Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS

Phase 2TerminatedNCT01911377

University of Manitoba12 enrolled

Overview

This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis. Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or people with multiple sclerosis. Allodynia is a type of neuropathic pain caused by something that normally would not cause pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin. Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has recently been studied as a treatment for neuropathic pain. We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type neuropathic pain. 24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 "controls" receiving placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Neuropathic Pain Allodynia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fulfills the criteria for neuropathic pain causing allodynia according to IASP pain terminology. * Allodynia that is resistant to, or has failed, the standard level of care measures for more that six months. * Allodynia pain on a daily basis. * Allodynia pain that scores at least 4/10 on a pain numerical scale. * Other pain medications(including antidepressants and anticonvulsants)have been maintained at a stable dose for at least 2 months prior to enrollment. * Ability to communicate in English. Exclusion Criteria: * Presence of other pain syndromes (e.g.,fibromyalgia, ongoing peripheral neuropathic pain. * Allergy to Botulinum Toxin Type A. * Allergy to albumin. * Use of Botulinum Toxin Type A for other treatment indications in the 3 months prior to enrollment. * Renal failure. * Hepatic failure. * Neuromuscular junction disorders. * Bleeding diathesis. * Cognitive impairment, dementia, major depression or psychotic disorder. * Pregnant or breastfeeding. * Infection at the injection site. * Active alchohol or substance abuse.

Outcomes

Primary Outcomes

Brief Pain Inventory

The primary outcome measure will be the self-reported average pain intensity from each morning's record in a diary. The average(self-reported) pain intensity will be measured at the screening visit, then the daily diary will be dispensed. The diary will ask for the average pain intensity of the last 24 hours using an 11-point numerical scale, with 0 representing no pain and 10 representing the worst pain imaginable

Time frame: Baseline and daily until study completion at 13 weeks

Secondary Outcomes

Neuropathic Pain Symptom Inventory

This scale rates the mean intensity of 10 neuropathic pain symptoms and their combination into 5 distinct dimensions during the last 24 hours on an 11-point (0-10) numerical scale

Time frame: Baseline and follow-up visits(at weeks 1, 4, 8 and 13)

The Hospital Anxiety and Depression Scale

14 items scored as anxiety and depression

Time frame: Baseline and follow-up visits (at weeks 1, 4, 8 and 13).

Daily Sleep Interference Scale

Asks if pain interfered with sleep in the past 24 hours,using an 11-point scale (O-pain did not interfere with sleep, 10-pain completely interfered with sleep). Dispensed at baseline.

Time frame: Baseline and daily during study period until week 13.

Clinician Global Impression Scale

Assesses the clinician's impression of Efficacy and Tolerability of study medication using a 4-point scale, with 1 being Very good, and 4 being Poor

Time frame: Final visit at week 13

Patient's Global Impression Scale

Measures the patients global impression of the efficacy and tolerability of the study medication on a 4-point scale, with 1 representing very good, and 4 representing poor