Zeng-Qiao Zhang1,2, Kun-Peng Li3, Jing He2, Li-Ming Jiang1,2, Wu Wang3,2, Xiao-Shen Hu2, Wei Feng4,5. 1. Department of orthopedic rehabilitation, the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 358 Datong Road, Shanghai, 200137, China. 2. School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China. 3. Department of Neurological Rehabilitation, the Second Rehabilitation Hospital of Shanghai, Shanghai, China. 4. Department of orthopedic rehabilitation, the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 358 Datong Road, Shanghai, 200137, China. fengweitg@yeah.net. 5. School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China. fengweitg@yeah.net.
Abstract
BACKGROUND: The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation have shown that fascial-point needling can effectively alleviate hand spasm immediately after stroke, but further evidence from large-sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial-point acupuncture on hand spasm after stroke. METHODS/ DESIGN: This multicenter randomized controlled trial will compare the efficacy of fascial-point acupuncture versus sham acupuncture and routine rehabilitation therapy in stroke patients with hand spasm. Patients will be randomized to undergo either the fascial-point acupuncture, the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indices are the remission of hand spasm and the duration of spasm remission. The second evaluation indices are the hand function of the affected limbs and the activities of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage. DISCUSSION: Our aim is to evaluate the efficacy of fascial-point acupuncture in relieving hand spasm after stroke. The results should provide more evidence for the clinical application of this therapy in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR1900022379. Registered on 9 April 2019.
RCT Entities:
BACKGROUND: The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation have shown that fascial-point needling can effectively alleviate hand spasm immediately after stroke, but further evidence from large-sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial-point acupuncture on hand spasm after stroke. METHODS/ DESIGN: This multicenter randomized controlled trial will compare the efficacy of fascial-point acupuncture versus sham acupuncture and routine rehabilitation therapy in strokepatients with hand spasm. Patients will be randomized to undergo either the fascial-point acupuncture, the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indices are the remission of hand spasm and the duration of spasm remission. The second evaluation indices are the hand function of the affected limbs and the activities of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage. DISCUSSION: Our aim is to evaluate the efficacy of fascial-point acupuncture in relieving hand spasm after stroke. The results should provide more evidence for the clinical application of this therapy in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR1900022379. Registered on 9 April 2019.
Entities:
Keywords:
Acupuncture; Fascia points; Spasm; Stroke