NCT02572622

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

July 15, 2015

Last Update Submit

February 23, 2016

Conditions

Keywords

exercisedeep friction massagespinal decompressionnon-surgical spinal decompression

Outcome Measures

Primary Outcomes (1)

  • magnetic resonance imaging changes

    changes recorded in micrometrical measurements.

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

Secondary Outcomes (6)

  • disability

    up to 3 months.

  • performance

    up to 3 months.

  • pain

    up to 3 months.

  • straight leg raise test for mobility

    up to 3 months

  • neuropathic pain

    up to 3 months.

  • +1 more secondary outcomes

Study Arms (3)

spinal decompression group

EXPERIMENTAL

only 15 sessions of spinal decompression therapy were applied.

Other: non -surgical spinal decompression therapy

combine group

EXPERIMENTAL

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 therapyOther: deep friction massage,Other: electrotherapyOther: exercise

exercise group

EXPERIMENTAL

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,Other: electrotherapyOther: exercise

Interventions

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

combine groupspinal decompression group

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

combine groupexercise group

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

combine groupexercise group

special lumbar stabilization exercises were applied in advanced protocol.

combine groupexercise group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of lumbar disc herniation without strengthening loss

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 20615252BACKGROUND
  • 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.

    PMID: 17511872BACKGROUND
  • 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.

    PMID: 11411624BACKGROUND
  • 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.

    PMID: 16249899BACKGROUND
  • 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.

    PMID: 25729196BACKGROUND
  • 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.

    PMID: 14715404BACKGROUND
  • 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.

    PMID: 20689695BACKGROUND
  • 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.

    PMID: 11041196BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementMotor Activity

Interventions

Electric Stimulation TherapyExercise

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • aynur demirel, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant Aynur Demirel

Study Record Dates

First Submitted

July 15, 2015

First Posted

October 9, 2015

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02