Cognitive-behavior Therapy for MS-Related Chronic Pain
Cognitive-behavior Therapy for MS-Related Chronic Pain
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Pain Intensity | Mean Difference (Final Values) 0.644 | -1.058–2.345 | 0.320 |
| Pain Intensity | Mean Difference (Final Values) -0.108 | -2.106–1.888 | .911 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Cognitive-behavior therapy
Compared with
- Interventional
Results by group
Pain Intensity
baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitive-behavior Therapy | 5.31 units on a scale | 2.213 (Standard Deviation) | 13 |
| Educational Intervention | 5.42 units on a scale | 2.61 (Standard Deviation) | 12 |
Cognitive-behavior Therapy
Educational Intervention
p = .911; Mean Difference (Final Values) -0.108 (95% CI -2.106–1.888)
Pain Intensity
Baseline to Post Treatment (12 weeks)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitive-behavior Therapy | 5.76 units on a scale | 1.53 (Standard Deviation) | 13 |
| Educational Intervention | 5.12 units on a scale | 2.51 (Standard Deviation) | 12 |
Cognitive-behavior Therapy
Educational Intervention
p = 0.320; Mean Difference (Final Values) 0.644 (95% CI -1.058–2.345)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Cognitive-behavior Therapy | 13 | 0 (0.0%) | |
| Educational Intervention | 12 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Pain Intensity
baseline
PainPain Intensity
Baseline to Post Treatment (12 weeks)
Pain
Who could take part
MS (type not specified) · 21 and over
Show the full criteria
Inclusion criteria
* a confirmed diagnosis of Multiple Sclerosis, * history of daily pain or discomfort (burning, tingling or other parenthesis) for a period of 3 months immediately prior to enrollment, * judgment of one of the study neurologists (AL or MK) that the pain reported by the patient is either directly [e.g., pain associated with optic neuritis and neuralgias] or indirectly related [e.g., pain due to painful muscle contractures and spasms] to MS and/or its treatment (persons with pain that is judged to be entirely coincident with MS [e.g., idiopathic low back pain] will not be included), * documentation of optimal pharmacological management of MS-related pain and confirmation of this judgment by one of the study neurologists, * continued use of appropriate pharmaceuticals for the management of MS and pain, and * continued refractory pain despite pharmaceutical intervention as described above (as determined by a pain intensity score 4 on a 0-10 numeric rating scale).
Exclusion criteria
* pending surgery or interventional anesthesiological procedures for pain, * currently psychotic or actively suicidal or homicidal, * current alcohol or substance abuse or dependence, * presence of other life threatening illnesses, * the presence of profound cognitive impairment rendering successful participation in CBT or ED impossible, * the presence of physical disabilities resulting in an inability to attend treatment sessions and/or inability to participate in telephone interventions (e.g., severe dysarthria), * prior or current psychological treatment for chronic pain, * two or more documented exacerbations of MS-related symptoms during the past year, and * current exacerbation of symptoms defined as sudden onset of symptoms within a 24 hour period. Participants experiencing an exacerbation will be included after a one-month period of appropriate treatment or three months after the onset of the exacerbation. The Exacerbation Questionnaire, also described below and developed by Dr. Mohr, one of our co-investigators, will be used to assess and monitor significant exacerbations of MS. The Multiple Sclerosis Functional Composite (MSFC) score described below will be used to determine these later two exclusion criteria.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to evaluate the efficacy of a brief psychological intervention, cognitive-behavior therapy, for the management of persistent pain associated with Multiple Sclerosis.
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History
Started
Jul 2006
Main results due
Mar 2011
Finished
Mar 2011
Results posted
Sept 2015