The Effects of Myofascial Release Technique

NCT03898089 | Completed

• 1 other identifier: 2019100
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Exercise; Elderly

Keywords

Myofascial Release Technique; Core Stabilization Exercise

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale

  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."

  6 weeks

• Pain Pressure Threshold

  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.

  6 weeks

• The Oswestry Disability Index

  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.

  6 weeks

• Chair Sit and Reach Test

  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.

  6 weeks

Secondary Outcomes (10)

• Supine Bridge Test

  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

Study Arms (2)

Core Exercise Group

OTHER

The participants in the core stability exercise group will be included in a treatment program for 3 days per week for 6 weeks.

Other: Core Stability Exercise

Core Exercise plus Myofascial Relaxation Group

EXPERIMENTAL

In addition to the core stabilization exercises myofascial relaxation technique will be performed with roller massager (Theraband®, The Hygenic Corporation, Akron, OH.) for 3 days per week for 6 weeks.

Other: Core Stability Exercise plus Myofascial Release Technique Group

Interventions

Core Stability Exercise OTHER

The participants in the core stability exercise group will be included in a treatment program for 3 days per week for 6 weeks. 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).Each training session will be lasted 60 min, starting with a 10-min warm up program mainly consisting of core strength exercises and ending with a 5-min cool-down program (stretching). Progression of exercises will be tailored to individual patients' ability, fatigue and pain. Exercises will be designed from 1 set to 3 sets, from 8 to 15 repetitions and contractions from 5 seconds to 10 seconds.

Core Exercise Group

Core Stability Exercise plus Myofascial Release Technique Group OTHER

In addition to the core stabilization exercise group myofascial relaxation technique will be performed with roller massager (Theraband®, The Hygenic Corporation, Akron, OH.) for 3 days per week for 6 weeks. The myofascial relaxation technique will be performed along the superficial back line (plantar fascia gastrocnemius muscles, hamstring muscles, sacrolumbar fascia, erector spinae muscles) bilaterally. Myofascial relaxation will be done to the anatomical structures indicated by roller massage technique. Applications will be made in 3 sets of 30sec for each zone (1 min rest between sets) and 7/10 according to VAS.

Core Exercise plus Myofascial Relaxation Group

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitation

Kırşehir, 40000, Turkey (Türkiye)

Location

Related Publications (1)

• Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.

  PMID: 31631992 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Ismail Ozsoy, PhD

  Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: March 1, 2019
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

TU (1)