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Lumbar Disc HerniationNCT02572622

Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

A study testing non -surgical spinal decompression therapy, deep friction massage, and electrotherapy in people with Lumbar Disc Herniation, run by Hacettepe University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
non -surgical spinal decompression therapy, deep friction massage, and electrotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Feb 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • clinical diagnosis of lumbar disc herniation without strengthening loss

Who cannot join

  • clinical diagnosis of osteoporosis
  • have scoliosis and spondylolisthesis
  • any surgery related spine
  • any neurological diseases causes sensory loss

About this study

Official title: Lumbal Disk Herniasyonunda Farklı Tedavi Yöntemlerinin Karşılaştırılması

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.

Being tested
non -surgical spinal decompression therapy, deep friction massage,, electrotherapy, exercise
Keywords
exercise, deep friction massage, spinal decompression, non-surgical spinal decompression
Medical subject headings
Intervertebral Disc Displacement, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non -surgical spinal decompression therapyOther

    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

  • electrotherapyOther

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

  • exerciseOther

    special lumbar stabilization exercises were applied in advanced protocol.

Study groups in NCT02572622
Study groupRoleWhat they receive
spinal decompression groupExperimentalonly 15 sessions of spinal decompression therapy were applied.
Receives: Other: non -surgical spinal decompression therapy
combine groupExperimental10 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.
Receives: Other: non -surgical spinal decompression therapy; Other: deep friction massage,; Other: electrotherapy; Other: exercise
exercise groupExperimental10 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
Receives: Other: deep friction massage,; Other: electrotherapy; Other: exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. magnetic resonance imaging changes

    changes recorded in micrometrical measurements.

    Measured: change from baseline in disc height and size of herniation at 3 months.

Secondary outcomes (6)

  1. 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"

    Measured: up to 3 months.

  2. 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.

    Measured: up to 3 months.

  3. 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.

    Measured: up to 3 months.

  4. 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.

    Measured: up to 3 months

  5. 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.

    Measured: up to 3 months.

  6. 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.

    Measured: up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02572622
Sponsor's protocol ID
HacettepeUN
Status last verified
Feb 2016
First submitted
15 Jul 2015
Last updated
24 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20615252

  • 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.

    PubMed 17511872

  • 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.

    PubMed 11411624

  • 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.

    PubMed 16249899

  • 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.

    PubMed 25729196

  • 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.

    PubMed 14715404

  • 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.

    PubMed 20689695

  • 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.

    PubMed 11041196

Questions about this trial

What is this clinical trial studying?

A study testing non -surgical spinal decompression therapy, deep friction massage, and electrotherapy in people with Lumbar Disc Herniation, run by Hacettepe University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

magnetic resonance imaging changes (time frame: change from baseline in disc height and size of herniation at 3 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02572622, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.

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