The trial’s design, “Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial,” was recently published in the journal Trials.
Acupuncture is an ancient healing technique of traditional Chinese medicine that has been practiced in China for more than 3,000 years to treat a variety of disorders. It involves the strategic placement of thin sterile needles through a person’s skin at particular points on the body.
While in traditional Chinese medicine, acupuncture is believed to re-balance a person’s energy flow to improve health, acupuncture in Western medicine is thought to stimulate the nervous system by releasing chemical signals to the muscles, spinal cord, and brain.
In China, several approaches to scalp acupuncture (needles placed on the scalp) have been widely used in combination with conventional therapy to treat motor dysfunction in these children. Jiao’s scalp acupuncture — which combines a modern understanding of the brain’s anatomy and function with traditional acupuncture techniques — targets the motor area of the brain and is the most commonly used approach.
“However, the exclusive effectiveness of the motor area of Jiao’s scalp acupuncture treatment on motor dysfunction in children with CP is not well documented,” the researchers wrote, adding that “no high-quality randomized controlled trials on scalp acupuncture have been published.”
Now, the Children’s Hospital of Fudan University, in Shanghai, China, has launched a randomized, controlled clinical trial (NCT03921281) to evaluate whether adding Jiao’s scalp acupuncture to standard rehabilitation significantly improves motor function in children with CP.
Researchers aim to recruit 100 children with spastic CP, ages 1 to 6, at four hospitals in Shanghai. Participants will be randomly assigned to receive either a combination of Jiao’s scalp acupuncture and routine rehabilitation treatment, or routine rehabilitation alone, three times a week for 12 weeks.
Acupuncture treatment will include Jiao’s motor area as the main acupoint and a secondary acupoint called Si shencong (EX-HN1). Both acupuncture and rehabilitation sessions will have a duration of approximately one hour. The use of Chinese herbal or approved medicines will be prohibited during the study.
After treatment, children will be followed-up for an additional 12-week period, in which they will continue standard rehabilitation and decide whether to continue acupuncture treatment.
The study’s primary goal is to assess changes in motor function through the Gross Motor Function Measure — which assesses overall motor function — and the Fine Motor Function Measure, which assesses upper limb motor skills.
Participants will be evaluated through these measures at the start of the study, during treatment (at four, eight, and 12 weeks), and at the end of the follow-up period (24 weeks). Safety will also be assessed through the occurrence of adverse events.
The trial’s recruitment process began in March 2019, and it is expected to be completed by the end of 2021. More information on contacts and enrollment locations can be found here.