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Relaxation Training to Decrease Pain and Improve Function in Adolescents with Cerebral Palsy - Article


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Dejerine-Klumpke Palsy


Clinical Trial: Relaxation Training to Decrease Pain and Improve Function in Adolescents with Cerebral Palsy

This study is currently recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

This study will examine the effectiveness of relaxation training for providing pain relief and improving physical and psychological functioning in youth with physical disabilities due to cerebral palsy.

Condition Treatment or Intervention
Cerebral Palsy
 Behavior: biofeedback-monitored relaxation training

MedlinePlus related topics:  Cerebral Palsy

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Efficacy of Relaxation Training

Further Study Details: 

Expected Total Enrollment:  60

Study start: March 2003;  Expected completion: March 2006

Chronic pain is a serious problem in many youths with disabilities. There is a growing body of research supporting the efficacy of relaxation training for reducing chronic pain in adults. Given this evidence, there has been a growing interest in determining whether these findings also generalize to youths with chronic pain. This study will address a significant gap in the medical literature by examining the efficacy of relaxation training for providing pain relief and improving function in youths with physical disabilities. The study will evaluate the effects of relaxation training on global physiological arousal, pain-site specific muscle tension, and perceived control over pain. Physiological arousal will be assessed via hand temperature and galvanic skin response. Muscle tension will be assessed via surface EMG biofeedback recordings before, during, and after each treatment session. Self-efficacy concerning pain control will be assessed via a modified Survey of Pain Attitudes and modified Coping Strategies Questionnaire.

Sixty youth (age range 10 to 20 years old) with spastic type cerebral palsy (CP) will be randomly assigned to either the relaxation training group or a distraction control group. Youths in the relaxation training group will be given eight sessions of autogenic relaxation training and will be asked to practice relaxation at home using audio tapes. Youths in the distraction control group will receive eight sessions of distracting story-telling and will be asked to listen to age-appropriate audio tapes of stories at home. Study visits are scheduled weekly for eight weeks. Average pain intensity will be assessed with a numerical rating scale. Secondary outcome measures include psychological functioning and pain interference with personal activities. Medical services utilization will be assessed by asking the parent or guardian about any medications taken by the participant, any illnesses or medical complications, any medical treatments received, and the frequency of health care visits. Participants will be assessed at 1, 3, 6, 9, and 12 months after treatment.

Eligibility

Ages Eligible for Study:  10 Years   -   20 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Cerebral palsy
  • Referred by the study physician
  • Chronic cerebral palsy-related pain for at least 3 months prior to study entry. The pain needs to have an average daily occurrence of 3 on a 0 to 10 scale, where 0 is no pain and 10 is extreme pain.
  • Primary language is English

Exclusion Criteria

  • Acute painful conditions
  • Cognitive impairment as determined by a score < 12 on the modified Mini-Mental Status Exam

Location and Contact Information


Washington
      University of Washington Medical Center, Seattle,  Washington,  98195,  United States; Recruiting
Joyce M. Engel, Ph.D.  206-598-0005    knowles@u.washington.edu 
Amy J. Hoffman, B.S.  206-616-9058    ajulian@u.washington.edu 
Joyce M. Engel, Ph.D., OT,  Principal Investigator

Study chairs or principal investigators

Joyce M. Engel, Ph.D.,  Principal Investigator,  University of Washington   

More Information

Study ID Numbers:  P01HD33988-00606A1
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  May 22, 2003
ClinicalTrials.gov Identifier:  NCT00061230
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 28, 2008



Page Updated: September 6, 2005
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