An interventional study of low level laser treatment and High intensity laser treatment in Carpal Tunnel Syndrome, Electromyography and Low-Level Laser Therapy, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
Carpal tunnel syndrome is the most common entrapment neuropathy and is frequently encountered in clinical practice. Although there is no standard protocol for its treatment, conservative treatment methods are preferred. In our study, we aimed to clinically compare the efficacy of high and low intensity laser treatments in patients with carpal tunnel syndrome. By using methods such as electromyography and ultrasound, we aimed to provide a more objective evaluation
Our study was designed as a prospective, randomised, controlled, single-centre trial. A total of 63 patients aged 18-65 years with electrophysiologically diagnosed mild to moderate carpal tunnel syndrome and 114 hands were included in the study. Patients were divided into 3 groups. Patients in all three groups wore a neutral wrist splint of appropriate size. The second group included patients who additionally received low level laser therapy (LLLT), and the third group included patients who additionally received high intensity laser therapy (HILT). All groups underwent clinical, electrophysiological, and ultrasonographic examinations at the beginning of the treatment, at 1st month, and at 3rd month after the treatment.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 140 are open to participants now.
This study's enrollment of 108 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
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Exclusion Criteria:
wrist splints of an appropriate size in a neutral position for at least 8 hours at night for 3 months
Other: wrist splint
* wrist splints of an appropriate size in a neutral position for at least 8 hours at night for 3 months * received an additional LLLT
Device: low level laser treatment
* wrist splints of an appropriate size in a neutral position for at least 8 hours at night for 3 months * received an additional HILT
Device: High intensity laser treatment
The laser device from Mectronic Medicale was used for LLLT. LASER treatments were to be performed every other day for a total of 10 sessions.
The laser device from HIRO TT (ASA, Italy) was used for HILT. LASER treatments were to be performed every other day for a total of 10 sessions.
wrist splints of an appropriate size in a neutral position for at least 8 hours at night for 3 months
The Boston Symptom Severity Scale (BSSS)
The Boston Symptom Severity Scale consists of 11 questions, with each question scored between 1 and 5. The average score is calculated by summing the points received for each problem and dividing by the number of questions. A high score indicates that symptoms are severe and functional capacity is limited. The maximum score on this scale is 55 and the minimum score is 11.
Time frame: end of 1. month
The Boston Functional Capacity Scale (BFCS)
The Boston Functional Capacity Scale consists of 8 questions, with each question scored between 1 and 5. The average score is calculated by summing the points received for each problem and dividing by the number of questions. A high score indicates that symptoms are severe and functional capacity is limited. The maximum score on this scale is 40 and the minimum score is 8.
Time frame: end of 1. month
The electrophysiological examination
The electrophysiological examination was performed using the Nihon Koden Neuropack 2- MEB 7102-K device. During the electrophysiological studies, the room temperature was set at 25 C° and the temperature of the extremities was set above 32 C˚. In our study, the standard data obtained by Oh et al. were used \[17\]. In the study of motor conduction of the median nerve, a superficial rod electrode was used for recording at the abductor pollicis brevis muscle. The wrist and antecubital fossa were stimulated 6 cm proximal to the recording electrode. The combined muscle action potential (CMAP) (mV) and distal motor latency (msec) were recorded. Sensory conduction was examined by orthodromic stimulation at the 2nd finger and recording at the wrist with a superficial rod electrode. The conduction velocity of the sensory action potential (SAP) was recorded.
Time frame: end of 1. month
The ultrasound examination
The ultrasound examination was performed with a Logiq 9 (GE Medical Systems®). During the ultrasound examination, the patient was in a sitting position, arms next to the body, the elbow in 90° flexion, the forearm in supination. The cross-sectional area of the median nerve and the minor and major axes were calculated using the available programme of the ultrasound machine. The echogenic line around the nerve was not considered, and a manual drawing was made along the nerve border around the hyperechoic epineurium. From the level of the proximal carpal tunnel (distal wrist line), the scaphoid and carpal bones were determined as landmarks, and the cross-sectional area of the median nerve and the major and minor axes were measured. The flattening ratio resulting from dividing the major axis by the minor axis was recorded.
Time frame: end of 1. month
The Boston Symptom Severity Scale (BSSS)
The Boston Symptom Severity Scale consists of 11 questions, with each question scored between 1 and 5. The average score is calculated by summing the points received for each problem and dividing by the number of questions. A high score indicates that symptoms are severe and functional capacity is limited.The maximum score on this scale is 55 and the minimum score is 11.
Time frame: end of 3. month
The Boston Functional Capacity Scale (BFCS)
The Boston Functional Capacity Scale consists of 8 questions, with each question scored between 1 and 5. The average score is calculated by summing the points received for each problem and dividing by the number of questions. A high score indicates that symptoms are severe and functional capacity is limited. The maximum score on this scale is 40 and the minimum score is 8.
Time frame: end of 3. month
The electrophysiological examination
The electrophysiological examination was performed using the Nihon Koden Neuropack 2- MEB 7102-K device. During the electrophysiological studies, the room temperature was set at 25 C° and the temperature of the extremities was set above 32 C˚. In our study, the standard data obtained by Oh et al. were used \[17\]. In the study of motor conduction of the median nerve, a superficial rod electrode was used for recording at the abductor pollicis brevis muscle. The wrist and antecubital fossa were stimulated 6 cm proximal to the recording electrode. The combined muscle action potential (CMAP) (mV) and distal motor latency (msec) were recorded. Sensory conduction was examined by orthodromic stimulation at the 2nd finger and recording at the wrist with a superficial rod electrode. The conduction velocity of the sensory action potential (SAP) was recorded.
Time frame: end of 3. month
The ultrasound examination
The ultrasound examination was performed with a Logiq 9 (GE Medical Systems®). During the ultrasound examination, the patient was in a sitting position, arms next to the body, the elbow in 90° flexion, the forearm in supination. The cross-sectional area of the median nerve and the minor and major axes were calculated using the available programme of the ultrasound machine. The echogenic line around the nerve was not considered, and a manual drawing was made along the nerve border around the hyperechoic epineurium. From the level of the proximal carpal tunnel (distal wrist line), the scaphoid and carpal bones were determined as landmarks, and the cross-sectional area of the median nerve and the major and minor axes were measured. The flattening ratio resulting from dividing the major axis by the minor axis was recorded.
Time frame: end of 3. month
Plan to share: Undecided
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Ankara City Hospital Bilkent