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Remission of Lumbar Disc Herniation by Physiotherapy

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ClinicalTrials.gov Identifier: NCT02699164
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Aynur Demirel, 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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Device: DRX 9000, Axiom Worldwide, Tampa, Florida Other: physiotherapy Other: spinal stabilization exercise Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lumbal Disk Herniasyonunda farklı Tedavi yöntemlerinin etkinliğinin karşılaştırılması
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: combine group

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
non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).

Other: physiotherapy
electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.

Other: spinal stabilization exercise
spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.

Experimental: conventional 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.
Other: physiotherapy
electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.

Other: spinal stabilization exercise
spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.




Primary Outcome Measures :
  1. herniation thickness [ Time Frame: change from baseline in herniation thickness and disc height at three months ]
    herniation thickness were measured on MRI.


Secondary Outcome Measures :
  1. function [ Time Frame: 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"


  2. mobility [ Time Frame: up to 3 months ]
    straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer.

  3. pain severity [ Time Frame: change form baseline in pain severity at 15 sessions of treatment ]
    numeric analog scale was used. "0" described no pain, "10" described "unbearable pain".



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699164


Sponsors and Collaborators
Hacettepe University
Investigators
Principal Investigator: Aynur Demirel, PhD Hacettepe University
Principal Investigator: Nevin Ergun, Proff Hacettepe University
Principal Investigator: Mehmet Yorubulut, MD Acıbadem Hospital

Publications of Results:

Other Publications:
Responsible Party: Aynur Demirel, Research asisstant, Hacettepe University
ClinicalTrials.gov Identifier: NCT02699164     History of Changes
Other Study ID Numbers: GO14-265
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aynur Demirel, Hacettepe University:
non surgical spinal decompression therapy
deep friction massage
exercise

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical