Clinical trial NCT04949373: High Intensity Laser Therapy in Carpal Tunnel Syndrome
Official title: Evaluation of the Efficacy of High Intensity Laser (HILT) Therapy in Idiopathic Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 60
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: 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.

Detailed description: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and it causes numbness and tingling in the hand, atrophy and muscle weakness in the later stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel may increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. In majority of cases, no cause can be found and it is called "idiopathic".

While the diagnosis of CTS is made by the patient's history and physical examination methods, the diagnosis is confirmed with use of electrophysiological examination. Physical therapy, non-steroidal anti-inflammatory drug use, local steroid injection, hand-wrist rest splint, nerve/tendon gliding exercises; Physiotherapy modalities such as therapeutic ultrasound and laser are among the conservative treatment methods of CTS. Despite the effectiveness of surgery in the treatment of severe CTS cases, as is known, surgical treatment is not without risk. Therefore, mild to moderate CTS is treated conservatively.

Laser therapy is one of the physical therapy modalities, low-intensity laser therapy (LILT), whose biological effects occur secondary to direct photochemical effect and are not the result of thermal effects. High-intensity laser therapy (HILT), which has been widely used recently, is frequently used since it has small and slow light absorption from chromophores. HILT is not a concentrated light, but it diffuses in all directions (scattering phenomenon). This supports the wider effectiveness of HILT. HILT also has effects such as increased mitochondrial oxidative reactions, increased production of adenosine triphosphate, RNA and DNA (photochemical effect), increased tissue stimulation (photobiological), and reduced pain and inflammation. HILT, which has recently found many uses in musculoskeletal diseases, can affect a wider and deeper area in the tissues compared to the widely used LILT. Although there are many studies on the effectiveness of LILT therapy in CTS, there are few trials to study the effectiveness of HILT on clinical and electrophysiological parameters in CTS.

This investigation is designed as double-blind prospective sham controlled randomized study.

Participants were randomized into 2 groups: 1) HILT + nerve/tendon gliding exercises + rest splint and 2) Sham HILT+ nerve/tendon gliding exercises + rest splint

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Boston carpal tunnel questionnaire: 0(Baseline), Change from Baseline at 3rd and 12th weeks
timeFrame: 0(Baseline) and at 3rd and 12th weeks
Secondary outcomes:
measure: Visual analogue scale (VAS) [ Time Frame: 0(Baseline), Change from Baseline VAS at 3rd and 12th weeks ]
timeFrame: 0(Baseline) and at 3rd and 12th weeks
measure: Median nerve distal motor latency.Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
timeFrame: 0(Baseline) and at 3rd and 12th weeks
measure: Sensory nerve conduction velocity Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
timeFrame: 0(Baseline) and at 3rd and 12th weeks
measure: Median nerve compound muscle action potential amplitude (CMAP): Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
timeFrame: 0(Baseline) and at 3rd and 12th weeks
measure: Median sensory nerve action potential amplitudes: Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
timeFrame: 0(Baseline) and at 3rd and 12th weeks
measure: Grip strength: Time Frame:0(Baseline), Change from Baseline at 3rd and 12th weeks
timeFrame: 0(Baseline) and at 3rd and 12th weeks
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Afyonkarahisar Health Sciences University
state: Afyonkarahi̇sar
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
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: 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.