Clinical trial NCT00061230: Relaxation Training to Decrease Pain and Improve Function in Adolescents With Cerebral Palsy
Official title: Efficacy of Relaxation Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Relaxation training
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Joyce M. Engel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: