Remission of Lumbar Disc Herniation by Physiotherapy

NCT ID: NCT02699164

Last Updated: 2016-08-16

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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This study was conducted with the aim of determining whether or not Non surgical spinal decompression therapy was effective in remission of herniation, decreasing pain and improving functional status.

Detailed Description

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Both groups received combination of electrotherapy, deep friction massage and stabilization exercise for fifteen session.

Combine group received non surgical spinal decompression therapy (NSDT) different from conventional physiotherapy group. Numeric Analog Scale, Straight leg raise (SLR) test, Oswestry Disability Index (ODI) were applied at baseline and after treatment. Disc height and herniation thickness were measured on Magnetic Resonance Imagination (MRI) which performed at baseline and three months after therapy.

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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combine group

Conventional physiotherapy applied 15 sessions of treatment. In addition to conventional physiotherapy non-surgical spinal decompression therapy applied.

First 10 sessions of treatment non-surgical decompression therapy applied and last 5 sessions spinal stabilization exercise applied.

Group Type EXPERIMENTAL

DRX 9000, Axiom Worldwide, Tampa, Florida

Intervention Type DEVICE

non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).

physiotherapy

Intervention Type OTHER

electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.

spinal stabilization exercise

Intervention Type OTHER

spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.

conventional physiotherapy

conventional physiotherapy applied 15 sessions of treatment. Conventional physiotherapy consisted hotpack, Transcutaneal Electric Nerve Stimulation(TENS) and Ultrasound Currents. Spinal stabilization exercises applied last five sessions of therapy.

Group Type EXPERIMENTAL

physiotherapy

Intervention Type OTHER

electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.

spinal stabilization exercise

Intervention Type OTHER

spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.

Interventions

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DRX 9000, Axiom Worldwide, Tampa, Florida

non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).

Intervention Type DEVICE

physiotherapy

electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.

Intervention Type OTHER

spinal stabilization exercise

spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

diagnosed as lumbar disc herniation suffering from low back pain at least 8 weeks

Exclusion Criteria

undergone any spinal surgery clinical diagnosis of osteoporosis clinical diagnosis of scoliosis and spondylolisthesis any neurological disease causes sensorial 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 asisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aynur Demirel, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Nevin Ergun, Proff

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Mehmet Yorubulut, MD

Role: PRINCIPAL_INVESTIGATOR

Acıbadem Hospital

References

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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)

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 RESULT
PMID: 20615252 (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 RESULT
PMID: 20689695 (View on PubMed)

Lurie JD, Tosteson AN, Tosteson TD, Carragee E, Carrino JA, Kaiser J, Sequeiros RT, Lecomte AR, Grove MR, Blood EA, Pearson LH, Herzog R, Weinstein JN. Reliability of magnetic resonance imaging readings for lumbar disc herniation in the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Apr 20;33(9):991-8. doi: 10.1097/BRS.0b013e31816c8379.

Reference Type RESULT
PMID: 18427321 (View on PubMed)

Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, Hilibrand AS, Boden SD, Deyo RA. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.

Reference Type RESULT
PMID: 17119140 (View on PubMed)

Romanowski M, Romanowska J, Grzeskowiak M. A comparison of the effects of deep tissue massage and therapeutic massage on chronic low back pain. Stud Health Technol Inform. 2012;176:411-4.

Reference Type RESULT
PMID: 22744541 (View on PubMed)

Hahne AJ, Ford JJ, Hinman RS, Taylor NF, Surkitt LD, Walters AG, McMeeken JM. Outcomes and adverse events from physiotherapy functional restoration for lumbar disc herniation with associated radiculopathy. Disabil Rehabil. 2011;33(17-18):1537-47. doi: 10.3109/09638288.2010.533814. Epub 2010 Nov 20.

Reference Type RESULT
PMID: 21091049 (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 RESULT
PMID: 25729196 (View on PubMed)

Other Identifiers

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GO14-265

Identifier Type: -

Identifier Source: org_study_id

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