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

NCT ID: NCT00061230

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2006-03-31

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.

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.

Conditions

Cerebral Palsy

Keywords

Relaxation training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

biofeedback-monitored relaxation training

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Principal Investigators

Joyce M. Engel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Joyce M. Engel, Ph.D.

Role: primary

Amy J. Hoffman, B.S.

Role: backup

Other Identifiers

P01HD033988

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01HD33988-00606A1

Identifier Type: -

Identifier Source: org_study_id