High Intensity Laser Therapy in Carpal Tunnel Syndrome

Sponsor

Afyonkarahisar Health Sciences University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04949373

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome Entrapment Neuropathy Median Neuropathy Musculoskeletal Diseases	Device: High-intensity laser therapy (HILT) Device: Sham High-intensity laser therapy (sham HILT)	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Efficacy of High Intensity Laser (HILT) Therapy in Idiopathic Carpal Tunnel Syndrome

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jun 27, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HILT+nerve/tendon gliding exercise+rest splint 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) 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.
Sham Comparator: Sham HILT+nerve/tendon gliding exercise+rest splint 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) 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.

Arm

Intervention/Treatment

Experimental: HILT+nerve/tendon gliding exercise+rest splint

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)

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.

Sham Comparator: Sham HILT+nerve/tendon gliding exercise+rest splint

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)

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
Pain intensity will be measured with visual analogue scale (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
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]
The compound muscle action potential amplitude(CMAP) will be obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode will be placed on the muscle belly and the reference electrode will be placed on the tendon insertion. The median nerve will be stimulated 8 cm proximal to the active recording electrode. Distal motor latencies will be measured from the onset of stimulus artifact to the onset of the CMAP.
Sensory nerve conduction velocity Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks [0(Baseline) and at 3rd and 12th weeks]
Sensory nerve action potential amplitudes (SNAP) will be obtained using an orthodromic method and recorded by surface electrodes placed at the wrist The median nerves will be stimulated at the proximal and distal interphalangeal joints of the index finger . Distal sensory latencies will be measured from the onset of the stimulus artifact to the onset of the SNAP. Sensory nerve conduction velocity will be calculated dividing the distance by the distal sensory latency.
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]
The CMAPs will be obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode will be placed on the muscle belly, and the reference electrode will be placed on the tendon insertion. The median nerve will be stimulated 8 cm proximal to the active recording electrode. The amplitude of CMAP will be measured from baseline to negative peak.
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]
Sensory nerve action potential amplitudes (SNAP) will be obtained using an orthodromic method and recorded by surface electrodes placed at the wrist The median nerves will be stimulated at the proximal and distal interphalangeal joints of the index finger and palm . Distal sensory latencies will be measured from the onset of the stimulus artifact to the onset of the SNAP.
Grip strength: Time Frame:0(Baseline), Change from Baseline at 3rd and 12th weeks [0(Baseline) and at 3rd and 12th weeks]
In the evaluation of grip strength, a hand dynamometer (JAMAR) will be used for grip strength and a pinchmeter will be used for the evaluation of the pulp to pulp grip. The patient will perform three consecutive tests while sitting with their shoulder abducted and neutrally rotated, elbow flexed at 90°, and forearm and wrist in neutral position.The best of these measurements will be recorded in kilograms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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