Clinical Effectiveness of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy:

NCT04734977 | Completed

• 1 other identifier: NEHILT2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation aims to investigate the effect of high intensity laser therapy on radicular symptoms, neuropathic pain, cervical range of motion and quality of life in patients with cervical radiculopathy compared to cervical therapeutic exercises.

Conditions

Radiculopathy; Musculoskeletal Diseases; Cervical Pain; Cervical Radicular Pain; Cervical Disc Disease

Keywords

High Intensity Laser Therapy; Cervical Radicular Pain; Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline visual analog scale (VAS) neck and arm pain at 4th and 12th week

  Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

  up to 12th week

Secondary Outcomes (5)

• Change from baseline quality of life (short form 36 (SF-36)) at 4th and 12th weeks

  up to 12th week

• Change from baseline range of motion of cervical spine measurements with goniometer at 4th and 12th weeks

  up to 12th week

• Change from baseline Neck Dısabılıty Index (NDI) at 4th and 12th weeks

  up to 12th week

• Change from baseline Cervical Radiculopathy Impact Scale(CRIS) at 4th and 12th weeks

  up to 12th week

• Change from baseline Pain detect questionnaire (PD-Q) at 4th and 12th weeks

  up to 12th week

Study Arms (3)

HILT+exercise

EXPERIMENTAL

Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of four weeks, and one session per day for a total of 20 sessions. A 3-phase treatment program was performed in each session, and the patients were then given a daily exercise program once a day by a physiotherapist.

Device: High-intensity laser therapy (HILT); Other: Therapeutic Exercise

Sham HILT+exercise

SHAM COMPARATOR

Sham therapy was applied in five sessions a week for four weeks, with a total of 20 sessions a day, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist.

Device: Sham high-intensity laser therapy (Sham HILT); Other: Therapeutic Exercise

Exercise only

ACTIVE COMPARATOR

Exercise program was applied in five sessions a week for four weeks, with a total of 20 sessions a day.

Other: Therapeutic Exercise

Interventions

High-intensity laser therapy (HILT) DEVICE

High intensity laser therapy-Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of four weeks, and one session per day for a total of 20 sessions. A 3-phase treatment program was performed in each session.

HILT+exercise

Sham high-intensity laser therapy (Sham HILT) DEVICE

Sham High intensity laser therapy was applied in five sessions a week for four weeks, with a total of 20 sessions a day, with no current flowing through the device using a HIRO 3 device (ASA Laser, Arcugnano, Italy).

Sham HILT+exercise

Therapeutic Exercise OTHER

As therapeutic exercise program; active cervical ROM, cervical isometric and progressive (self-exercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises.It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions.

Exercise only; HILT+exercise; Sham HILT+exercise

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• radicular clinical symptoms
• cervical disc herniation and degenerative changes diagnosed with cervical MR
• radiculopathy findings on Electromyography (EMG) and Nerve Conduction Studies

You may not qualify if:

• Pregnancy
• Inflammatory rheumatologic diseases
• Malignity
• Structural deformity
• Previous surgery related to the cervical spine
• Cervical spinal stenosis
• Lokal corticosteroid injections
• Medications for neuropathic pain such as pregabalin or gabapentin
• Carpal tunnel syndrome, cubital tunnel syndrome
• Shoulder pathology

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

AFYON

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (3)

• Konstantinovic LM, Cutovic MR, Milovanovic AN, Jovic SJ, Dragin AS, Letic MDj, Miler VM. Low-level laser therapy for acute neck pain with radiculopathy: a double-blind placebo-controlled randomized study. Pain Med. 2010 Aug;11(8):1169-78. doi: 10.1111/j.1526-4637.2010.00907.x.

  PMID: 20704667 BACKGROUND

• Song HJ, Seo HJ, Lee Y, Kim SK. Effectiveness of high-intensity laser therapy in the treatment of musculoskeletal disorders: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Dec;97(51):e13126. doi: 10.1097/MD.0000000000013126.

  PMID: 30572425 BACKGROUND

• Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25.

  PMID: 26914684 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Musculoskeletal Diseases; Neck Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Songül İNCE, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

• Nuran EYVAZ, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: January 1, 2021
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)