Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome

Institutional Review Board of Kuang Tien General Hospital

Sponsors

Commanditaire principal: Kuang Tien General Hospital

La source Kuang Tien General Hospital
Bref résumé

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.

Description détaillée

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)

Situation globale Not yet recruiting
Date de début 2021-04-10
Date d'achèvement 2021-10-20
Date d'achèvement principale 2021-09-20
Phase N/A
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Global symptom score Change from Baseline GSS at 2 weeks
Global symptom score Change from Baseline GSS at 4 weeks
Résultat secondaire
Mesure Plage de temps
Nerve conduction studies Change from Baseline nerve conduction studies (NCS) at 4 weeks
Inscription 150
État
Intervention

Type d'intervention: Device

Nom de l'intervention: laser acupuncture

La description: 400 mW, near-infrared, continuous wavelength, 810 nm. about 24J/cm2

Étiquette du groupe d'armements: Laser Acupuncture Group

Autre nom: RJ-LASER, Germany

Type d'intervention: Other

Nom de l'intervention: acupuncture

La description: Needle type: C&G, gauge and size: 0.25x40mm

Étiquette du groupe d'armements: Manual Acupuncture Group

Type d'intervention: Device

Nom de l'intervention: Sham laser acupuncture

La description: This laser pen is the same device with a red light was pasted on the acu-points in the same way, using the same protocol as for the active laser stimulation, but the laser apparatus was not switched on.

Étiquette du groupe d'armements: Sham Laser Acupuncture Group

Autre nom: RJ-LASER, Germany

Admissibilité

Critères:

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

Le sexe: All

Âge minimum: 20 Years

Âge maximum: 65 Years

Volontaires en santé: No

Officiel général
Nom de famille Rôle Affiliation
Chun-Pai Yang, PhD Principal Investigator Kuang Tien Genreal Hospital
Contact général

Nom de famille: LI-FENG LIN, Bachelor

Téléphone: +88642662-5111

Téléphone ext.: 3109

Email: [email protected]

Date de vérification

2021-03-01

Partie responsable

Type: Principal Investigator

Affiliation des enquêteurs: Kuang Tien General Hospital

Nom complet de l'enquêteur: Li-Feng Lin

Titre d'enquêteur: TCM department

Mots clés
A un accès étendu No
Parcourir l'état
Nombre d'armes 3
Groupe d'armes

Étiquette: Laser Acupuncture Group

Type: Experimental

La description: Acupuncture point: PC-6 and PC-7 laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk)

Étiquette: Manual Acupuncture Group

Type: Active Comparator

La description: Acupuncture point: PC-6 and PC-7 Responses elicited: de qi sensation Manual: twirling with lifting-thrusting method stimulation Needles retained for 30 min Needle type: C&G, gauge and size: 0.25x40mm

Étiquette: Sham Laser Acupuncture Group

Type: Sham Comparator

La description: Acupuncture point: PC-6 and PC-7 Sham laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk)

Données patient No
Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Parallel Assignment

Description du modèle d'intervention: The recruited patients were randomly divided into two groups of ''Laser Acupuncture Group'' and ''Manual Acupuncture Group"

Objectif principal: Treatment

Masquage: Single (Outcomes Assessor)

La source: ClinicalTrials.gov

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