Low Back PainNCT04475770
Effect of SNAGs on Stiffness of Lumbar Stabilizer Muscles
A study testing Real Sustained Natural Apophyseal Glides (SNAGS) in people with Low Back Pain and Manuel Therapy, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime. Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Manuel Therapy
- What is being tested?
- Real Sustained Natural Apophyseal Glides (SNAGS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 1 Nov 2020
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who diagnosed with non-specific low back pain
- between the ages of 18-24
- patients who able to perform at least 40° of trunk flexion
Who cannot join
- patients who obese, pregnant, had specific low back pain
- indication for surgery in the past 1 year
- the trauma of lumbar region, and systemic inflammatory disease affecting this area
- exercise and conventional physiotherapy in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University
Istanbul, Eyalet/Yerleşke, 34000
About this study
Official title: Effect of Sustained Natural Apophyseal Glides on Stiffness of Lumbar Stabilizer Muscles in Non-specific Low Back Pain Individuals
Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime. Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain.
Low back pain has been shown to alter the structure of deep and superficial muscles such as multifidus and erector spinae. However, it has not been fully explained how changes in muscle fiber structure affect the biomechanical properties and functions of the muscle.
Read more
There are various manual therapy techniques in the treatment of low back pain. Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.
Ultrasound shear wave elastography (SWE) provides an advantage since it can quantitatively assess tissue elasticity of in vivo skeletal muscles through non-invasive high-frequency ultrasound waves.
The aim of this study was to investigate the acute effect of Mulligan SNAGs on the stiffness of muscle tissue by using Ultrasound shear wave elastography which is an objective assessment technique.
- Conditions
- Low Back Pain, Manuel Therapy
- Being tested
- Real Sustained Natural Apophyseal Glides (SNAGS), Sham Sustained Natural Apophyseal Glides (SNAGS)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Sustained Natural Apophyseal Glides (SNAGS)Other
Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.
Sham Sustained Natural Apophyseal Glides (SNAGS)Other
The participants in the Sham SNAGs group will be positioned same as the SNAG group. Mulligan belt will be used, which included the patient's waist and physiotherapist's hip. The physiotherapist will place the hypothenar region of his hand on the spinous processes of the symptomatic lumbar spine levels and waited a few seconds without no glide will be performed. Sham SNAGs practice consisted of 3 sets of 6 repetitions and a 60-second rest period was given between the sets.
| Study group | Role | What they receive |
|---|---|---|
| Real SNAGs | Experimental | Real SNAGs group consists of 16 participants, where the Mulligan concept lumbal SNAGs is applied and evaluations are made before and after. Receives: Other: Real Sustained Natural Apophyseal Glides (SNAGS) |
| Sham SNAGs | Sham comparator | The Sham SNAGs group consists of 16 participants who performed the same positioning as the Real SNAGs group and evaluated twice with a similar interval without any intervention to the spine. Receives: Other: Sham Sustained Natural Apophyseal Glides (SNAGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle stiffness
The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.
Measured: 4 weeks
Secondary outcomes (7)
The sit and reach test
The sit and reach test will be used for back and leg flexibility.
Measured: 4 weeks
Visual Analogue Scale
Pain will be measured with Visual Analogue Scale. Visual Analogue Scale is the most commonly used method for measuring the pain level.
It is scored between 0 and 10. 0 means no pain (minimum score) 10 means I have unbearable pain (maximum score). Higher score means worse result.
Measured: 4 weeks
The Functional Reach Test
The Functional Reach Test will be used to measure standing balance. While the contact surface of the person was in contact with the ground, the distance between the length of the arm and its maximum reach will be measured.
Measured: 4 weeks
The Flamingo Balance Test
The Flamingo Balance Test is total body balance test, and forms part of the Eurofit Testing Battery. This single leg balance test assesses the strength of the leg, pelvic, and trunk muscle as well as dynamic balance. purpose: To assess the ability to balance successfully on a single leg.
Measured: 4 weeks
Lateral bridge test
side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). Similar to the trunk flexor endurance test, this timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine.
