Clinical trial NCT06219876: Comparison of the Efficacy of High Intensity Laser Therapy and Low Level Laser Therapy in the Carpal Tunnel Syndrome
Official title: Comparison of the Efficacy of High Intensity Laser Therapy and Low Level Laser Therapy in the Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Electromyography
Low-Level Laser Therapy
Ultrasound Imaging
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The Boston Symptom Severity Scale (BSSS)
timeFrame: end of 1. month
measure: The Boston Functional Capacity Scale (BFCS)
timeFrame: end of 1. month
measure: The electrophysiological examination
timeFrame: end of 1. month
measure: The ultrasound examination
timeFrame: end of 1. month
Secondary outcomes:
measure: The Boston Symptom Severity Scale (BSSS)
timeFrame: end of 3. month
measure: The Boston Functional Capacity Scale (BFCS)
timeFrame: end of 3. month
measure: The electrophysiological examination
timeFrame: end of 3. month
measure: The ultrasound examination
timeFrame: end of 3. month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Cankaya
Study officials:
affiliation: Ankara Bilken City Hospital
name: Sidar Burcu Ates Demiroglu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.