Actively Recruiting
Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation
Led by Ankara City Hospital Bilkent · Updated on 2024-10-26
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of High Intensity Laser Therapy (HILT) on disability, functionality, and pain in adults with chronic radicular low back pain caused by lumbar disc herniation. This study compares HILT to conventional electrotherapy methods to determine if HILT offers better short- and long-term relief of low back and leg pain. The trial includes both male and female patients aged 18 to 65 years with radicular pain confirmed by lumbar MRI and lasting more than 12 weeks. Participants are randomly assigned to one of two groups: Group A receives 15 sessions of Hotpack, Transcutaneous Electrical Nerve Stimulation (TENS), HILT using a specific device mode, and home exercise programs focusing on lumbar strengthening and core stabilization. Group B receives the same Hotpack, TENS, and exercises but with sham HILT treatment instead of active laser therapy. Treatments occur five days a week for three weeks, totaling 15 sessions. Patients will be assessed before treatment, immediately after completing treatment, and again at three months follow-up. Evaluations include questionnaires on disability, life functions, and pain using tools such as the Visual Analogue Scale (VAS), Revised Oswestry Disability Index (ODI), Nottingham Health Profile (NHP), and LANSS Pain Scale. The study monitors short- and long-term effects of the therapies on pain and function.
CONDITIONS
Brief Title
Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with lumbar radiculopathy due to lumbar disc herniation confirmed by lumbar MRI
- Patients aged 18 to 65 years
- Patients who agree to participate in the study
- Literate patients
You will not qualify if you...
- Pregnancy
- Presence of cardiac pacemakers
- Diagnosis of inflammatory rheumatic disease
- Diagnosis of polyneuropathy that prevents treatment
- Active or history of malignancy within the last year with ongoing chemotherapy or radiotherapy
- Serious psychiatric illness
- Severe coagulation disorders
- Spinal stenosis with spinal canal diameter less than 8 mm
- Neurologic deficits preventing treatment
- Active infection
- Vasculitis
- Skin disease at the treatment area
- Steroid injections or physical therapy for the lumbar region within the last 3 months
- Previous lumbar spine surgery
- Acute trauma
- History of lumbar instability
- Uncontrolled or severe cardiovascular or metabolic disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive 15 sessions over 3 weeks of hotpack, TENS, and exercises plus either high intensity laser therapy or sham laser therapy.
5 visits per week for 3 weeks
Duration - 3 months
Participants are evaluated immediately after treatment and again at 3 months to assess pain and disability outcomes.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Ankara Bilkent City Hospital
Ankara, Cankaya, Turkey (Türkiye), 06100
Actively Recruiting
Research Team
B
Berke Aras, associated professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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