The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome-A 3-arm, Randomized Sham Laser Acupuncture Controlled Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06201520
• Other study ID #: 201901768A3
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: February 2024

Study information

• Verified date: December 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• manual acupuncture
manual acupuncture

Device:
• laser acupuncture
laser acupuncture therapy
• sham laser acupuncture
sham laser acupuncture
• wrist splint
wear wrist splint at night

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Boston Carpal Tunnel Questionnaire(BCTQ) changes	The Boston Carpal Tunnel Questionnaire(BCTQ) is a questionnaire for CTS patients, which has been used widely in the world. It contains two parts. One part is the symptom severity scale (BCTQsss) which contains eleven questions about symptom severity, and another part is the function severity scale (BCTQfss) contains eight questions about functional status evaluation. Each selection option includes 1~5 to present different degrees of severity ("5" is the most severe). The max of BCTQsss is 55 and the min is 11. The max of BCTQfss is 40 and the min is 8. The higher scores mean a worse outcome.	from baseline to 3 months
Primary	Global symptoms score(GSS) changes	GSS is a questionnaire to evaluate the severity of five symptoms, including pain, numbness, paresthesias, weakness/ clumsy, and nocturnal awakening for CTS patients.; The score of pain, numbness, and paresthesias according to the magnitude: from 0 (nil) to 10 (most severe).; The score for weakness/ clumsiness is according to the severity: 0 (none); 2(mild); 3(moderate); 4(severe); 5(very severe).; The score for nocturnal awakening is according to how many times awaked in one week: 0(never); 2(once or twice); 4(three or four times); 6(five to seven times); 8(eight to ten times); 10(more than ten times).; The total score added up forms the GSS score. The minimum score is 0, and the maximum score is 50. The higher scores mean a worse outcome.	from baseline to 3 months
Secondary	compound motor action potential(CMAP)	Nerve Electrophysiological examination of median nerve.The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including compound motor action potential(CMAP).; The unit of CMAP is millivolt (mV).	from baseline to 3 months
Secondary	motor distal latency(MDL)	Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including motor distal latency(MDL).; The unit of motor distal latency is millisecond (ms).	from baseline to 3 months
Secondary	Sensory nerve action potential (SNAP)	Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including Sensory nerve action potential (SNAP).; The unit of SNAP is also millivolt (mV).	from baseline to 3 months
Secondary	sensory distal latency(SDL)	Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including sensory distal latency(SDL).; The unit of sensory distal latency is also millisecond (ms).	from baseline to 3 months