Clinical trial NCT03898089: The Effects of Myofascial Release Technique
Official title: The Effects of Myofascial Release Technique Combined With Core Stabilization Training in Elderly With Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Exercise
Elderly
Keywords: Myofascial Release Technique
Core Stabilization Exercise
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 6 weeks
measure: Pain Pressure Threshold
timeFrame: 6 weeks
measure: The Oswestry Disability Index
timeFrame: 6 weeks
measure: Chair Sit and Reach Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Supine Bridge Test
timeFrame: 6 weeks
measure: Tampa Scale of Kinesiophobia
timeFrame: 6 weeks
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: Spinal Mobility Assessment
timeFrame: 6 weeks
measure: The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)
timeFrame: 6 weeks
measure: Gait Cycle Assessment
timeFrame: 6 weeks
measure: Walking Speed Assessment
timeFrame: 6 weeks
measure: Maximum Walking Distance Assessment
timeFrame: 6 weeks
measure: Step Length Assessment
timeFrame: 6 weeks
measure: Ambulation Index Assessment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitation
Study officials:
affiliation: Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitation
name: Ismail Ozsoy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.