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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Ultrasound Imaging; Electromyography; Low-Level Laser Therapy
• Intervention / Treatment: Other: wrist splint; Device: low level laser treatment; Device: High intensity laser treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06800
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 to 65 years
2. 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:

1. 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,
2. Patients who underwent surgical treatment for CTS
3. Patients who received injections for CTS in the last 6 months
4. Patients diagnosed with severe CTS on EMG (SAP not obtained in sensory conduction studies and/or CMAP < 5 mV in motor conduction studies)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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
Active Comparator: 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 LLLT	Device: low level 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.
Active Comparator: High Intensity 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 HIRO TT (ASA, Italy) was used for HILT. LASER treatments were to be performed every other day for a total of 10 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	end of 1. month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	end of 3. month

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Sidar Burcu Ates Demiroglu, Ankara Bilken City Hospital

Publications and helpful links

General Publications

• Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.
• Ezzati K, Laakso EL, Salari A, Hasannejad A, Fekrazad R, Aris A. The Beneficial Effects of High-Intensity Laser Therapy and Co-Interventions on Musculoskeletal Pain Management: A Systematic Review. J Lasers Med Sci. 2020 Winter;11(1):81-90. doi: 10.15171/jlms.2020.14. Epub 2020 Jan 18.
• Cheung WKW, Wu IXY, Sit RWS, Ho RST, Wong CHL, Wong SYS, Chung VCH. Low-level laser therapy for carpal tunnel syndrome: systematic review and network meta-analysis. Physiotherapy. 2020 Mar;106:24-35. doi: 10.1016/j.physio.2019.06.005. Epub 2019 Jun 20.
• Hojjati F, Afjei MH, Ebrahimi Takamjani I, Rayegani SM, Sarrafzadeh J, Raeissadat SA, Payami S. The Effect of High-Power and Low-Power Lasers on Symptoms and the Nerve Conduction Study in Patients With Carpal Tunnel Syndrome. A Prospective Randomized Single-Blind Clinical Trial. J Lasers Med Sci. 2020 Fall;11(Suppl 1):S73-S79. doi: 10.34172/jlms.2020.S12. Epub 2020 Dec 30.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 21, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 1254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No