N/A
N=25
Cognitive-behavior Therapy for MS-Related Chronic Pain
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00323271 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Pain Intensity — 5.31; 5.42 units on a scale — p=.911
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive-behavior therapy (Behavioral); Interventional (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity |
5.76; 5.12 | 0.320 |
| PRIMARY Pain Intensity |
5.76; 5.12 | 0.320 |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00323271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.