Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment
Lumbal Disk Herniasyonunda Farklı Tedavi Yöntemlerinin Karşılaştırılması
1 other identifier
interventional
30
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedFebruary 24, 2016
February 1, 2016
1.3 years
July 15, 2015
February 23, 2016
Conditions
Keywords
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
EXPERIMENTALonly 15 sessions of spinal decompression therapy were applied.
combine group
EXPERIMENTAL10 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.
exercise group
EXPERIMENTAL10 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
Interventions
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 is a kind of massage targeting deep muscles for decreasing pain and increasing function
electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.
special lumbar stabilization exercises were applied in advanced protocol.
Eligibility Criteria
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: 20615252BACKGROUNDDaniel 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: 17511872BACKGROUNDLundon 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: 11411624BACKGROUNDOzturk 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: 16249899BACKGROUNDChoi 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: 25729196BACKGROUNDLiddle 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: 14715404BACKGROUNDSchoenfeld 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: 20689695BACKGROUNDMeszaros 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
aynur demirel, PhD
Hacettepe University
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