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Remission of Lumbar Disc Herniation by Physiotherapy

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DRX 9000, Axiom Worldwide, Tampa, Florida
physiotherapy
spinal stabilization exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring non surgical spinal decompression therapy, deep friction massage, exercise

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    combine group

    conventional physiotherapy

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    herniation thickness
    herniation thickness were measured on MRI.

    Secondary Outcome Measures

    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"
    mobility
    straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer.
    pain severity
    numeric analog scale was used. "0" described no pain, "10" described "unbearable pain".

    Full Information

    First Posted
    February 25, 2016
    Last Updated
    August 15, 2016
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02699164
    Brief Title
    Remission of Lumbar Disc Herniation by Physiotherapy
    Official Title
    Lumbal Disk Herniasyonunda farklı Tedavi yöntemlerinin etkinliğinin karşılaştırılması
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation
    Keywords
    non surgical spinal decompression therapy, deep friction massage, exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    combine group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    conventional physiotherapy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    DRX 9000, Axiom Worldwide, Tampa, Florida
    Intervention Description
    non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).
    Intervention Type
    Other
    Intervention Name(s)
    physiotherapy
    Intervention Description
    electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.
    Intervention Type
    Other
    Intervention Name(s)
    spinal stabilization exercise
    Intervention Description
    spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.
    Primary Outcome Measure Information:
    Title
    herniation thickness
    Description
    herniation thickness were measured on MRI.
    Time Frame
    change from baseline in herniation thickness and disc height at three months
    Secondary Outcome Measure Information:
    Title
    function
    Description
    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"
    Time Frame
    up to 3 months
    Title
    mobility
    Description
    straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer.
    Time Frame
    up to 3 months
    Title
    pain severity
    Description
    numeric analog scale was used. "0" described no pain, "10" described "unbearable pain".
    Time Frame
    change form baseline in pain severity at 15 sessions of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aynur Demirel, PhD
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nevin Ergun, Proff
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mehmet Yorubulut, MD
    Organizational Affiliation
    Acıbadem Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11411624
    Citation
    Lundon K, Bolton K. Structure and function of the lumbar intervertebral disk in health, aging, and pathologic conditions. J Orthop Sports Phys Ther. 2001 Jun;31(6):291-303; discussion 304-6. doi: 10.2519/jospt.2001.31.6.291.
    Results Reference
    background
    PubMed Identifier
    20615252
    Citation
    Apfel CC, Cakmakkaya OS, Martin W, Richmond C, Macario A, George E, Schaefer M, Pergolizzi JV. Restoration of disk height through non-surgical spinal decompression is associated with decreased discogenic low back pain: a retrospective cohort study. BMC Musculoskelet Disord. 2010 Jul 8;11:155. doi: 10.1186/1471-2474-11-155.
    Results Reference
    result
    PubMed Identifier
    20689695
    Citation
    Schoenfeld AJ, Weiner BK. Treatment of lumbar disc herniation: Evidence-based practice. Int J Gen Med. 2010 Jul 21;3:209-14. doi: 10.2147/ijgm.s12270.
    Results Reference
    result
    PubMed Identifier
    18427321
    Citation
    Lurie JD, Tosteson AN, Tosteson TD, Carragee E, Carrino JA, Kaiser J, Sequeiros RT, Lecomte AR, Grove MR, Blood EA, Pearson LH, Herzog R, Weinstein JN. Reliability of magnetic resonance imaging readings for lumbar disc herniation in the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Apr 20;33(9):991-8. doi: 10.1097/BRS.0b013e31816c8379. Erratum In: Spine. 2008 Oct 15;33(22):2482.. Carrino, John [corrected to Carrino, John A].
    Results Reference
    result
    PubMed Identifier
    17119140
    Citation
    Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.
    Results Reference
    result
    PubMed Identifier
    22744541
    Citation
    Romanowski M, Romanowska J, Grzeskowiak M. A comparison of the effects of deep tissue massage and therapeutic massage on chronic low back pain. Stud Health Technol Inform. 2012;176:411-4.
    Results Reference
    result
    PubMed Identifier
    21091049
    Citation
    Hahne AJ, Ford JJ, Hinman RS, Taylor NF, Surkitt LD, Walters AG, McMeeken JM. Outcomes and adverse events from physiotherapy functional restoration for lumbar disc herniation with associated radiculopathy. Disabil Rehabil. 2011;33(17-18):1537-47. doi: 10.3109/09638288.2010.533814. Epub 2010 Nov 20.
    Results Reference
    result
    PubMed Identifier
    25729196
    Citation
    Choi J, Lee S, Hwangbo G. Influences of spinal decompression therapy and general traction therapy on the pain, disability, and straight leg raising of patients with intervertebral disc herniation. J Phys Ther Sci. 2015 Feb;27(2):481-3. doi: 10.1589/jpts.27.481. Epub 2015 Feb 17.
    Results Reference
    result

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    Remission of Lumbar Disc Herniation by Physiotherapy

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