aser acupuncture for carpal tunnel syndrome: A randomized controlled trial using low-level laser interventio
- Conditions
- carpal tunnel syndromeAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12613001065785
- Lead Sponsor
- Kaung-Tien general hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 90
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method global symptom score (GSS) <br>[baseline and 2 and 4 weeks and 1 year later];Primary outcome measure was the difference in modified GSS between the verum and placebo group. This scale has been used to evaluate treatment responses in various previous studies.This assessment was to rate clinical symptoms from 0 (no symptoms) to 10 (very severe symptoms) in the following five symptom categories: pain, numbness, tingling, weakness/clumsiness, and nocturnal awakening. Each patient was directly questioned, and each score was based on the patient’s subjective answers. Therefore, the maximum score was 50 (most severe symptoms) and the minimum score was 0 (absence of symptoms). To ensure consistency, the evaluating physician who scored the main outcome measure, GSS, was the same person on each occasion for each patient and was blinded to the type of treatment. Patients completed standard questionnaires at baseline and 2 and 4 weeks later. [baseline and 2 and 4 weeks and 1 year later]
- Secondary Outcome Measures
Name Time Method Secondary outcomes measures were change in GSS reduction and all parameters of nerve conduction study (NCS) at different time phases compared to baseline and in comparison of verum laser acupuncture with placebo laser acupuncture. We defined a reduction of GSS more than 50% as good improvement, 30-50% as moderate improvement, and less than 30%, being lost to follow-up, showing APB muscle wasting, or receiving surgery or other conservative treatment as treatment failure for secondary outcome measures. [nerve conduction studies (NCS) at baseline, 4 weeks and 12 months later<br>]