutaneous tissue from rabbits inoculated with vaccinia virus. Neurotropin has been used
extensively in Japan to treat reflex sympathetic dystrophy and other painful conditions;
however, the drug has not undergone clinical therapeutic testing in the United States. This
protocol is to carry out double-blind, placebo-controlled, crossover studies about clinical
efficacy of Neurotropin for acute pain in dental outpatients and for chronic pain in
outpatients with CRPS-I or II.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006289
Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222
prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting Bethesda,
Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
More Information
NIH Clinical Center Detailed Web Page
Publications:
Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N,
Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex
Regional Pain Syndrome and proposed research diagnostic criteria. International
Association for the Study of Pain. Pain. 1999 May;81(1-2):147-54.
Study ID Numbers: 000200, 00-NR-0200
First Received: September 21, 2000
Last Updated: September 22, 2007
ClinicalTrials.gov Identifier: NCT00006289
Health Authority: United States: Federal Government
Keywords provided by National Institutes of Health Clinical Center (CC):
Analgesia
Causalgia
CRPS
Neuropathic Pain
Oral Surgery
Reflex Sympathetic Dystrophy
Sympathetic Nervous System
Chronic Regional Pain Syndrome
Study placed in the following topic categories:
Reflex Sympathetic Dystrophy
Immunologic Factors
Neuralgia
Toothache
Neurotropin
Adjuvants, Immunologic
Pain
Reflex sympathetic dystrophy syndrome
Autonomic Nervous System Diseases
Complex Regional Pain Syndromes
Neuromuscular Diseases
Peripheral Nervous System Diseases
Causalgia
Biological Response Modifiers
Analgesics
Anticonvulsants
Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Reflex Sympathetic Dystrophy
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
ClinicalTrials.gov processed this record on December 03, 2007
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