Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

NCT ID: NCT02572622

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lumbar Disc Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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spinal decompression group

only 15 sessions of spinal decompression therapy were applied.

Group Type EXPERIMENTAL

non -surgical spinal decompression therapy

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

non -surgical spinal decompression therapy

Intervention Type 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,

Intervention Type OTHER

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

electrotherapy

Intervention Type OTHER

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

exercise

Intervention Type OTHER

special lumbar stabilization exercises were applied in advanced protocol.

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

Group Type EXPERIMENTAL

deep friction massage,

Intervention Type OTHER

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

electrotherapy

Intervention Type OTHER

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

exercise

Intervention Type OTHER

special lumbar stabilization exercises were applied in advanced protocol.

Interventions

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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.

Intervention Type OTHER

deep friction massage,

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

Intervention Type OTHER

electrotherapy

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

Intervention Type OTHER

exercise

special lumbar stabilization exercises were applied in advanced protocol.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Aynur Demirel

research assistant Aynur Demirel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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aynur demirel, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

References

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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.

Reference Type BACKGROUND
PMID: 20615252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17511872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11411624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16249899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25729196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14715404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20689695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11041196 (View on PubMed)

Other Identifiers

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HacettepeUN

Identifier Type: -

Identifier Source: org_study_id

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