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Relaxation Training to Decrease Pain and Improve Function in Adolescents With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT00061230
Recruitment Status : Unknown
Verified April 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : May 23, 2003
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cerebral Palsy Behavioral: biofeedback-monitored relaxation training

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Efficacy of Relaxation Training
Study Start Date : March 2003
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061230

United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Joyce M. Engel, Ph.D.    206-598-0005    knowles@u.washington.edu   
Contact: Amy J. Hoffman, B.S.    206-616-9058    ajulian@u.washington.edu   
Principal Investigator: Joyce M. Engel, Ph.D., OT         
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Joyce M. Engel, Ph.D. University of Washington
More Information

ClinicalTrials.gov Identifier: NCT00061230     History of Changes
Other Study ID Numbers: P01HD33988-00606A1
First Posted: May 23, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Relaxation training

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases