Low Back PainNCT03898089
The Effects of Myofascial Release Technique
A study testing Core Stability Exercise and Core Stability Exercise plus Myofascial Release Technique Group in people with Low Back Pain and Exercise, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Low Back Pain, Exercise, Elderly
- What is being tested?
- Core Stability Exercise and Core Stability Exercise plus Myofascial Release Technique Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitation
Kırşehir, 40000
About this study
Official title: The Effects of Myofascial Release Technique Combined With Core Stabilization Training in Elderly With Non-Specific Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain, Exercise, Elderly
- Being tested
- Core Stability Exercise, Core Stability Exercise plus Myofascial Release Technique Group
- Keywords
- Myofascial Release Technique, Core Stabilization Exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stability ExerciseOther
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 Stability Exercise plus Myofascial Release Technique GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Core Stability Exercise plus Myofascial Release Technique Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (10)
Supine Bridge Test
Subjects are asked to lie down and bend their knees in full contact with the floor of the feet. In this position (hooked position) they are asked to lift their hips from the bed. The time for the bridge is measured in seconds after stopping the contact of the hips with the bed.
Measured: 6 weeks
Tampa Scale of Kinesiophobia
This scale is used to assess the patients' fear of pain or re-injury due to movement. It consists of 17 items and assesses various factors of fear/avoidance and injury/re-injury in several activities. Total score of the scale varies between 17 and 68 and higher scores represent higher levels of kinesiophobia.
Measured: 6 weeks
Berg Balance Scale
The scale consists of 14 items that are scored on a scale of 0 to 4. A score of 0 is given if the participant is unable to do the task, and a score of 4 is given if the participant is able to complete the task based on the criterion that has been assigned to it. The maximum total score on the test is 56. The items include simple mobility tasks (eg transfers, standing unsupported, sit-to-stand) and more difficult tasks.
Measured: 6 weeks
Spinal Mobility Assessment
Assessment of spinal mobility with the Spinal Mouse System (Idiag, Fehraltorf, Switzerland), a hand-held, computer-assisted electromechanical device.
Measured: 6 weeks
The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)
The WHOQOL-OLD is a questionnaire consisting of 24 items related to 6 different domains: sensorial operation, autonomy, death and dying past, present and future activities, social participation, and intimacy. Each domain includes 4 items, with each individual score ranging from 1 to 5 and the range of possible marks varying from 5 to 20 for all domains. The scores of the 24 WHOQOL-OLD module items are combined to produce a general score, known as the "total score", indicating the senior citizens' quality of life reports, ranging from 24 to 120.
Measured: 6 weeks
Gait Cycle Assessment
Assessment of gait cycle with device (Biodex Gait Trainer 2, Biodex Medical Systems Inc, US). Gait cycle (sec) is determined by walking subjects on the gait trainer for 6 minute.
Measured: 6 weeks
Walking Speed Assessment
Assessment of walking speed with device (Biodex Gait Trainer 2, Biodex Medical Systems Inc, US). Walking speed (m/sec) is determined by walking subjects on the gait trainer for 6 minute.
Measured: 6 weeks
Maximum Walking Distance Assessment
Assessment of maximum walking distance with device (Biodex Gait Trainer 2, Biodex Medical Systems Inc, US). Maximum walking distance (m) is determined by walking subjects on the gait trainer for 6 minute.
Measured: 6 weeks
Step Length Assessment
Assessment of step length with device (Biodex Gait Trainer 2, Biodex Medical Systems Inc, US). Step length (cm) is determined by walking subjects on the gait trainer for 6 minute.
Measured: 6 weeks
Ambulation Index Assessment
Assessment of ambulation index with device (Biodex Gait Trainer 2, Biodex Medical Systems Inc, US). Ambulation index score is determined by walking subjects on the gait trainer for 6 minute.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Mar 2019
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail OZSOY, Ahi Evran University Education and Research Hospital
- Investigators
- Ismail Ozsoy, PhD, Principal investigator, Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898089
- Sponsor's protocol ID
- 2019100
- Status last verified
- Jul 2020
- First submitted
- 28 Mar 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31631992
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Myofascial Release Technique Combined With Core Stabilization Training in Elderly With Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT03898089
- Acronym / sponsor ID
- 2019100
- Conditions
- Low Back Pain, Exercise, Elderly
- Keywords
- Myofascial Release Technique, Core Stabilization Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Core Exercise Group | Other | Other: Core Stability ExerciseThe participants in the core stability exercise group will be included in a treatment program for 3 days per week for 6 weeks. |
| Core Exercise plus Myofascial Relaxation Group | Experimental | Other: Core Stability Exercise plus Myofascial Release Technique GroupIn 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. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Stability ExerciseThe 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. | Other | Core Exercise Group |
| Core Stability Exercise plus Myofascial Release Technique GroupIn 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. | Other | Core Exercise plus Myofascial Relaxation Group |
Primary outcome
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."
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.
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.
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.
10 secondary outcomes
Supine Bridge Test
Time frame: 6 weeks
Tampa Scale of Kinesiophobia
Time frame: 6 weeks
Berg Balance Scale
Time frame: 6 weeks
Spinal Mobility Assessment
Time frame: 6 weeks
The World Health Organization Quality of Life Instrument-Older Adults Module (WHOQOL-OLD)
Time frame: 6 weeks
Gait Cycle Assessment
Time frame: 6 weeks
Walking Speed Assessment
Time frame: 6 weeks
Maximum Walking Distance Assessment
Time frame: 6 weeks
Step Length Assessment
Time frame: 6 weeks
Ambulation Index Assessment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 31631992Ozsoy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Ozsoy, PhD principal investigator
Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stability Exercise and Core Stability Exercise plus Myofascial Release Technique Group in people with Low Back Pain and Exercise, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.