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

NCT ID: NCT06219876

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-03-01

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome Electromyography Low-Level Laser Therapy Ultrasound Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

wrist splint

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

low level laser treatment

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

High intensity laser treatment

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

wrist splint

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Handan Elif Nur BAYRAKTAR

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sidar Burcu Ates Demiroglu

Role: PRINCIPAL_INVESTIGATOR

Ankara Bilken City Hospital

Locations

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Ankara City Hospital

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27751557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32099632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32026843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33995973 (View on PubMed)

Other Identifiers

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1254

Identifier Type: -

Identifier Source: org_study_id

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