Effectiveness of High Intensity Laser Therapy in Management of Lumbar Disc Herniation

NCT07550569 | Not Yet Recruiting

• 1 other identifier: KA25/356
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

Chronic lumbar radiculopathy is a multifactorial condition typically caused by lumbar disc herniation, where degenerative changes lead to nerve root compression, resulting in radiating pain, sensory disturbances, and motor deficits. Management requires a multidisciplinary, primarily conservative approach centered on physical therapy, including exercise, electrotherapy, and other non-invasive modalities. Exercise plays a key role in improving spinal stability, mobility, posture, and neuromuscular coordination, while treatments like transcutaneous electrical nerve stimulation (TENS) and high-intensity laser therapy (HILT) provide pain relief through neuromodulation and tissue regeneration mechanisms. Recent evidence suggests that combining HILT with exercise may enhance functional outcomes more effectively than exercise alone. Accordingly, this study aims to compare the effectiveness of exercise alone, exercise combined with HILT, and exercise combined with conventional therapies (ultrasound, hot pack, and TENS) in patients with lumbar disc herniation. Patients aged 18-65 will be randomly assigned to three groups and undergo a 3-week treatment program, with outcomes assessed through measures of pain, disability, range of motion, and quality of life.

Conditions

Lomber Disc Herniation

Keywords

Intervertebral Disc Displacement; Back Pain; Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The Visual Analog Scale (VAS) is a simple and widely used tool for assessing pain intensity by allowing patients to indicate their perceived level of pain on a continuous scale. It typically consists of a 10 cm line anchored by two extremes, "no pain" and "worst imaginable pain," on which the patient marks their current pain level. The score is determined by measuring the distance from the "no pain" end to the marked point, providing a value between 0 and 10, with higher scores indicating greater pain severity. VAS is favored in both clinical practice and research due to its ease of use, sensitivity to changes over time, and ability to quantitatively track treatment outcomes, although it may be less reliable in individuals with cognitive or communication difficulties.

  3 months

Secondary Outcomes (2)

• • Functional disability via Oswestry Disability Index

  3 months

• Short form-36

  3 months

Other Outcomes (1)

• Lumbar Range of Motion via goniometer (flexion, extension, lateral flexion, rotation, 3 trials, mean)

  3 months

Study Arms (3)

hiltherapy

EXPERIMENTAL

In this group Nd:YAG laser (1064 nm) will be applied to participants with high-peak power (3 kW), pulse duration 120-150 μs, frequency 10-30 Hz, energy density 360-1780 mJ/cm². Protective eyewear will be used. Protocol: scanning phase (rapid paravertebral scan), initial phase (trigger point scan), and final phase (slow scan of initial area). Total energy: 2,500 J/cm² (1,000 + 500 + 1,000). 15 sessions will be applied for 3 weeks, 15 min/session. Participants will also receive 15 sessions (5 sessions/week for 3 weeks).

Device: Hiltherapy

Physiotherapy

ACTIVE COMPARATOR

US + Hot pack + TENS will be applied to the participants. Hot pack (15 × 50 cm, 15 min), ultrasound (1 MHz, 1.5 W/cm², 4+4 min bilateral), and TENS (20 min, 80 Hz, 180 μs, 4 electrodes 5 × 5 cm) will be applied for 15 sessions for 3 weeks. Participants will also receive 15 sessions (5 sessions/week for 3 weeks).

Device: physiotherapy

control group

NO INTERVENTION

Participants will receive 15 sessions (5 sessions/week for 3 weeks). Each session will last 15 minutes under physiotherapist supervision and include lumbar extension, pelvic tilt, and core stabilization exercises as tolerated.

Interventions

Hiltherapy DEVICE

Nd:YAG laser (1064 nm) will be applied to the participants with high-peak power (3 kW), pulse duration 120-150 μs, frequency 10-30 Hz, energy density 360-1780 mJ/cm². Protective eyewear will be used. Protocol: scanning phase (rapid paravertebral scan), initial phase (trigger point scan), and final phase (slow scan of initial area). Total energy: 2,500 J/cm² (1,000 + 500 + 1,000). 15 sessions for 3 weeks, 15 min/session.

hiltherapy

physiotherapy DEVICE

Combination of US + Hot pack + TENS will be applied to the participants Hot pack (15 × 50 cm, 15 min), ultrasound (1 MHz, 1.5 W/cm², 4+4 min bilateral), and TENS (20 min, 80 Hz, 180 μs, 4 electrodes 5 × 5 cm) for 15 sessions for 3 weeks.

Physiotherapy

Eligibility Criteria

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

You may qualify if:

• Males and females aged 18-65 years
• Diagnosed with lumbar disc herniation via MRI and presenting with low back pain
• No History of lumbar physical therapy in the last 3 months
• No History of analgesic or muscle relaxant use since initial presentation
• Willingness to participate and signed informed consent

You may not qualify if:

• History of Fibromyalgia diagnosis
• History of acute trauma
• History of Lumbar instability
• History of Rheumatologic disease
• Motor deficits or myelopathy
• History of Lumbar injections in the last 3 months
• History of Previous lumbar surgery
• Pregnancy
• Pacemaker
• Cognitive impairment or unwillingness to comply with treatment

Sponsors & Collaborators

• Baskent University: lead

Study Sites (3)

Baskent University

Ankara, Bahcelievler, 06490, Turkey (Türkiye)

Location

Baskent University

Ankara, 06490, Turkey (Türkiye)

Location

Başkent University Ankara Hospital

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Sevgi İkbali Afşar, Prof. Dr.

  BASKENT UNİVERSİTY

  STUDY DIRECTOR

Central Study Contacts

Ozlem Kuculmez, assist prof dr

CONTACT

+905556205210; ahmedzmm@outlook.com

Derya aydil

CONTACT

+903122129065/2234; etikkurul@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)