Remission of Lumbar Disc Herniation by Physiotherapy

Lumbar Disc Herniation Clinical Trial

Official title:

Lumbal Disk Herniasyonunda farklı Tedavi yöntemlerinin etkinliğinin karşılaştırılması

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699164
• Other study ID #: GO14-265
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: August 15, 2016
• Start date: January 2014
• Est. completion date: June 2015

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• 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:

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

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

Device:
• 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).

Other:
• physiotherapy
electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.
• spinal stabilization exercise
spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.

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 Mu — 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.2 — View Citation

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. — 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

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 Outc — View Citation

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. — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	herniation thickness	herniation thickness were measured on MRI.	change from baseline in herniation thickness and disc height at three months	No
Secondary	function	Oswestry Disability Index was used.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	mobility	straight leg raise test was used. Pain free angle of straight leg raise was measured with goniometer.	up to 3 months	No
Secondary	pain severity	numeric analog scale was used. "0" described no pain, "10" described "unbearable pain".	change form baseline in pain severity at 15 sessions of treatment	No