The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome

Chang Gung Medical Foundation

Status: Invitation-only

Conditions: Acupuncture; Carpal Tunnel Syndrome; Laser Acupuncture

Treatments: Device: laser acupuncture; Device: sham laser acupuncture; Procedure: manual acupuncture; Device: wrist splint

Study type: Interventional

Funder types: Other

Identifiers

NCT06201520

201901768A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

MA group (manual acupuncture group)

Experimental group

Description:

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\[Quchi\]

Treatment:

Procedure: manual acupuncture

Device: wrist splint

LA group (laser acupuncture group)

Experimental group

Description:

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.

Treatment:

Device: laser acupuncture

Device: wrist splint

SLA group (sham laser acupuncture group)

Sham Comparator group

Description:

sham laser acupuncture group is designed with the same acupoints selection and no energy output

Treatment:

Device: sham laser acupuncture

Device: wrist splint