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Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non -surgical spinal decompression therapy
deep friction massage,
electrotherapy
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 exercise, deep friction massage, spinal decompression, non-surgical spinal decompression

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    spinal decompression group

    combine group

    exercise group

    Arm Description

    only 15 sessions of spinal decompression therapy were applied.

    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.

    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

    Outcomes

    Primary Outcome Measures

    magnetic resonance imaging changes
    changes recorded in micrometrical measurements.

    Secondary Outcome Measures

    disability
    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"
    performance
    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.
    pain
    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.
    straight leg raise test for mobility
    Therapist raised patient's leg passively and the pain felt by the patient measured with goniometer and the angle recorded.
    neuropathic pain
    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.
    fear avoidance beliefs
    FABQ used to assess fear related attitudes of the patients. Scores range from 0 to 42 . Higher points described high fear avoidance beliefs.

    Full Information

    First Posted
    July 15, 2015
    Last Updated
    February 23, 2016
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02572622
    Brief Title
    Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment
    Official Title
    Lumbal Disk Herniasyonunda Farklı Tedavi Yöntemlerinin Karşılaştırılması
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 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
    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.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    spinal decompression group
    Arm Type
    Experimental
    Arm Description
    only 15 sessions of spinal decompression therapy were applied.
    Arm Title
    combine group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    exercise group
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    non -surgical spinal decompression therapy
    Intervention Description
    it is a kind of traction therapy, it has an special traction design which can provide intermittent traction as to herniation levels.
    Intervention Type
    Other
    Intervention Name(s)
    deep friction massage,
    Intervention Description
    deep friction massage is a kind of massage targeting deep muscles for decreasing pain and increasing function
    Intervention Type
    Other
    Intervention Name(s)
    electrotherapy
    Intervention Description
    electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.
    Intervention Type
    Other
    Intervention Name(s)
    exercise
    Intervention Description
    special lumbar stabilization exercises were applied in advanced protocol.
    Primary Outcome Measure Information:
    Title
    magnetic resonance imaging changes
    Description
    changes recorded in micrometrical measurements.
    Time Frame
    change from baseline in disc height and size of herniation at 3 months.
    Secondary Outcome Measure Information:
    Title
    disability
    Description
    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
    performance
    Description
    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.
    Time Frame
    up to 3 months.
    Title
    pain
    Description
    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.
    Time Frame
    up to 3 months.
    Title
    straight leg raise test for mobility
    Description
    Therapist raised patient's leg passively and the pain felt by the patient measured with goniometer and the angle recorded.
    Time Frame
    up to 3 months
    Title
    neuropathic pain
    Description
    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.
    Time Frame
    up to 3 months.
    Title
    fear avoidance beliefs
    Description
    FABQ used to assess fear related attitudes of the patients. Scores range from 0 to 42 . Higher points described high fear avoidance beliefs.
    Time Frame
    up to 3 months.

    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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    aynur demirel, PhD
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    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
    background
    PubMed Identifier
    17511872
    Citation
    Daniel DM. Non-surgical spinal decompression therapy: does the scientific literature support efficacy claims made in the advertising media? Chiropr Osteopat. 2007 May 18;15:7. doi: 10.1186/1746-1340-15-7.
    Results Reference
    background
    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
    16249899
    Citation
    Ozturk B, Gunduz OH, Ozoran K, Bostanoglu S. Effect of continuous lumbar traction on the size of herniated disc material in lumbar disc herniation. Rheumatol Int. 2006 May;26(7):622-6. doi: 10.1007/s00296-005-0035-x. Epub 2005 Oct 25.
    Results Reference
    background
    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
    background
    PubMed Identifier
    14715404
    Citation
    Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. doi: 10.1016/j.pain.2003.10.017. Erratum In: Pain. 2004 May;109(1-2):200-1.
    Results Reference
    background
    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
    background
    PubMed Identifier
    11041196
    Citation
    Meszaros TF, Olson R, Kulig K, Creighton D, Czarnecki E. Effect of 10%, 30%, and 60% body weight traction on the straight leg raise test of symptomatic patients with low back pain. J Orthop Sports Phys Ther. 2000 Oct;30(10):595-601. doi: 10.2519/jospt.2000.30.10.595.
    Results Reference
    background

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    Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

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