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Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

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ClinicalTrials.gov Identifier: NCT02572622
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Aynur Demirel, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Other: non -surgical spinal decompression therapy Other: deep friction massage, Other: electrotherapy Other: exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lumbal Disk Herniasyonunda Farklı Tedavi Yöntemlerinin Karşılaştırılması
Study Start Date : February 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: 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.




Primary Outcome Measures :
  1. magnetic resonance imaging changes [ Time Frame: change from baseline in disc height and size of herniation at 3 months. ]
    changes recorded in micrometrical measurements.


Secondary Outcome Measures :
  1. 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"

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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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:

  • 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

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): NCT02572622


Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: aynur demirel, PhD Hacettepe University

Publications:

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Responsible Party: Aynur Demirel, research assistant Aynur Demirel, Hacettepe University
ClinicalTrials.gov Identifier: NCT02572622     History of Changes
Other Study ID Numbers: HacettepeUN
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

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

Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical