Acupuncture as Complementary Therapy for Cerebral Palsy

NCT00221247 | Completed Phase 2

• 3 other identifiers: HSC #04-126ADCRC: No. 9-039Commission contract No.9001
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 2

Brief Summary

Background: Cerebral palsy (CP) is the most frequent cause of childhood disability in the US. Nevertheless, current standard of care for CP in the U.S. is to a large extent ineffective. The Chinese, on the other hand, claim to have an exceptionally high response rate with the administration of an integrated package of care that includes the combination of intense 'conventional' therapies and acupuncture. Despite numerous anecdotal reports, this claim has not yet been tested in a rigorous scientific way. Objective: To determine the effectiveness of acupuncture when used as an adjunct to intense 'conventional' physical, occupational, and hydro- therapies to improve function and quality of life in children with spastic CP. Hypotheses: (1) Adjunctive acupuncture therapy will improve the gross and fine motor function and the health related quality of life of children with spastic CP more than intense 'conventional' therapies alone. (2) The level of persistence of gross and fine motor function and health related quality of life achieved with adjunctive acupuncture administered in combination with intense 'conventional' therapies will be higher than those achieved with intense 'conventional' therapies alone. Design: A parallel, two-arm, prospective, evaluation-blind, pragmatic, non-inferiority, randomized controlled clinical trial (RCT). Setting: This international collaborative study will be conducted at two different localities: (1) At the Beijing Children's Hospital (BCH), where participants' recruitment, intervention therapies, videotape evaluation, and data collection will be done, and (2) At the University of Arizona, where scoring of the videotape evaluations and data analyses will be done, and from where logistic support will be provided to assure the scientific integrity of the study. Population: Approximately 100 children between the ages 1 and 6 years with spastic CP. Intervention: Concurrent administration of acupuncture with intense 'conventional' therapies at the outset of the study vs. sequential administration of both components. Outcomes: 'Gross Motor Function', 'Fine Motor Function', 'Range of Motion', 'Level of Motor Involvement', and 'Health-Related Quality of Life' measured at times 0,4,8,12,24,and 36 weeks. Evaluation: Independent blinded evaluation with respect to the type of the intervention and the stage of the therapeutic schedule done in the U.S. based on videotapes filmed in China. Data management: Web-based data center and intersite-networking infrastructure. Data analyses: Intention to treat analysis supplemented by linear mixed effects models with nested grouping factors. Significance and future directions: If the hypotheses are confirmed the study would lay the groundwork for future research, and impact clinical practice and health care policy as related to CP therapy.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; acupuncture

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy with acupuncture

Procedure: Acupuncture

Group 2

NO INTERVENTION

Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy without acupuncture

Interventions

Acupuncture PROCEDURE

acupuncture

Group 1

Eligibility Criteria

• Age: 12 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 12 and 72 months.
• Children with a diagnosis of spastic cerebral palsy (CP) or mixed type CP where spasticity is the dominant feature.

You may not qualify if:

• Age - Any child with CP who is younger than 12 months or older than 72 months.
• Etiology - Any damage to the CNS that either (a) is not static in nature, such as degenerative or progressive central nervous disorders, or (b) occurred after the first year of life, or (c) any child who has a phenotypic pattern suggesting a chromosomal abnormality (e.g., trisomy 13 or 18).
• Diagnosis - Children for whom the diagnosis of spastic CP or mixed-type CP with spasticity as the dominant feature cannot be established with absolute certainty, or children with dyskinetic CP. Rationale - To assure subject homogeneity, in cases in which there is disagreement between the physicians with respect to the diagnosis of a child, even if one of the physicians feels certain that a child has spastic CP, the children would be automatically excluded.
• Co-morbidities - Medical conditions, whether acute or chronic, for which acupuncture or intense 'conventional' therapies are considered contraindicated. Rationale - assuring participants' safety.
• Co-interventions - Any child receiving or scheduled to receive treatment(s) during the study period that may confound the results (e.g., an orthopedic or neurosurgical procedure, Botulinum toxin injections, a Baclofen pump or hyperbaric oxygen treatment). Rationale -To avoid a threat to causal inferences.
• Parallel participation in another CP clinical trial. Rationale - To avoid pragmatic and ethical issues that may arise as a result of a conflict of interests and limited resources.

Sponsors & Collaborators

• University of Arizona: lead
• Beijing Children's Hospital: collaborator

Study Sites (2)

The University of Arizona, Department of Pediatrics

Tucson, Arizona, 85724, United States

Location

Beijing Children's Hospital

Beijing, Beijing Municipality, 100045, China

Location

Related Publications (2)

• Duncan B, Shen K, Zou LP, Han TL, Lu ZL, Zheng H, Walsh M, Venker C, Su Y, Schnyer R, Caspi O. Evaluating intense rehabilitative therapies with and without acupuncture for children with cerebral palsy: a randomized controlled trial. Arch Phys Med Rehabil. 2012 May;93(5):808-15. doi: 10.1016/j.apmr.2011.12.009.

  PMID: 22541308 DERIVED

• Wu Y, Zou LP, Han TL, Zheng H, Caspi O, Wong V, Su Y, Shen KL. Randomized controlled trial of traditional Chinese medicine (acupuncture and tuina) in cerebral palsy: part 1--any increase in seizure in integrated acupuncture and rehabilitation group versus rehabilitation group? J Altern Complement Med. 2008 Oct;14(8):1005-9. doi: 10.1089/acm.2007.0756.

  PMID: 18990048 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Burris Duncan, M.D.

  The University of Arizona, Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics & Public Health

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

CN (1); US (1)