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Completed

NCT Number: NCT02572622

Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non -surgical spinal decompression therapy

Other

it is a kind of traction therapy, it has an special traction design which can provide intermittent traction as to herniation levels.

deep friction massage,

Other

deep friction massage is a kind of massage targeting deep muscles for decreasing pain and increasing function

electrotherapy

Other

electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.

Exercise

Other

special lumbar stabilization exercises were applied in advanced protocol.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Lumbal Disk Herniasyonunda Farklı Tedavi Yöntemlerinin Karşılaştırılması

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2015
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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