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Clinical Trials/NCT03898089
NCT03898089
Completed
Not Applicable

The Effects of Myofascial Release Technique Combined With Core Stabilization Training in Elderly With Non-Specific Low Back Pain

Ahi Evran University Education and Research Hospital1 site in 1 country36 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Ahi Evran University Education and Research Hospital
Enrollment
36
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study is designed as a single blind randomized controlled trial. Thirty-six elderly with non-specific low back pain (NSLBP) will be recruited. The participants will randomly divided two parallel groups as control and intervention. Traditional physiotherapy methods will be applied to all participants. Traditional physiotherapy will include heat modality (a hot pack for 15 minutes), electrotherapy (transcutaneous electrical nerve stimulation (TENS), a 50 Hz conventional TENS with a pulse duration <150 microseconds). For the control group, core stability exercise will be applied 3 days/week, 6 weeks. For the intervention group, in addition to the core stabilization exercises myofascial relaxation technique will be performed with roller massager ((Thera-Band; The Hygenic Corporation, Akron, OH) 3 days/week, 6 weeks. The myofascial relaxation technique will be performed along the superficial back line. To the best of our knowledge, there is no randomized controlled study investigating the effect of the myofascial release technique combined with core stabilization in elderly with NSLBP. This study aimed to investigate the myofascial release technique combined with core stabilization exercise in elderly with NSLBP.

Detailed Description

Low back pain is a symptom that is an important health problem throughout the world. Non-specific low back pain (NSLBP) is the most widespread form of the low back pain. The NSLBP is called low back pain without recognisable specific underlying pathology. The lifetime prevalence of low back pain is up to 84%. The prevalence and burden the low back pain of increases with aging. The use of various methods of non-pharmacological and non-invasive especially exercise, mobilization, and manipulation in low back pain. Core stability exercise is a common exercise modality in the treatment of low back pain. Core stability exercises improve trunk strength and low back disability in elderly with NSLBP. However, the studies have showed that decreasing strength in the deep muscles (such as the transverse abdominis and multifidus) is accompanied by increased activation in the superficial muscles (such as the erector spina) in patients with low back pain. Therefore, myofascial release technique on superficial muscles can be effective in NSLBP. To the best of our knowledge, there is no randomized controlled study investigating the effect of the myofascial release technique combined with core stabilization in elderly with NSLBP. Therefore, this study aimed to investigate the myofascial release technique combined with core stabilization exercise in elderly with NSLBP.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
August 15, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ahi Evran University Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ismail OZSOY

Principal Investigator

Ahi Evran University Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Ongoing low back pain for at least 3 months
  • Having no neurological, rheumatological or musculoskeletal problems
  • Standardized Mini-Mental State score greater than or equal to 24 points

Exclusion Criteria

  • Low back pain originating from various pathologies
  • Presence of cord compression,
  • Radiculopathy,
  • Osteoporosis or osteopenia (t score\>-1),
  • Long-term use of anticoagulant or corticosteroid drugs,
  • Patients who had received any treatment for their low back pain.

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: 6 weeks

The visual analog scale is a validated, subjective measure for pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

The Oswestry Disability Index

Time Frame: 6 weeks

It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.

Pain Pressure Threshold

Time Frame: 6 weeks

An electronic pressure algometer (Algometer commander, JTech Medical, Line; Salt Lake City) is used to measure pressure pain threshold (PPT) with a stimulation surface area of 1 cm2. Three consecutive measurements are performed at each site, with 10 seconds of recovery time allowed between repeated applications. During the algometric measurements, the subjects are asked to say "yes" when the pain is experienced. The amount of pressure-causing pain is recorded as PPT in kg/ cm2. The subjects are required to lie down in a prone position for the measurements. 2 lumbar paravertebral points (bilateral 5 cm lateral to the L3 spinous processes) are evaluated.

Chair Sit and Reach Test

Time Frame: 6 weeks

Subjects are asked to sit at the edge of a chair with one leg extend forward with knee straight, heel on the floor and ankle bended as 90o , while the other foot remained flat on the floor. Subjects are instructed to place one hand over the other hand with the middle finger tips even, and tried to reach forward to the toe of the extended leg. The distance between the middle finger tips and the toe are recorded.

Secondary Outcomes

  • Supine Bridge Test(6 weeks)
  • Walking Speed Assessment(6 weeks)
  • Ambulation Index Assessment(6 weeks)
  • Tampa Scale of Kinesiophobia(6 weeks)
  • Berg Balance Scale(6 weeks)
  • Spinal Mobility Assessment(6 weeks)
  • The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)(6 weeks)
  • Gait Cycle Assessment(6 weeks)
  • Maximum Walking Distance Assessment(6 weeks)
  • Step Length Assessment(6 weeks)

Study Sites (1)

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