High Intensity Laser Therapy in Carpal Tunnel Syndrome

NCT04949373 | Completed

• 1 other identifier: Afyonkarahisar Health Sciences
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to investigate the effect of high-intensity laser therapy on pain, function, nerve conduction studies and grip strength in patients with idiopathic carpal tunnel syndrome.

Conditions

Carpal Tunnel Syndrome; Entrapment Neuropathy; Median Neuropathy; Musculoskeletal Diseases

Keywords

Carpal Tunnel Syndrome; Median Neuropathy; High intensity laser therapy; Nerve conduction studies; Hand function

Outcome Measures

Primary Outcomes (1)

• The Boston carpal tunnel questionnaire: 0(Baseline), Change from Baseline at 3rd and 12th weeks

  This questionnaire determines CTS-specific symptom severity and functional outcome using a scale for each. Symptom severity subgroup is determined using 11 questions scored from 1 to 5 and one can get 55 points at most. The higher the score, the higher the symptom severity. The function subgroup questions the difficulty of 8 functional activities scored from 1 to 5 and one can get 40 points at most. The higher the score, the worse the functional capacity.

  0(Baseline) and at 3rd and 12th weeks

Secondary Outcomes (6)

• Visual analogue scale (VAS) [ Time Frame: 0(Baseline), Change from Baseline VAS at 3rd and 12th weeks ]

  0(Baseline) and at 3rd and 12th weeks

• Median nerve distal motor latency.Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks

  0(Baseline) and at 3rd and 12th weeks

• Sensory nerve conduction velocity Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks

  0(Baseline) and at 3rd and 12th weeks

• Median nerve compound muscle action potential amplitude (CMAP): Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks

  0(Baseline) and at 3rd and 12th weeks

• Median sensory nerve action potential amplitudes: Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks

  0(Baseline) and at 3rd and 12th weeks

Study Arms (2)

HILT+nerve/tendon gliding exercise+rest splint

EXPERIMENTAL

Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily. The patients will use rest splint at night.

Device: High-intensity laser therapy (HILT)

Sham HILT+nerve/tendon gliding exercise+rest splint

SHAM COMPARATOR

Patients will receive sham laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily . The patients will use rest splint at night.

Device: Sham High-intensity laser therapy (sham HILT)

Interventions

High-intensity laser therapy (HILT) DEVICE

High intensity laser therapy-Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. A 3-phase treatment program will be performed on each session. Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist. Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks.

HILT+nerve/tendon gliding exercise+rest splint

Sham High-intensity laser therapy (sham HILT) DEVICE

Sham high intensity laser therapy-Participants will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist. Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks.

Sham HILT+nerve/tendon gliding exercise+rest splint

Eligibility Criteria

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

You may qualify if:

• Mild or moderate idiopathic carpal tunnel syndrome (clinically diagnosed and electrophysiologically confirmed CTS)

You may not qualify if:

• Diabetes mellitus,hypothyroidism, rheumatic diseases, acromegaly
• Polyneuropathy,
• Ipsilateral brachial plexopathy and traumatic nerve injury of the upper extremity
• Previous injection into the carpal tunnel and physical therapy within in the preceding 6 months
• Pregnancy
• History of malignancy
• Patients with cochlear implants

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Merkez, Afyonkarahi̇sar, 03200, Turkey (Türkiye)

Location

Related Publications (5)

• Bekhet AH, Ragab B, Abushouk AI, Elgebaly A, Ali OI. Efficacy of low-level laser therapy in carpal tunnel syndrome management: a systematic review and meta-analysis. Lasers Med Sci. 2017 Aug;32(6):1439-1448. doi: 10.1007/s10103-017-2234-6. Epub 2017 Jun 5.

  PMID: 28580494 BACKGROUND

• Dundar U, Turkmen U, Toktas H, Ulasli AM, Solak O. Effectiveness of high-intensity laser therapy and splinting in lateral epicondylitis; a prospective, randomized, controlled study. Lasers Med Sci. 2015 Apr;30(3):1097-107. doi: 10.1007/s10103-015-1716-7. Epub 2015 Jan 23.

  PMID: 25614134 BACKGROUND

• Guner A, Altan L, Kasapoglu Aksoy M. The effectiveness of the low-power laser and kinesiotaping in the treatment of carpal tunnel syndrome, a pilot study. Rheumatol Int. 2018 May;38(5):895-904. doi: 10.1007/s00296-018-4020-6. Epub 2018 Mar 28.

  PMID: 29594333 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

• Yagci I, Elmas O, Akcan E, Ustun I, Gunduz OH, Guven Z. Comparison of splinting and splinting plus low-level laser therapy in idiopathic carpal tunnel syndrome. Clin Rheumatol. 2009 Sep;28(9):1059-65. doi: 10.1007/s10067-009-1213-0. Epub 2009 Jun 21.

  PMID: 19544043 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Charcot-Marie-Tooth Disease; Median Neuropathy; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Medical Doctor

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: June 1, 2021
• Primary Completion: June 27, 2022
• Study Completion: November 15, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

TU (1)