Measured: 4 weeks
Trunk extensor endurance
The trunk extensor endurance test is generally used to assess muscular endurance of the torso extensor muscles (i.e., erector spinae, longissimus, iliocostalis, and multifidi). This is a timed test involving a static, isometric contraction of the trunk extensor muscles that stabilize the spine.
Measured: 4 weeks
The Oswestry Disability Index
The functional level will be assessed using The Oswestry Disability Index (ODI) that ıs consist of 10-item. These items assessed pain intensity, personal care, lifting, walking, sitting, sleeping, sex life, and social life. Each item is numbered between from 0 to 5. As the total score increases, the level of disability increases. Each item is number between 0 to 5. As the total score increases, the level of disability increases.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475770
- Sponsor's protocol ID
- 2
- Status last verified
- Sep 2022
- First submitted
- 14 Jul 2020
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sustained Natural Apophyseal Glides on Stiffness of Lumbar Stabilizer Muscles in Non-specific Low Back Pain Individuals
- ClinicalTrials.gov ID
- NCT04475770
- Acronym / sponsor ID
- 2
- Conditions
- Low Back Pain, Manuel Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 17 Jul 2020 (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.
Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime. Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain.
Low back pain has been shown to alter the structure of deep and superficial muscles such as multifidus and erector spinae. However, it has not been fully explained how changes in muscle fiber structure affect the biomechanical properties and functions of the muscle.
There are various manual therapy techniques in the treatment of low back pain. Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.
Ultrasound shear wave elastography (SWE) provides an advantage since it can quantitatively assess tissue elasticity of in vivo skeletal muscles through non-invasive high-frequency ultrasound waves.
The aim of this study was to investigate the acute effect of Mulligan SNAGs on the stiffness of muscle tissue by using Ultrasound shear wave elastography which is an objective assessment technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real SNAGs | Experimental | Other: Real Sustained Natural Apophyseal Glides (SNAGS)Real SNAGs group consists of 16 participants, where the Mulligan concept lumbal SNAGs is applied and evaluations are made before and after. |
| Sham SNAGs | Sham comparator | Other: Sham Sustained Natural Apophyseal Glides (SNAGS)The Sham SNAGs group consists of 16 participants who performed the same positioning as the Real SNAGs group and evaluated twice with a similar interval without any intervention to the spine. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients who diagnosed with non-specific low back pain
- between the ages of 18-24
- patients who able to perform at least 40° of trunk flexion
Key exclusion criteria (4 listed)
- patients who obese, pregnant, had specific low back pain
- indication for surgery in the past 1 year
- the trauma of lumbar region, and systemic inflammatory disease affecting this area
- exercise and conventional physiotherapy in the last 6 months
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 |
|---|---|---|
| Real Sustained Natural Apophyseal Glides (SNAGS)Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment. | Other | Real SNAGs |
| Sham Sustained Natural Apophyseal Glides (SNAGS)The participants in the Sham SNAGs group will be positioned same as the SNAG group. Mulligan belt will be used, which included the patient's waist and physiotherapist's hip. The physiotherapist will place the hypothenar region of his hand on the spinous processes of the symptomatic lumbar spine levels and waited a few seconds without no glide will be performed. Sham SNAGs practice consisted of 3 sets of 6 repetitions and a 60-second rest period was given between the sets. | Other | Sham SNAGs |
Primary outcome
muscle stiffness
Time frame: 4 weeks
The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.
7 secondary outcomes
The sit and reach test
Time frame: 4 weeks
Visual Analogue Scale
Time frame: 4 weeks
The Functional Reach Test
Time frame: 4 weeks
The Flamingo Balance Test
Time frame: 4 weeks
Lateral bridge test
Time frame: 4 weeks
Trunk extensor endurance
Time frame: 4 weeks
The Oswestry Disability Index
Time frame: 4 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 16 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Sustained Natural Apophyseal Glides (SNAGS) in people with Low Back Pain and Manuel Therapy, run by Istinye University 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 4 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 16 Sep 2022. 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. Some participants in this study may receive a placebo. 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?
muscle stiffness (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2022.