Clinical trial NCT04828239: Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome
Official title: Institutional Review Board of Kuang Tien General Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: laser acupuncture
Carpal Tunnel Syndrome
manual acupuncture
Lead sponsor: Kuang Tien General Hospital
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The recruited patients were randomly divided into two groups of ''Laser Acupuncture Group'' and ''Manual Acupuncture Group"
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTS) results from the entrapment neuropathy of median nerve at the wrist, and most cases are idiopathic. So far, there are many treatments were developed (Surgical decompression, local injection of steroids, Wrist splints) but they are not fully satisfactory, other treatment modalities need to be further evaluated.

Both Acupuncture and laser acupuncture treatments for CTS have been reported. However, those studies still lack associated evidence to evaluate the efficacy of acupuncture and laser acupuncture.

The object of the study is to investigate the efficacy of acupuncture compared with laser acupuncture in patients with mild-to-moderate carpal tunnel syndrome (CTS). Nerve conduction studies (NCS) and global symptom score (GSS) assessment will apply to measure objective changes in this randomized, controlled study.

Detailed description: Both manual acupuncture and laser acupuncture treatments for CTS have been reported.

Laser acupuncture (LA) is defined as the stimulation of traditional acupuncture points by using low-level intensity. Its a noninvasive treatment than acupuncture for those patients had the potential risk for infection or people involving pain or fear of needles. So far, previous studies still lack associated evidence about comparisons between laser acupuncture and manual acupuncture to evaluate their efficacy. So the investigators would like to compare the efficacy of acupuncture treatment with laser acupuncture (LA) treatment in patients with idiopathic, mild-to-moderate carpal tunnel syndrome (CTS)

Eligibility criteria: Inclusion Criteria:

CTS diagnosis was based on the presence of at least one of the following symptoms

1. numbness, tingling pain, or paresthesia in the median nerve distribution
2. precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand
3. nocturnal awakening by such sensory symptoms.
4. The diagnosis was often supported by a positive Tinel sign Confirmed by the presence of one or more of the following standard electrophysiologic criteria

(1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB) (abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode) (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms;stimulation over the wrist, 14 cm proximal to the active electrode) (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal \<45 m/s).9-

Exclusion Criteria:

1. Symptoms occurring less than 3 months before the study (to exclude patients who might have spontaneous resolution of symptoms)
2. severe CTS that had progressed to visible muscle atrophy
3. clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy
4. evidence of obvious underlying etiologic factors of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), and suspected malignancy or inflammation or autoimmune disease documented as underlying causes of CTS
5. cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms

Primary outcomes:
measure: Global symptom score
timeFrame: Change from Baseline GSS at 2 weeks
measure: Global symptom score
timeFrame: Change from Baseline GSS at 4 weeks
Secondary outcomes:
measure: Nerve conduction studies
timeFrame: Change from Baseline nerve conduction studies (NCS) at 4 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Kuang Tien Genreal Hospital
Study officials:
affiliation: Kuang Tien Genreal Hospital
name: Chun-Pai Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: