Chronic Low-back PainNCT05623735

Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back Pain

A study testing Instrument Assisted Soft Tissue Mobilization Group While Lying Prone and Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement in people with Chronic Low-back Pain, run by Eastern Mediterranean University at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to determine whether the effectiveness of instrument-assisted soft tissue mobilization technique is different from passive prone lying when performed with a functional exercise in individuals with chronic nonspecific low back pain. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Chronic Low-back Pain
What is being tested?: Instrument Assisted Soft Tissue Mobilization Group While Lying Prone and Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteCyprus
Study dates: 20 Nov 2022to 2 Feb 2023
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Being diagnosed with non-specific low back pain by a specialist physician
18-45 years old
Having 3 or more pains on VAS for the last 3 months.
Those who do not use analgesic drugs
Not taking physiotherapy for the last 6 months.

Who cannot join

Those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer)
Those with a history of spinal surgery
Pregnant and lactating
Open wound, infection, serious kidney disease
Those who have limited hip joint movements

Trial locations and contacts

1 site in 1 country.

Cyprus1 site

Süleyman Güzelşemme
Famagusta, 99628

Other trials in Cyprus

About this study

Official title: Comparison of the Effects of Two Different Instrument Assisted Soft Tissue Mobilization Techniques in Individuals With Chronic Non-Specific Low Back Pain

Read the detailed description

Individuals participating in the study will first be divided into two groups by randomization. While IASTM (Instrument Assisted Soft Tissue Mobilization Techniques) will be applied to one group in the prone position, IASTM will be applied to the other group with functional exercise. The pain, mobility, flexibility, disability and endurance parameters of the individuals assigned to the groups after randomization will be determined just before the application, immediately after the 1st application and immediately after the 6th application. The study will last for a total of 6 sessions, with two sessions per week for 3 weeks.

Conditions: Chronic Low-back Pain
Being tested: Instrument Assisted Soft Tissue Mobilization Group While Lying Prone, Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement
Keywords: IASTM, chronic pain, flexibility, disability, mobility, muscular endurance
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Instrument Assisted Soft Tissue Mobilization Group While Lying ProneOther
1. Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments.
2. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles.
3. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds.
4. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial.
5. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds.
6. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles.
7. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.
Instrument Assisted Soft Tissue Mobilization Group Combined with Functional MovementOther
1. Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments.
2. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles.
3. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds.
4. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial.
5. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds.
6. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles.
7. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.

Study groups in NCT05623735
Study group	Role	What they receive
Instrument Assisted Soft Tissue Mobilization (IASTM) Group While Lying Prone	Experimental	The application will take a total of 6 sessions, with two sessions per week for 3 weeks. While individuals are lying in the prone position, the IASTM protocol will be applied bilaterally on the erector spinae and then on the hamstrings. The application will take approximately 17 minutes. Receives: Other: Instrument Assisted Soft Tissue Mobilization Group While Lying Prone
Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement	Experimental	While standing in the "extended child pose (utthita balasana)" stance, the "IASTM" protocol will be applied bilaterally on the lumbar erector spines, with the hands on them and moving back to the old position. Then, the "IASTM" protocol will be applied bilaterally on the hamstrings by making consecutive knee flexion-extension up to 90 degrees while the individuals are lying prone. The application will take approximately 17 minutes. Receives: Other: Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analog Scale (VAS)
Individuals' pain levels will be measured using the Visual Analogue Scale (VAS) both at rest and during activity. It will be requested to mark any point on a horizontal line of 10 cm length such that 0 no pain, 10 unbearably severe pain.
Measured: 3 Weeks

Secondary outcomes (5)

Mobility (Modified Schober Test)
Individuals' spinal mobility will be assessed using the Modified Schober Test. While the patient is standing, the midpoint between the spina iliaca posterior superior is marked. This point is considered the L4-L5 level. Two more points are marked 10 cm above and 5 cm below this point. This distance will be measured both while standing and by asking them to bend forward without bending the knees, with the hands touching the feet.
Measured: 3 Weeks
Flexibility (Sit and Reach Test)
A measuring bench with a length of 55 cm in the upper part, 35 cm in the lower part, 32 cm in height and 45 cm in width will be used. The soles of both lower extremities will be fully touching the bench with bare feet and the patient will be asked to lie on the bench with knees extended straight and hands on top of each other. The level of the feet will be the 0 point on the table at the top. It will be recorded in such a way that it extends forward +, lagging behind -. The test will be calculated by taking the best value of the measurements after 3 consecutive repetitions.
Measured: 3 Weeks
Flexibility (Maximal Hip Flexion Active Knee Extension (MHFAKE))
Hamstring flexibility will be measured using the Active Knee Extension Test with Maximal Hip Flexion (MHFAKE). It has been reported to be the best measure of hamstring flexibility compared to traditional straight leg raises or other tests. While the individual is lying in the supine position, he will be asked to take the hip of the tested extremity to its maximal flexion and lock it with his hands, then actively bring the knee to the extension position until it reaches the maximal tension it can reach. The contralateral limb will be extended straight on the bed. To prevent variations, the contralateral extremity will be fixed to the bed from the distal thigh with a belt. Knee angle will be measured with a goniometer.
Measured: 3 Weeks
Disability (Oswestry Disability İndex)
The Turkish version of the Oswestry Low Back Pain Disability Questionnaire consisting of 10 questions will be used in order to measure the loss of function caused by low back pain. These questions are; It consists of questions compatible with daily life activities such as pain intensity, personal care, lifting/carrying, walking, sitting, standing, sleep, travel, social life, and degree of pain change. Higher scores mean more disability.
Measured: 3 Weeks
Trunk Extensors Muscle Endurance (Biering-Sorenson Test)
The trunk extensors muscle endurance of individuals will be evaluated with the Biering Sorenson test. Individuals will be asked to lie face down on the bed and extend their torso out of the bed from the anterior superior iliac spine (SIAS). A rolled towel will be placed in front of the ankle and their legs will be supported by the physiotherapist. Individuals will be asked to stand with their hands crossed in the pectoral region and keep their torso parallel to the ground against gravity. The time will be recorded in seconds.
Measured: 3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20222 Feb 2023

