Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy

NCT00011024 | Completed Phase 2

• 2 other identifiers: P50AT000008-01P3P50AT000008-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to identify patients and families for inclusion in pilot studies of the three modalities. Patients and their families will be asked to participate in these studies. Our research group has done some preliminary work with the modality of hypnotherapy, but has no experience to date with the other two modalities. The idea to try relaxation techniques was generated by the observation that there is great variation in the degree to spasticity at different times in the same patient with CP. When queried, mothers responded that they were able to get their child to relax and decrease the tension in their muscles by stroking, talking softly, and/or by playing certain types of music. The availability of hypnosis and training in self-hypnosis was presented to several families of our patients. Their understanding and acceptance of this alternate therapy was gratifying. The results of this therapy have been promising and have encouraged us to proceed with this modality and to consider making other nonconventional modalities available to our patients. We hypothesize that at least one of the two modalities will be accepted readily by patients with CP and their families, and with their acceptance compliance with the method chosen will be at levels of 80 percent or more.

Conditions

Spastic Cerebral Palsy

Interventions

Self Hypnosis PROCEDURE

Acupuncture PROCEDURE

Osteopathic Manipulation PROCEDURE

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with a diagnosis of spastic CP who are between 48 months and 21 years of age.
• For the hypnotherapy-control arm the children must have a cognitive level sufficient to allow them to visualize and enter into trance.
• The cognitive level criteria will not apply to the manipulation-acupuncture-control arm of the study.
• No child will be excluded on the basis of gender, race or culture.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724-5035, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Hypnosis; Acupuncture Therapy; Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Musculoskeletal Manipulations; Physical Therapy Modalities; Rehabilitation

Study Officials

• Burris Duncan

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 8, 2001
• First Posted: February 9, 2001
• Study Start: September 1, 1998
• Study Completion: June 1, 2004
• Last Updated: August 18, 2006

Record last verified: 2006-08

Locations

US (1)