Acupuncture as Complementary Therapy for Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The proposed study is a parallel, two-arm, prospective, evaluation-blind, randomized
      controlled clinical trial (RCT). It has been designed to examine 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 cerebral
      palsy (CP). This international collaborative study will be conducted at two locations: (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.
      The specific aims of the proposed study are:

      Specific Aim #1: To compare the outcomes achieved after 12 weeks of acupuncture administered
      concurrently with intense 'conventional' therapies (physical, occupational, and
      hydro-therapies) to those achieved with intense 'conventional' therapies alone in the
      management of children with spastic CP.

      Hypothesis #1: Adjunctive acupuncture administered concurrently with intense 'conventional'
      therapies 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, as
      determined by standardized measures (see pgs. 20-22).

      Specific Aim #2: To examine the short and intermediate term persistence of any changes in the
      outcomes achieved with acupuncture administered concurrently with intense 'conventional'
      therapies (physical, occupational, and hydro-therapies) to those achieved with intense
      'conventional' therapies alone in the management of children with spastic CP.

      Hypothesis #2: When compared three months after termination of therapy, the level of gross
      and fine motor function and health related quality of life achieved with acupuncture
      administered concurrently with intense 'conventional' therapies (physical, occupational, and
      hydro-therapies) will be higher than those achieved with intense 'conventional' therapies
      alone.

      Taking advantage of the fact that ethically all the Chinese children with spastic CP who
      would participate in this study ought to receive acupuncture at one point or another as part
      of their care (see pg. 12) we propose, as a secondary aim, to begin to examine whether the
      timing of the administration of adjunctive acupuncture in relation to the timing of the
      administration of intense 'conventional' therapies has any effect on the outcomes, as
      determined by standardized measures.

      It is to be emphasized, that this study does not aim primarily at testing sequence effects
      related to the most appropriate timing of administration of adjunctive acupuncture in the
      treatment of children with spastic CP since a) it must first be examined whether acupuncture
      has any effect at all in this population, and b) testing sequence effects would greatly
      complicate the design of such a study to a point where it may render it not feasible. Rather,
      we are simply taking advantage of the ethical obligation to provide every participant with
      acupuncture at some point in time (not because it is proven from an efficacy standpoint but
      because it is the standard of care in China) so as to begin to explore any potential temporal
      relationships between administration of adjunctive acupuncture and outcomes. For example,
      since Group 1 would receive adjunctive acupuncture concurrently with intense 'conventional'
      therapies whereas Group 2 would receive adjunctive acupuncture therapy subsequently to
      intense 'conventional' therapies (see Figure 1 on pg. 11), the design allows to begin to
      explore whether adjunctive acupuncture administered subsequent to intense 'conventional'
      therapies may have a booster effect on the degree of gross and fine motor function and health
      related quality of life of children with spastic CP.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; acupuncture