Remission of Lumbar Disc Herniation by Physiotherapy

Study Overview
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Brief Summary
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This study was conducted with the aim of determining whether or not Non surgical spinal decompression therapy was effective in remission of herniation, decreasing pain and improving functional status.

Detailed Description
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Both groups received combination of electrotherapy, deep friction massage and stabilization exercise for fifteen session. Combine group received non surgical spinal decompression therapy (NSDT) different from conventional physiotherapy group. Numeric Analog Scale, Straight leg raise (SLR) test, Oswestry Disability Index (ODI) were applied at baseline and after treatment. Disc height and herniation thickness were measured on Magnetic Resonance Imagination (MRI) which performed at baseline and three months after therapy.

Official Title
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Lumbal Disk Herniasyonunda farklı Tedavi yöntemlerinin etkinliğinin karşılaştırılması

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Device: DRX 9000, Axiom Worldwide, Tampa, Florida
* Other: physiotherapy
* Other: spinal stabilization exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed as lumbar disc herniation suffering from low back pain at least 8 weeks Exclusion Criteria: undergone any spinal surgery clinical diagnosis of osteoporosis clinical diagnosis of scoliosis and spondylolisthesis any neurological disease causes sensorial loss

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combine group<br>Conventional physiotherapy applied 15 sessions of treatment. In addition to conventional physiotherapy non-surgical spinal decompression therapy applied. First 10 sessions of treatment non-surgical decompression therapy applied and last 5 sessions spinal stabilization exercise applied. | Device: DRX 9000, Axiom Worldwide, Tampa, Florida<br>* non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).<br>Other: physiotherapy<br>* electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.<br>Other: spinal stabilization exercise<br>* spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.<br>|
| Experimental: conventional physiotherapy<br>conventional physiotherapy applied 15 sessions of treatment. Conventional physiotherapy consisted hotpack, Transcutaneal Electric Nerve Stimulation(TENS) and Ultrasound Currents. Spinal stabilization exercises applied last five sessions of therapy. | Other: physiotherapy<br>* electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.<br>Other: spinal stabilization exercise<br>* spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| herniation thickness | herniation thickness were measured on MRI. | change from baseline in herniation thickness and disc height at three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| function | Oswestry Disability Index was used.Oswestry Disability Index used to assess the changes in function and disability levels. Scores range from 0 to 100. scores between 0 and 20 described as minimal disability, scores between 21and 40 described as moderate disability,scores between 41and 60 described as severe disability,scores between 61 and 80 described as crippled and scores between 81 and 100 described as  bed bounded | up to 3 months | 
| mobility | straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer. | up to 3 months | 
| pain severity | numeric analog scale was used. 0 described no pain, 10 described unbearable pain. | change form baseline in pain severity at 15 sessions of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non surgical spinal decompression therapy, deep friction massage, exercise