Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00011024
First received: February 8, 2001
Last updated: August 17, 2006
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Spastic Cerebral Palsy
Procedure: Self Hypnosis
Procedure: Acupuncture
Procedure: Osteopathic Manipulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: September 1998
Estimated Study Completion Date: June 2004
Detailed Description:

The primary objective of this project is to develop and evaluate two different alternative or complementary medical modalities that have been used in children with cerebral palsy by practitioners in an attempt to decelerate the complications from the neurologic insult and resultant muscle imbalance. The specific aims are: 1) The development and incorporation of two alternative modalities (osteopathic manipulation and acupuncture) into available services in southern Arizona for individuals with cerebral palsy. 2) The evaluation of the uptake of and compliance with the two modalities in the clinical services for cerebral palsy. 3) Conduct pilot studies of each of the two modalities to determine their efficacy in decreasing the degree of muscle tension in children with spastic cerebral palsy.

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011024

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724-5035
Sponsors and Collaborators
Investigators
Principal Investigator: Burris Duncan University of Arizona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00011024     History of Changes
Other Study ID Numbers: P50 AT000008-01P3, P50 AT000008-01
Study First Received: February 8, 2001
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014