First posted21 Nov 2022
Study start20 Nov 2022
Primary completion20 Jan 2023
Study completion2 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic 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
Masking: Single blind
Who is masked: Participant
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05623735
Sponsor's protocol ID: ETK00-2022-0173
Status last verified: Feb 2023
First submitted: 14 Nov 2022
Last updated: 15 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
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
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effects of Two Different Instrument Assisted Soft Tissue Mobilization Techniques in Individuals With Chronic Non-Specific Low Back Pain
ClinicalTrials.gov ID: NCT05623735
Acronym / sponsor ID: ETK00-2022-0173
Conditions: Chronic Low-back Pain
Keywords: IASTM, chronic pain, flexibility, disability, mobility, muscular endurance
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Eastern Mediterranean UniversityUniversity, hospital or other
Study start: 20 Nov 2022 (actual)
Primary completion: 20 Jan 2023 (actual)
Study completion: 2 Feb 2023 (actual)
First posted: 21 Nov 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Instrument Assisted Soft Tissue Mobilization (IASTM) Group While Lying Prone	Experimental	Other: Instrument Assisted Soft Tissue Mobilization Group While Lying ProneThe application will take a total of 6 sessions, with two sessions per week for 3 weeks. While individuals are lying in the prone position, the IASTM protocol will be applied bilaterally on the erector spinae and then on the hamstrings. The application will take approximately 17 minutes.
Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement	Experimental	Other: Instrument Assisted Soft Tissue Mobilization Group Combined with Functional MovementWhile standing in the "extended child pose (utthita balasana)" stance, the "IASTM" protocol will be applied bilaterally on the lumbar erector spines, with the hands on them and moving back to the old position. Then, the "IASTM" protocol will be applied bilaterally on the hamstrings by making consecutive knee flexion-extension up to 90 degrees while the individuals are lying prone. The application will take approximately 17 minutes.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Being diagnosed with non-specific low back pain by a specialist physician
18-45 years old
Having 3 or more pains on VAS for the last 3 months.
Those who do not use analgesic drugs
Not taking physiotherapy for the last 6 months.

Key exclusion criteria (5 listed)

Those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer)
Those with a history of spinal surgery
Pregnant and lactating
Open wound, infection, serious kidney disease
Those who have limited hip joint movements

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
Instrument Assisted Soft Tissue Mobilization Group While Lying Prone1. Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments. 2. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 3. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds. 4. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial. 5. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds. 6. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 7. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.	Other	Instrument Assisted Soft Tissue Mobilization (IASTM) Group While Lying Prone
Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement1. Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments. 2. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 3. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds. 4. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial. 5. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds. 6. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 7. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.	Other	Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement

Primary outcome

Visual Analog Scale (VAS)
Time frame: 3 Weeks
Individuals' pain levels will be measured using the Visual Analogue Scale (VAS) both at rest and during activity. It will be requested to mark any point on a horizontal line of 10 cm length such that 0 no pain, 10 unbearably severe pain.

5 secondary outcomes

Mobility (Modified Schober Test)
Time frame: 3 Weeks
Flexibility (Sit and Reach Test)
Time frame: 3 Weeks
Flexibility (Maximal Hip Flexion Active Knee Extension (MHFAKE))
Time frame: 3 Weeks
Disability (Oswestry Disability İndex)
Time frame: 3 Weeks
Trunk Extensors Muscle Endurance (Biering-Sorenson Test)
Time frame: 3 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 15 Feb 2023.

Related trials for Chronic Low-back Pain

Not yet recruiting
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
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

Süleyman Güzelşemme, Res. Asst. principal investigator

Eastern Mediterranean University

Sevim Öksüz, Asst. Prof. study director

Eastern Mediterranean University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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 15 Feb 2023. 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 Cyprus. 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 Analog Scale (VAS) (time frame: 3 Weeks). 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 NCT05623735.

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 15 Feb 2023.