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Completed

NCT Number: NCT06219876

Comparison of the Efficacy of High Intensity Laser Therapy and Low Level Laser Therapy in the Carpal Tunnel Syndrome

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 to 65 years
  • Mild CTS (sensory conduction velocity at the second finger wrist < 41.26 m/sec, motor distal latency < 3.60 msec) or Moderate CTS (sensory conduction velocity at the second finger wrist < 41.26 m/sec and motor distal latency > 3.60 msec) according to the electrophysiological data were included in the study.

Exclusion criteria

  • Patients with local (osteophytes, ganglion cysts, lipomas, muscle and tendon abnormalities, etc.) and systemic (diabetes mellitus, acromegaly, hypothyroidism, pregnancy, etc.) diseases causing symptoms were included in the study.) causing CTS,
  • Patients who underwent surgical treatment for CTS
  • Patients who received injections for CTS in the last 6 months
  • Patients diagnosed with severe CTS on EMG (SAP not obtained in sensory conduction studies and/or CMAP < 5 mV in motor conduction studies)

Treatment and study plan

low level laser treatment

Device

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.

High intensity laser treatment

Device

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 splint

Other

wrist splints of an appropriate size in a neutral position for at least 8 hours at night for 3 months

Primary outcomes

  1. The Boston Symptom Severity Scale (BSSS)

    Time frame: end of 1. month

    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.

  2. The Boston Functional Capacity Scale (BFCS)

    Time frame: end of 1. month

    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.

  3. The electrophysiological examination

    Time frame: end of 1. month

    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.

  4. The ultrasound examination

    Time frame: end of 1. month

    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.

Secondary outcomes

  1. The Boston Symptom Severity Scale (BSSS)

    Time frame: end of 3. month

    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.

  2. The Boston Functional Capacity Scale (BFCS)

    Time frame: end of 3. month

    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.

  3. The electrophysiological examination

    Time frame: end of 3. month

    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.

  4. The ultrasound examination

    Time frame: end of 3. month

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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