Clinical trial NCT04061759: Physiotherapy in Lumbar Disc Pathologies
Official title: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Disease
Lumbar Disc Herniation
Low Back Pain, Mechanical
Low Back Strain
Lead sponsor: Guven Health Group
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effectiveness of four physical therapy treatment approaches for lumbar region pathologies. Eighty volunteers who have back pain will be included in the study. Subjects will be randomly divided into four groups; Group 1: Soft tissue mobilisation techniques and stabilization exercises (n=20), Group 2: Kinesiotape and stabilization exercise (n=20), Group 3: Stabilization exercises (n=20), Group 4: Reflexology and stabilization exercises (n=20).

Detailed description: All patients will be measured with visual analog scale for pain level, goniometric measurement for range of motion, hamstring tension and sit and reach for flexibility, isokinetic evaluation for strength in 60degree/ sec, Side plank position test for trunk stabilization.

Function will be measured with Oswestry Disability Index. Manual muscle testing for flexion, extension, lateral flexion of back, flexion, extension, abduction of hip, flexion, extension of knee and inversion, eversion of ankle will be assessed. Group 1, 2 and 4 will be started to treatment twice a week for 4 weeks after first evaluation. Group 3 will be had home exercise programme after first evaluation.

Groups will be assessed again at 4th and 8th weeks after treatment. Multiway variant analysis will bee done within each group before the treatment and at follow-up. When differences observed, Tukey test will be used to find out the group that caused the differences.

Eligibility criteria: Inclusion Criteria:

* The participants between the ages of 25 and 55 years,
* Having a minimum pain level (at activity) of 3 out of 10 on visual analog scale
* Having low back pain for at least 3 months with lumbar disc pathology (bulging or protrusion) diagnosed by clinical tests and magnetic resonance imaging.

Exclusion criteria:

* sacroiliac and lumbar degenerative pathologies,
* another pathology related to neurological deficits,
* physiotherapy previously received for at least 12 months,
* any surgery affecting the lumbar region.

Primary outcomes:
measure: pain intensity
timeFrame: 8weeks
measure: range of motion
timeFrame: 8weeks
measure: muscular strength
timeFrame: 8weeks
measure: Trunk stabilization test
timeFrame: 8weeks
measure: Functional performance
timeFrame: 1hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Anima Rapha Center
Study officials:
affiliation: Guven Health Group
name: Yesim Sardan Cetinkaya, MD
role: STUDY_DIRECTOR
References:
citation: Standaert CJ, Weinstein SM, Rumpeltes J. Evidence-informed management of chronic low back pain with lumbar stabilization exercises. Spine J. 2008 Jan-Feb;8(1):114-20. doi: 10.1016/j.spinee.2007.10.015.
citation: Burns SA, Cleland JA, Rivett DA, Snodgrass SJ. Effectiveness of physical therapy interventions for low back pain targeting the low back only or low back plus hips: a randomized controlled trial protocol. Braz J Phys Ther. 2018 Sep-Oct;22(5):424-430. doi: 10.1016/j.bjpt.2018.08.014. Epub 2018 Sep 7.
citation: Burns SA, Cleland JA, Cook CE, Bade M, Rivett DA, Snodgrass S. Variables Describing Individuals With Improved Pain and Function With a Primary Complaint of Low Back Pain: A Secondary Analysis. J Manipulative Physiol Ther. 2018 Jul-Aug;41(6):467-474. doi: 10.1016/j.jmpt.2017.11.006. Epub 2018 Aug 9.