Cognitive-behavior Therapy for MS-Related Chronic Pain

Completed · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00323271

Run by

US Department of Veterans Affairs

People needed

26

Starts

2006-07-01

Expected to finish

2011-03-01

Last updated by the study team

2015-09-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
• VA Medical Center, Jamaica Plain Campus — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.