None listed
Conditions
Brief summary
Objectives: To investigate the efficacy of laser acupuncture compared with placebo laser acupuncture treatment in patients with mild-to-moderate carpal tunnel syndrome (CTS) as measured by subjective symptoms assessment and objective changes in nerve conduction studies (NCS) in a randomized, controlled study. Methods: A total of 84 consecutive and prospective CTS patients confirmed by NCS were enrolled in the study. The CTS patients were randomly divided into 2 treatment arms: (1) Laser acupuncture administered in traditional Chinese acu-points (PC -7 (Daling), PC-6 (Neiguan)) on the affected side once a a day, 5 times a week, for 4 weeks (n=43), and (2) Placebo laser acupuncture administered by the same device with same protocol as for true laser stimulation, but the laser apparatus was not switched on (n=41). A validated global symptom score (GSS) as a subjective measurement was used to rate the 5 major symptoms (pain, numbness, paresthesia, weakness/clumsiness, and nocturnal awakening) on a scale from 0 (no symptoms) to 10 (very severe). Patients completed GSS at baseline and 2 and 4 weeks later. The changes in GSS were analyzed to evaluate the subjective symptoms improvement for primary outcome. NCS were performed at baseline and repeated at the end of the study to assess objective improvement for secondary outcome. All main analyses used intent-to-treat.
Interventions
laser acupuncture treatment indicates using Low level laser (class IIIb lasers, 400mw, near infrared, continuous wavelength, 810nm, LaserPenR, RJ-LASER, Germany) in traditional Chinese acu-points (PC -7 (Daling), PC-6 (Neiguan)) on the affected side. Laser acupuncture consisted of once per day for five consecutive days followed by a two-day break with a total of 20 sessions in four weeks period. Each stimulation was performed in the continuous wave mode for 1 minute. The energy transferred to t
laser acupuncture treatment indicates using Low level laser (class IIIb lasers, 400mw, near infrared, continuous wavelength, 810nm, LaserPenR, RJ-LASER, Germany) in traditional Chinese acu-points (PC -7 (Daling), PC-6 (Neiguan)) on the affected side. Laser acupuncture consisted of once per day for five consecutive days followed by a two-day break with a total of 20 sessions in four weeks period. Each stimulation was performed in the continuous wave mode for 1 minute. The energy transferred to the skin in a treatment of 1 minute was up to approximately 24 J/cm2.
Sponsors
Kaung-Tien general hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for treatment naïve patients, aged from 20 to 65, enrolled in this study were based on a combination of clinical and electrodiagnosis of mild or moderate idiopathic CTS. The CTS diagnosis was based on the presence of at least one of the following symptoms: 1) pain, numbness or paresthesia in the median nerve distribution; 2) precipitation of these sensory complaints by forceful or repetitive hand use which could be relieved by resting, rubbing and shaking the hands; and 3) awakening from sleep due to such sensory symptoms. The diagnosis was often supported by a positive Tinel’s sign or Phalen’s test. All patients with clinically diagnosed CTS demonstrated median neuropathy at the wrist, confirmed by the presence of one or more of the following standard electrophysiological criteria: 1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB) (abnormal = 4.7 ms; wrist to APB, 8 cm); 2) prolonged anti-dromic distal sensory latency (DSL) to the second digit (abnormal = 3.1 ms; wrist to index finger, 14 cm); and 3) prolonged anti-dromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal < 45 m/s). In our study, mild CTS referred to patients with decreased conduction velocity over the palm-wrist segment and delayed DSL, with normal median sensory nerve action potential (SNAP) amplitude and compound muscle action potential (CMAP) amplitude of the APB. Moderate CTS referred to patients with abnormally delayed DML and DSL with either decreased median SNAP amplitude or decreased CMAP amplitude of the APB muscle. Thus, CTS patients with the presence of either fibrillation potentials or re-innervation on needle electromyography (EMG) in the APB were considered severe CTS.
Exclusion criteria
Patients were excluded if any of the following were present: (1) Symptoms occurring less than three 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 electrophysiological 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 were documented as underlying causes for CTS; or (5) Cognitive impairment interfering with the subject’s ability to follow instructions and describe symptoms.
Outcome results
None listed