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

Cerebral Palsy Clinical Trial

Official title:

Efficacy of Relaxation Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00061230
• Other study ID #: P01HD33988-00606A1
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2003
• Last updated: June 23, 2005
• Start date: March 2003
• Est. completion date: March 2006

Study information

• Verified date: April 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• biofeedback-monitored relaxation training

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

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

Country where clinical trial is conducted

United States,