The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome

NCT06201520 | Unknown DMC

• 1 other identifier: 201901768A3
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Acupuncture; Laser Acupuncture

Keywords

Carpal Tunnel Syndrome; Acupuncture; Laser Acupuncture

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• compound motor action potential(CMAP)

  from baseline to 3 months

• motor distal latency(MDL)

  from baseline to 3 months

• Sensory nerve action potential (SNAP)

  from baseline to 3 months

• sensory distal latency(SDL)

  from baseline to 3 months

Study Arms (3)

MA group (manual acupuncture group)

EXPERIMENTAL

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\[Quchi\]

Procedure: manual acupuncture; Device: wrist splint

LA group (laser acupuncture group)

EXPERIMENTAL

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.

Device: laser acupuncture; Device: wrist splint

SLA group (sham laser acupuncture group)

SHAM COMPARATOR

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

Device: sham laser acupuncture; Device: wrist splint

Interventions

manual acupuncture PROCEDURE

manual acupuncture

MA group (manual acupuncture group)

laser acupuncture DEVICE

laser acupuncture therapy

LA group (laser acupuncture group)

sham laser acupuncture DEVICE

sham laser acupuncture

SLA group (sham laser acupuncture group)

wrist splint DEVICE

wear wrist splint at night

LA group (laser acupuncture group); MA group (manual acupuncture group); SLA group (sham laser acupuncture group)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 28334999 BACKGROUND

• 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.

  PMID: 26433799 RESULT

• 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.

  PMID: 31348263 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Huang

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: January 11, 2024
• Study Start: May 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Locations

TW (1)