Complex Regional Pain Syndrome Type I Clinical Trial
Official title:
Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain
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.
Patients with Reflex Sympathetic Dystrophy (RSD), 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 RSD 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06100107 -
Mirror Therapy in Complex Regional Pain Syndrome Type I
|
N/A | |
Recruiting |
NCT05877612 -
Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs
|
||
Terminated |
NCT03309774 -
Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
|
N/A | |
Completed |
NCT00625976 -
Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
|
N/A | |
Not yet recruiting |
NCT06302920 -
Effect of Kinesiotaping on Pain,Edema and Kinesiophobia in Patients With Complex Regional Pain Syndrome
|
N/A | |
Recruiting |
NCT04703647 -
Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS) Patients
|
||
Completed |
NCT03377504 -
Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1
|
N/A | |
Recruiting |
NCT06306157 -
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
|
Phase 4 | |
Recruiting |
NCT05745025 -
rTMS and Rehabilitation for Individuals With CRPS Type 1
|
N/A | |
Terminated |
NCT04667364 -
Pain in Complex Regional Pain Syndrome
|
N/A |