Acupuncture as Complementary Therapy for Cerebral Palsy

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.