Instrument-assisted Soft Tissue MobilizationNCT05503602
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application in Individuals With Chronic Non-Specific Neck Pain.
A study testing Classical Physiotherapy, IASTM Technique Application and Foam Roller Technique Application in people with Instrument-assisted Soft Tissue Mobilization and Flexibility, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Neck pain is in fourth place among the pathologies that result in the state of disability. Acute neck pain improves greatly within 2 months, while neck pain that persists for more than 3 months takes the form of chronic neck pain. Pain adversely affects people's activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Foam Roller
- What is being tested?
- Classical Physiotherapy, IASTM Technique Application and Foam Roller Technique Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Oct 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Consists of individuals between the ages of 18-60,
- Being diagnosed with chronic non-specific neck pain,
- Having a score of at least 4 on the visual analog scale (VAS) of the mean neck pain intensity,
- Having non-specific neck pain at least 5 days a week for the last 12 weeks,
- To be deemed appropriate by the physical therapy physician for early physiotherapy treatment after the diagnosis of chronic non-specific neck pain.
Who cannot join
- Individuals with a history of cervical spine surgery, cervical trauma, central nervous system diseases, cervical radiculopathy, acute inflammation and malignancy,
- Having neck pain due to specific causes (disc protrusion, radicular syndrome, whiplash, congenital deformity of the spine, spinal canal stenosis and neoplasm),
- Individuals with inflammatory rheumatic disease, active oncological disease, affective disorder, addiction and psychosis,
- Individuals who have undergone invasive treatment of the spine in the last 4 weeks or spine surgery in the previous 12 months,
- Individuals from the chronic neck pain group who are currently receiving treatment or have a neck injury resulting in a spinal fracture,
- Individuals who have started a new treatment for neck pain in the past month or are planning to start a new treatment within 9 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application on Strength, Flexibility, Pain and Secondary Outcome Measures in Individuals With Chronic Non-Specific Neck Pain.
Neck pain is in fourth place among the pathologies that result in the state of disability. Acute neck pain improves greatly within 2 months, while neck pain that persists for more than 3 months takes the form of chronic neck pain. Pain adversely affects people's activities of daily living. Treatment applications such as electrotherapy, hot and cold applications are applied for purposes such as reducing pain and muscle spasm and correcting functions. In addition to such treatment options, instrument-assisted soft tissue mobilization (IASTM) and foam roller therapy have been started to be applied in many disease groups in recent years and have attracted great attention. iASTM and Foam Roller is a technique that involves the use of tools in disorders of musculoskeletal pathology and to help heal soft tissues.
The aim of this study is to investigate the effects of foam roller technique with instrument-assisted soft tissue mobilization technique in individuals of different ages with chronic non-specific neck pain. According to the data obtained, the techniques the investigators will use, together with physiotherapy programs, contribute to the treatment of individuals with chronic non-specific neck pain and to the literature.is expected to provide.
Read the detailed description
In the study, Foam Roller will be applied to individuals with chronic non-specific neck pain with iASTM and the effect of these techniques will be examined. Demographic information of individuals will be recorded; individuals will be evaluated in detail in terms of muscle strength, flexibility, pain and secondary outcome measures. Individuals in terms of secondary outcome measures; functional status,joint range of motion and quality of life will be evaluated.
The work plan; pre-treatment evaluation, followed by treatment, second evaluation immediately after the end of treatment and control evaluation (third evaluation) 1 month after the end of treatment. The data collection period is planned as 1 year.
- Conditions
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Foam Roller, Strength, Chronic Non-specific Neck Pain
- Being tested
- Classical Physiotherapy, IASTM Technique Application, Foam Roller Technique Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical PhysiotherapyOther
Only classical physiotherapy application, 5 sessions per week for 4 weeks.
IASTM Technique ApplicationOther
Instrument-assisted soft tissue mobilization application 2 sessions per week together with 3 sessions of classical physiotherapy per week for 4 weeks. IASTM application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region).
Foam Roller Technique ApplicationOther
2 sessions of foam roller technique per week along with 3 sessions of classical physiotherapy per week for 4 weeks. Foam roller application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | An average of 20 people will be taken into the control group. Receives: Other: Classical Physiotherapy |
| IASTM Treatment Group | Experimental | An average of 20 people will receive IASTM application treatment. Receives: Other: IASTM Technique Application |
| Foam Roller Treatment Group | Experimental | An average of 20 people will receive Foam Roller application treatment. Receives: Other: Foam Roller Technique Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength Assessment
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Measured: Pre-treatment assessment.
Muscle Strength Assessment
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Measured: Second evaluation immediately after the end of 4 weeks of treatment.
Muscle Strength Assessment
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Measured: Control evaluation 1 month after the end of treatment (third evaluation).
Flexibility Assessment
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Measured: Pre-treatment assessment.
Flexibility Assessment
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Measured: Second evaluation immediately after the end of 4 weeks of treatment.
Flexibility Assessment
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Measured: Control evaluation 1 month after the end of treatment (third evaluation).
Pain Assessment
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Measured: Pre-treatment assessment.
Pain Assessment
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Measured: Second evaluation immediately after the end of 4 weeks of treatment.
Pain Assessment
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Measured: Control evaluation 1 month after the end of treatment (third evaluation).
Secondary outcomes (9)
Functional Status Assessment Questionnaire
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Measured: Pre-treatment assessment.
Functional Status Assessment Questionnaire
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Measured: Second evaluation immediately after the end of 4 weeks of treatment.
