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

NCT06219876 | Completed

• 1 other identifier: 1254
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome; Electromyography; Low-Level Laser Therapy; Ultrasound Imaging

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• The Boston Symptom Severity Scale (BSSS)

  end of 3. month

• The Boston Functional Capacity Scale (BFCS)

  end of 3. month

• The electrophysiological examination

  end of 3. month

• The ultrasound examination

  end of 3. month

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Other: wrist splint

Low Level Laser Treatment

ACTIVE COMPARATOR

* 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

High Intensity Laser Treatment

ACTIVE COMPARATOR

* 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

Interventions

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.

Low Level Laser Treatment

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.

High Intensity Laser Treatment

wrist splint OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 27751557 BACKGROUND

• 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.

  PMID: 32099632 BACKGROUND

• 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.

  PMID: 32026843 BACKGROUND

• 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.

  PMID: 33995973 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Sidar Burcu Ates Demiroglu

  Ankara Bilken City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 23, 2024
• Study Start: June 10, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

TU (1)