A multicenter, randomized controlled trial of massage in children with pediatric cerebral palsy

Abstract

Background: Cerebral palsy is 1 of the diseases critically affecting the health of children. The spasmodic type is the most common, characterized by the increased muscular tension. It often leads to lifelong disability, bringing a heavy economic burden to families and society. As a key treatment in traditional Chinese medicine, pediatric massage has a significant clinical effect on cerebral palsy in children; however, high-quality randomized controlled studies are lacking. The main objective of this study was to evaluate the efficacy of pediatric massage for children with spastic cerebral palsy. Methods/Design: The study will be a multicenter, single-blinded, randomized-controlled pilot trial. During the period from June 2019 to December 2020, 182 children with spastic cerebral palsy will be randomly divided into experimental and control groups in a 1:1 ratio. The experimental group will undergo the modified selective spinal massage method combined with the basic rehabilitation treatment, while only the basic rehabilitation treatment would be performed for the control group. The intervention period of the study will last 12 weeks, 5 days weekly on weekdays. The primary outcomes include a modified Ashworth scale assessment and gross motor function test. The secondary outcomes include the 4-diagnostic scale of Chinese medicine and children's intelligence. The observation index will be measured during the complete 12 weeks duration after the treatment of the child, that is, before treatment, after 4 weeks of treatment, after 8 weeks, and after 12 weeks of treatment. Discussion: This study aims to evaluate the efficacy of pediatric massage on children with spastic cerebral palsy; if the outcome is positive, it can provide a reference for the further promotion and application of pediatric massage in the treatment of spastic cerebral palsy. Trial registration: Chinese ClinicalTrials.gov, ID: ChiCTR1900021666. Acupuncture-Moxibustion Clinical Trial Registry, AMCTR: (AMCTR-IPR-19000260) Registered on 04 March 2019.

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement

“…The child will be placed in the supine position; the doctor will stand on the head side, opening the Tianmen 30 times, separate‐pushing the Kangong 30 times, separate‐pushing Ying Xiang (LI20) 30 times, kneading Taiyang (EX‐HN5) for 1 min, and grasping Jianjing (GB21) 3 to 5 times (Fig. 2).” 63 …”

“…Skin lesions and rashes are common side effects of massage. Once the AEs occur during the treatment, the time and severity of the treatment will be recorded in detail, the cause will be analysed, and the correlation between the AE and trial will be evaluated.” 63 “Expression of worsening symptoms during the study period, such as increasing pain intensity, swelling, and bruises, in which case a referral to conventional medicine would be given.” 83 …”

“…Skin lesions and rashes are common side effects of massage. Once the AEs occur during the treatment, the time and severity of the treatment will be recorded in detail, the cause will be analysed, and the correlation between the AE and trial will be evaluated.” 63 …”

Experience of parents in delivering pediatric tuina to children with symptoms of attention deficit hyperactivity disorder during the COVID-19 pandemic: qualitative findings from focus group interviews

“…Pediatric tuina, also called pediatric anmo or traditional Chinese medicine (TCM) pediatric massage, is a special massage therapy for infants and children. Previous studies have attempted to explore the effects of pediatric tuina on numerous clinical conditions and diseases [ 11 ], such as diarrhea [ 12 ], anorexia [ 13 ], torticollis [ 14 ], cerebral palsy [ 15 ], scleroderma [ 16 ], constipation [ 17 ], infantile malnutrition [ 18 ], and fever [ 19 ] and in the promotion of the growth and development of healthy children in China [ 20 ]. Pediatric tunia is an external therapy involving the stimulation of specific areas or acupoints of the body through various manipulation techniques, such as pushing, kneading, pressing, rotating, nipping, circular, and pounding [ 20 , 21 ].…”

Parents’ experience of delivering pediatric tuina to children with attention deficit hyperactivity disorder symptoms: qualitative findings from focus group interviews

“…It is an external therapy to stimulate speci c areas or acupoints of the body through various manipulation techniques, such as pushing, kneading, pressing, rotating, nipping, circular, ponding, and so forth (15,16). Previous studies have suggested that pediatric tuina may have bene cial effects on many clinical conditions and diseases (17), such as diarrhea (18), anorexia (19), torticollis (20), cerebral palsy (21), scleroderma (22), constipation (23), infantile malnutrition (24), and fever (25). Besides, tuina has been widely used to promote the growth and development of healthy children in the Chinese culture (15).…”