Status:
COMPLETED
Cognitive-behavior Therapy for MS-Related Chronic Pain
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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.
Detailed Description
The primary purpose of the proposed study is to evaluate the feasibility and efficacy of tailored CBT with standard pharmaceutical care (CBT/SC) in reducing pain, disability, and distress among person...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00323271
Start Date
July 1 2006
End Date
March 1 2011
Last Update
September 25 2015
Active Locations (2)
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1
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
2
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130