Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

February 23, 2016 updated by: Aynur Demirel, Hacettepe University

Lumbal Disk Herniasyonunda Farklı Tedavi Yöntemlerinin Karşılaştırılması

The aim of this study is to determine the effectiveness of three different treatment methods which consists spinal decompression, deep friction massage and exercise. The patients were separated three groups Group one received non-surgical spinal decompression therapy, group two received non-surgical spinal decompression, lumbar stabilization exercises and manual therapy, group three received manual therapy and lumbar stabilization exercises. All groups completed 15 sessions of therapy. In each session, pain severity was assessed with numeric analog scale, straight leg raise test applied and the degree of the hip flexion where the patient reported pain were recorded, respectively. Static, dynamic muscle strength-endurance tests were applied before the treatment sessions started, after the treatment sessions ended, six weeks after and three months after the study. Oswestry Disability Scale (ODI), Back Performance Scale (BPS), Lanss Neuropathic pain Questionnaire, Fear-Avoidance-Beliefs Questionnaire (FABQ) and McGill Pain Questionnaire were applied before the treatment sessions started, after the treatment sessions ended and three months after the study. Gradient of disc height and thickness of the herniation were assessed segmentally with magnetic resonance imagination (MRI) before the study and three months after the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of lumbar disc herniation without strengthening loss

Exclusion Criteria:

  • clinical diagnosis of osteoporosis
  • have scoliosis and spondylolisthesis
  • any surgery related spine
  • any neurological diseases causes sensory loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: spinal decompression group
only 15 sessions of spinal decompression therapy were applied.
Other: non -surgical spinal decompression therapy
it is a kind of traction therapy, it has an special traction design which can provide intermittent traction as to herniation levels.
Experimental: combine group
10 patients participated in this group. for two weeks electrotherapy, deep friction massage and traction and last two weeks electrotherapy and exercise totally 15 session of treatment were applied.
Other: non -surgical spinal decompression therapy
it is a kind of traction therapy, it has an special traction design which can provide intermittent traction as to herniation levels.
Other: deep friction massage,
deep friction massage is a kind of massage targeting deep muscles for decreasing pain and increasing function
Other: electrotherapy
electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.
Other: exercise
special lumbar stabilization exercises were applied in advanced protocol.
Experimental: exercise group
10 patients participated in this group. for two weeks electrotherapy, deep friction massage and last two weeks electrotherapy and exercise totally 15 session of treatment were applied whi
Other: deep friction massage,
deep friction massage is a kind of massage targeting deep muscles for decreasing pain and increasing function
Other: electrotherapy
electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.
Other: exercise
special lumbar stabilization exercises were applied in advanced protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
magnetic resonance imaging changes
Time Frame: change from baseline in disc height and size of herniation at 3 months.
changes recorded in micrometrical measurements.
change from baseline in disc height and size of herniation at 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disability
Time Frame: up to 3 months.
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.
performance
Time Frame: up to 3 months.
back performance scale used to assess the changes in performance. Scores range from 0 to 15. The lower scores described good performance and higher scores described bad performance.
up to 3 months.
pain
Time Frame: up to 3 months.
McGill Pain Questionnaire used to asses the changes in pain levels. scores range from 0 to 78. The higher the pain score the greater the pain.
up to 3 months.
straight leg raise test for mobility
Time Frame: up to 3 months
Therapist raised patient's leg passively and the pain felt by the patient measured with goniometer and the angle recorded.
up to 3 months
neuropathic pain
Time Frame: up to 3 months.
The Leeds Assessment of Neuropathic Symptom and Signs (LANSS) Pain Scale used to assess neuropathic pain. Scores range from 0 to 24. scores higher from 12 described neuropathic pain.
up to 3 months.
fear avoidance beliefs
Time Frame: up to 3 months.
FABQ used to assess fear related attitudes of the patients. Scores range from 0 to 42 . Higher points described high fear avoidance beliefs.
up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Aynur Demirel, PhD, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HacettepeUN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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