Clinical trial NCT02699164: Remission of Lumbar Disc Herniation by Physiotherapy
Official title: Lumbal Disk Herniasyonunda farklı Tedavi yöntemlerinin etkinliğinin karşılaştırılması
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: non surgical spinal decompression therapy
deep friction massage
exercise
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: herniation thickness
timeFrame: change from baseline in herniation thickness and disc height at three months
Secondary outcomes:
measure: function
timeFrame: up to 3 months
measure: mobility
timeFrame: up to 3 months
measure: pain severity
timeFrame: change form baseline in pain severity at 15 sessions of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Aynur Demirel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Nevin Ergun, Proff
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem Hospital
name: Mehmet Yorubulut, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.2519/jospt.2001.31.6.291.
citation: 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.
citation: 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.
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 Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Apr 20;33(9):991-8. doi: 10.1097/BRS.0b013e31816c8379.
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. 2006 Nov 22;296(20):2441-50. doi: 10.1001/jama.296.20.2441.
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.
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: 10.3109/09638288.2010.533814. Epub 2010 Nov 20.
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.