Remission of Lumbar Disc Herniation by Physiotherapy

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Other: physiotherapy; Device: DRX 9000, Axiom Worldwide, Tampa, Florida; Other: spinal stabilization exercise

• Registration Number: NCT02699164
• Lead Sponsor: Hacettepe University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional physiotherapy	physiotherapy	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.
combine group	spinal stabilization exercise	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.
combine group	DRX 9000, Axiom Worldwide, Tampa, Florida	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.
conventional physiotherapy	spinal stabilization exercise	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.
combine group	physiotherapy	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.

Primary Outcome Measures

Name	Time	Method
herniation thickness	change from baseline in herniation thickness and disc height at three months	herniation thickness were measured on MRI.

Secondary Outcome Measures

Name	Time	Method
function	up to 3 months	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"
mobility	up to 3 months	straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer.
pain severity	change form baseline in pain severity at 15 sessions of treatment	numeric analog scale was used. "0" described no pain, "10" described "unbearable pain".