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Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial.

ABSTRACT: INTRODUCTION:Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy that causes hand discomfort and work disability. Since no satisfactory conventional treatments for mild to moderate CTS exist, we apply complementary alternative medicine (CAM) to this problem. Laser acupuncture (LA), a new, non-invasive therapy which uses low-level-laser therapy (LLLT) in acupuncture could help to manage CTS. However, only one small randomized, double-blind and crossover trial had been conducted, which is not enough to provide an evidence-based assessment of the effects of LA on CTS. OBJECTIVES:The aim of this study protocol is to investigate the efficacy of LA therapy on patients with mild to moderate CTS through sonography of the median nerve and offer clear parameters of LLLT. METHODS:This study protocol is a prospective double-blind randomized controlled trial. Forty subjects aged 20 to 80 years old and diagnosed as having mild to moderate CTS will be randomly assigned to the intervention group (real LA, 3-sessions a week for 2 weeks) and control group (sham LA, 3-sessions a week for 2 weeks). All subjects will be asked to wear night splints as the fundamental management approach. The laser parameters will include a wavelength of 808?nm, power output of 300 mW and power density of 300 mW/mm, with ten seconds of treatment for each acupuncture point (PC4, PC6, PC7, PC8, LI4, LI10, LI11, HT3, HT7, and LU10). Sham LA treatment will be applied without any laser power output. The primary outcome will be based the Boston Carpal Tunnel Syndrome Questionnaire and secondary outcomes included a visual analog scale, cross sectional area of median nerve by sonography and electrophysiological test before interventions and after 2, 4, 8, 12 weeks postintervention. TRIAL REGISTRATION:ClinicalTrials.gov (Identifier: NCT03580265).

SUBMITTER: Chen CC

PROVIDER: S-EPMC6709042 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial.

Chen Chuan-Chih CC Wu Yung-Tsan YT Su Yu-Chi YC Shen Yu-Ping YP Chen Fang-Pey FP

Medicine 20190701 30

<h4>Introduction</h4>Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy that causes hand discomfort and work disability. Since no satisfactory conventional treatments for mild to moderate CTS exist, we apply complementary alternative medicine (CAM) to this problem. Laser acupuncture (LA), a new, non-invasive therapy which uses low-level-laser therapy (LLLT) in acupuncture could help to manage CTS. However, only one small randomized, double-blind and crossover trial had been co ...[more]

PMID: 31348263

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Project description:Carpal tunnel syndrome is the most common entrapment neuropathy, affecting the median nerve at the wrist. Acupuncture is a minimally-invasive and conservative therapeutic option, and while rooted in a complex practice ritual, acupuncture overlaps significantly with many conventional peripherally-focused neuromodulatory therapies. However, the neurophysiological mechanisms by which acupuncture impacts accepted subjective/psychological and objective/physiological outcomes are not well understood. Eligible patients (n = 80, 65 female, age: 49.3 ± 8.6 years) were enrolled and randomized into three intervention arms: (i) verum electro-acupuncture 'local' to the more affected hand; (ii) verum electro-acupuncture at 'distal' body sites, near the ankle contralesional to the more affected hand; and (iii) local sham electro-acupuncture using non-penetrating placebo needles. Acupuncture therapy was provided for 16 sessions over 8 weeks. Boston Carpal Tunnel Syndrome Questionnaire assessed pain and paraesthesia symptoms at baseline, following therapy and at 3-month follow-up. Nerve conduction studies assessing median nerve sensory latency and brain imaging data were acquired at baseline and following therapy. Functional magnetic resonance imaging assessed somatotopy in the primary somatosensory cortex using vibrotactile stimulation over three digits (2, 3 and 5). While all three acupuncture interventions reduced symptom severity, verum (local and distal) acupuncture was superior to sham in producing improvements in neurophysiological outcomes, both local to the wrist (i.e. median sensory nerve conduction latency) and in the brain (i.e. digit 2/3 cortical separation distance). Moreover, greater improvement in second/third interdigit cortical separation distance following verum acupuncture predicted sustained improvements in symptom severity at 3-month follow-up. We further explored potential differential mechanisms of local versus distal acupuncture using diffusion tensor imaging of white matter microstructure adjacent to the primary somatosensory cortex. Compared to healthy adults (n = 34, 28 female, 49.7 ± 9.9 years old), patients with carpal tunnel syndrome demonstrated increased fractional anisotropy in several regions and, for these regions we found that improvement in median nerve latency was associated with reduction of fractional anisotropy near (i) contralesional hand area following verum, but not sham, acupuncture; (ii) ipsilesional hand area following local, but not distal or sham, acupuncture; and (iii) ipsilesional leg area following distal, but not local or sham, acupuncture. As these primary somatosensory cortex subregions are distinctly targeted by local versus distal acupuncture electrostimulation, acupuncture at local versus distal sites may improve median nerve function at the wrist by somatotopically distinct neuroplasticity in the primary somatosensory cortex following therapy. Our study further suggests that improvements in primary somatosensory cortex somatotopy can predict long-term clinical outcomes for carpal tunnel syndrome.

Project description:Patients with idiopathic carpal tunnel syndrome (CTS) are commonly treated with steroid injection into or proximal to the carpal tunnel. However, evidence for its efficacy beyond one month has not been established in randomized placebo-controlled trials. The primary aim of this randomized trial is to assess the efficacy of steroid injection into the carpal tunnel in relieving symptoms of CTS in patients with symptoms of such severity to warrant surgical treatment but have not been treated with steroid injection.The study is a randomized double-blind placebo-controlled trial. Patients referred to one orthopedic department because of CTS are screened. Eligibility criteria are age 18 to 70 years, clinical diagnosis of primary idiopathic CTS and abnormal nerve conduction tests or clinical diagnosis made independently by two orthopedic surgeons, failed treatment with wrist splinting, symptom severity of such magnitude that the patient is willing to undergo surgery, no severe sensory loss or thenar muscle atrophy, and no previous steroid injection for CTS. A total of 120 patients will be randomized to injection of 80 mg Methylprednisolone, 40 mg Methylprednisolone, or normal saline, each also containing 10 mg Lidocaine. Evaluation at baseline and at 5, 10, 24 and 52 weeks after injection includes validated questionnaires (CTS symptom severity scale, QuickDASH and SF-6D), adverse events, physical examination by a blinded assessor, and nerve conduction tests. The primary outcome measures are change in the CTS symptom severity score at 10 weeks and the rate of surgery at 52 weeks. The secondary outcome measures are the score change in the CTS symptom severity scale at 52 weeks, time to surgery, and change in QuickDASH and SF-6D scores and patient satisfaction at 10 and 52 weeks. The primary analysis will be carried out using mixed model analysis of repeated measures.This paper describes the rationale and design of a double-blind, randomized placebo-controlled trial that aims to determine the efficacy of two different doses of steroid injected into the carpal tunnel in patients with moderately severe idiopathic CTS.Clinicaltrials.gov identifier NCT00806871.

Dataset Information

Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial.

Publications

Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial.

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