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.
The primary outcome will analyze the change of the Glabal symptom score (GSS) during intervention peroid. The secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
manual acupuncture
laser acupuncture therapy
sham laser acupuncture
wear wrist splint at night
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
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.
Time frame: 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.
Time frame: from baseline to 3 months
compound motor action potential(CMAP)
Nerve Electrophysiological examination of median nerve.The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including compound motor action potential(CMAP). The unit of CMAP is millivolt (mV).
Time frame: from baseline to 3 months
motor distal latency(MDL)
Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including motor distal latency(MDL). The unit of motor distal latency is millisecond (ms).
Time frame: from baseline to 3 months
Sensory nerve action potential (SNAP)
Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including Sensory nerve action potential (SNAP). The unit of SNAP is also millivolt (mV).
Time frame: from baseline to 3 months
sensory distal latency(SDL)
Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including sensory distal latency(SDL). The unit of sensory distal latency is also millisecond (ms).
Time frame: from baseline to 3 months
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