The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome

Not Applicable

• Conditions: Acupuncture; Laser Acupuncture; Carpal Tunnel Syndrome
• Interventions: Device: laser acupuncture; Device: sham laser acupuncture; Procedure: manual acupuncture; Device: wrist splint

• Registration Number: NCT06201520
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-08-17
• Status Verified: 2023-12
• Primary Completion: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLA group (sham laser acupuncture group)	wrist splint	sham laser acupuncture group is designed with the same acupoints selection and no energy output
LA group (laser acupuncture group)	laser acupuncture	laser acupuncture gruoup with LaserPen, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; Nogier C frequency for 4 J each points The acupoints selection is the same as the MA group.
LA group (laser acupuncture group)	wrist splint	laser acupuncture gruoup with LaserPen, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; Nogier C frequency for 4 J each points The acupoints selection is the same as the MA group.
SLA group (sham laser acupuncture group)	sham laser acupuncture	sham laser acupuncture group is designed with the same acupoints selection and no energy output
MA group (manual acupuncture group)	manual acupuncture	Acupunctue Needle: 1 inch- 32 gauge（0.3x25 mm）for 20 min after De-qi Acupoints selection: PC4\[Ximen\], PC6\[Neiguan\], PC7\[Daling\], PC8\[Laogong\], HT2\[Qingling\], HT7\[Shenmen\], HT8\[Shaofu\], LU9\[Taiyuan\], LI11\[Quchi\]
MA group (manual acupuncture group)	wrist splint	Acupunctue Needle: 1 inch- 32 gauge（0.3x25 mm）for 20 min after De-qi Acupoints selection: PC4\[Ximen\], PC6\[Neiguan\], PC7\[Daling\], PC8\[Laogong\], HT2\[Qingling\], HT7\[Shenmen\], HT8\[Shaofu\], LU9\[Taiyuan\], LI11\[Quchi\]

Primary Outcome Measures

Name	Time	Method
The Boston Carpal Tunnel Questionnaire(BCTQ) changes	from baseline to 3 months	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.
Global symptoms score(GSS) changes	from baseline to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Sensory nerve action potential (SNAP)	from baseline to 3 months	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).
compound motor action potential(CMAP)	from baseline to 3 months	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).
sensory distal latency(SDL)	from baseline to 3 months	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).
motor distal latency(MDL)	from baseline to 3 months	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).

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan