Comparison of Different Treatment Methods in Lumbal Disc Herniation Treatment

Lumbar Disc Herniation Clinical Trial

Official title:

Lumbal Disk Herniasyonunda Farklı Tedavi Yöntemlerinin Karşılaştırılması

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572622
• Other study ID #: HacettepeUN
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: February 23, 2016
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Other:
• 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.
• deep friction massage,
deep friction massage is a kind of massage targeting deep muscles for decreasing pain and increasing function
• electrotherapy
electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.
• exercise
special lumbar stabilization exercises were applied in advanced protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

References & 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. — View Citation

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. — View Citation

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. — View Citation

Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. Review. Erratum in: Pain. 2004 May;109(1-2):200-1. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2005 Oct 25. — View Citation

Schoenfeld AJ, Weiner BK. Treatment of lumbar disc herniation: Evidence-based practice. Int J Gen Med. 2010 Jul 21;3:209-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	magnetic resonance imaging changes	changes recorded in micrometrical measurements.	change from baseline in disc height and size of herniation at 3 months.	No
Secondary	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"	up to 3 months.	No
Secondary	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.	up to 3 months.	No
Secondary	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.	up to 3 months.	No
Secondary	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.	up to 3 months	No
Secondary	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.	up to 3 months.	No
Secondary	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.	up to 3 months.	No