Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy
Primary Purpose
Spastic Cerebral Palsy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self Hypnosis
Acupuncture
Osteopathic Manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy
Eligibility 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.
Sites / Locations
- University of Arizona
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00011024
First Posted
February 8, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00011024
Brief Title
Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy
Official Title
Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Self Hypnosis
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burris Duncan
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5035
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prospective Studies of the Use of Self Hypnosis, Acupuncture and Osteopathic Manipulation on Muscle Tension in Children With Spastic Cerebral Palsy
We'll reach out to this number within 24 hrs