Clinical trial NCT06201520: The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome
Official title: The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome-A 3-arm, Randomized Sham Laser Acupuncture Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Carpal Tunnel Syndrome
Acupuncture
Laser Acupuncture
Keywords: Carpal Tunnel Syndrome
Acupuncture
Laser Acupuncture
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(CTS). However, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of CTS. A 3-arm, randomized controlled study in acupuncture, laser acupuncture study and sham laser acupuncture therapy was designed for patient with carpal tunnel syndrome. The Glabal symptom score (GSS), Boston Carpal Tunnel Questionnaire (BCTQ), neurophysiological study, morphological examination under ultrasonography will be evaluated before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.

Detailed description: The primary outcome will analyze the change of the Glabal symptom score (GSS) during intervention peroid. The secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.

Eligibility criteria: Inclusion Criteria:

* patients with mild to moderate carpal tunnel syndrome diagnosed by neurophysiological examination
* symptoms of carpal tunnel syndrome such as pain and numbness
* those who are willing to sign informed consent form for subjects

Exclusion Criteria:

* (1) Those who have not signed the informed consent
* (2) Patients diagnosed with severe carpal tunnel syndrome
* (3) Those who have had a history of surgery on their hands and palms
* (4) Space-occupying lesions such as tumors, bone spurs, synovial membrane tissue hypertrophy, etc.
* (5) People with a history of diabetes, rheumatoid arthritis, and hypothyroidism (HbA1c\>6.5, RF positive, Free T4, TSH in abnormal range)
* (6) Patients with end-stage renal disease
* (7) Pregnant and alcoholic patients
* (8) Polyneuropathy patients
* (9) Clinical symptoms with C6\~8 cervical radiculopathy
* (10) Those who are obviously infected
* (11) Those with a serious illness requiring hospitalization

Primary outcomes:
measure: The Boston Carpal Tunnel Questionnaire(BCTQ) changes
timeFrame: from baseline to 3 months
measure: Global symptoms score(GSS) changes
timeFrame: from baseline to 3 months
Secondary outcomes:
measure: compound motor action potential(CMAP)
timeFrame: from baseline to 3 months
measure: motor distal latency(MDL)
timeFrame: from baseline to 3 months
measure: Sensory nerve action potential (SNAP)
timeFrame: from baseline to 3 months
measure: sensory distal latency(SDL)
timeFrame: from baseline to 3 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Huang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maeda Y, Kim H, Kettner N, Kim J, Cina S, Malatesta C, Gerber J, McManus C, Ong-Sutherland R, Mezzacappa P, Libby A, Mawla I, Morse LR, Kaptchuk TJ, Audette J, Napadow V. Rewiring the primary somatosensory cortex in carpal tunnel syndrome with acupuncture. Brain. 2017 Apr 1;140(4):914-927. doi: 10.1093/brain/awx015.
citation: Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29.
citation: Chen CC, Wu YT, Su YC, Shen YP, Chen FP. Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial. Medicine (Baltimore). 2019 Jul;98(30):e16516. doi: 10.1097/MD.0000000000016516.