Functional Status Assessment Questionnaire
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Measured: Control evaluation 1 month after the end of treatment (third evaluation).
Joint Range of Motion Assessment
A goniometer will be used to evaluate the patients' range of motion.
Measured: Pre-treatment assessment.
Joint Range of Motion Assessment
A goniometer will be used to evaluate the patients' range of motion.
Measured: Second evaluation immediately after the end of 4 weeks of treatment.
Joint Range of Motion Assessment
A goniometer will be used to evaluate the patients' range of motion.
Measured: Control evaluation 1 month after the end of treatment (third evaluation).
Quality of Life Assessment Questionnaire
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Measured: Pre-treatment assessment.
Quality of Life Assessment Questionnaire
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Measured: Second evaluation immediately after the end of 4 weeks of treatment.
Quality of Life Assessment Questionnaire
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Measured: Control evaluation 1 month after the end of treatment (third evaluation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Dec 2021
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instrument-assisted Soft Tissue MobilizationStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Usame TAS, Inonu University
- Investigators
- Muhammed Üsame TAŞ, Lecturer, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503602
- Sponsor's protocol ID
- ÜSAME TAŞ-001
- Status last verified
- Sep 2024
- First submitted
- 12 Aug 2022
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application on Strength, Flexibility, Pain and Secondary Outcome Measures in Individuals With Chronic Non-Specific Neck Pain.
- ClinicalTrials.gov ID
- NCT05503602
- Acronym / sponsor ID
- ÜSAME TAŞ-001
- Conditions
- Instrument-assisted Soft Tissue Mobilization, Flexibility, Foam Roller, Strength, Chronic Non-specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 16 Aug 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.
Neck pain is in fourth place among the pathologies that result in the state of disability. Acute neck pain improves greatly within 2 months, while neck pain that persists for more than 3 months takes the form of chronic neck pain. Pain adversely affects people's activities of daily living. Treatment applications such as electrotherapy, hot and cold applications are applied for purposes such as reducing pain and muscle spasm and correcting functions. In addition to such treatment options, instrument-assisted soft tissue mobilization (IASTM) and foam roller therapy have been started to be applied in many disease groups in recent years and have attracted great attention. iASTM and Foam Roller is a technique that involves the use of tools in disorders of musculoskeletal pathology and to help heal soft tissues.
The aim of this study is to investigate the effects of foam roller technique with instrument-assisted soft tissue mobilization technique in individuals of different ages with chronic non-specific neck pain. According to the data obtained, the techniques the investigators will use, together with physiotherapy programs, contribute to the treatment of individuals with chronic non-specific neck pain and to the literature.is expected to provide.
Detailed description
In the study, Foam Roller will be applied to individuals with chronic non-specific neck pain with iASTM and the effect of these techniques will be examined. Demographic information of individuals will be recorded; individuals will be evaluated in detail in terms of muscle strength, flexibility, pain and secondary outcome measures. Individuals in terms of secondary outcome measures; functional status,joint range of motion and quality of life will be evaluated.
The work plan; pre-treatment evaluation, followed by treatment, second evaluation immediately after the end of treatment and control evaluation (third evaluation) 1 month after the end of treatment. The data collection period is planned as 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Classical PhysiotherapyAn average of 20 people will be taken into the control group. |
| IASTM Treatment Group | Experimental | Other: IASTM Technique ApplicationAn average of 20 people will receive IASTM application treatment. |
| Foam Roller Treatment Group | Experimental | Other: Foam Roller Technique ApplicationAn average of 20 people will receive Foam Roller application treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Consists of individuals between the ages of 18-60,
- Being diagnosed with chronic non-specific neck pain,
- Having a score of at least 4 on the visual analog scale (VAS) of the mean neck pain intensity,
- Having non-specific neck pain at least 5 days a week for the last 12 weeks,
- To be deemed appropriate by the physical therapy physician for early physiotherapy treatment after the diagnosis of chronic non-specific neck pain.
Key exclusion criteria (6 listed)
- Individuals with a history of cervical spine surgery, cervical trauma, central nervous system diseases, cervical radiculopathy, acute inflammation and malignancy,
- Having neck pain due to specific causes (disc protrusion, radicular syndrome, whiplash, congenital deformity of the spine, spinal canal stenosis and neoplasm),
- Individuals with inflammatory rheumatic disease, active oncological disease, affective disorder, addiction and psychosis,
- Individuals who have undergone invasive treatment of the spine in the last 4 weeks or spine surgery in the previous 12 months,
- Individuals from the chronic neck pain group who are currently receiving treatment or have a neck injury resulting in a spinal fracture,
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 |
|---|---|---|
| Classical PhysiotherapyOnly classical physiotherapy application, 5 sessions per week for 4 weeks. | Other | Control Group |
| IASTM Technique ApplicationInstrument-assisted soft tissue mobilization application 2 sessions per week together with 3 sessions of classical physiotherapy per week for 4 weeks. IASTM application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region). | Other | IASTM Treatment Group |
| Foam Roller Technique Application2 sessions of foam roller technique per week along with 3 sessions of classical physiotherapy per week for 4 weeks. Foam roller application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region). | Other | Foam Roller Treatment Group |
Primary outcome
Muscle Strength Assessment
Time frame: Pre-treatment assessment.
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Muscle Strength Assessment
Time frame: Second evaluation immediately after the end of 4 weeks of treatment.
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Muscle Strength Assessment
Time frame: Control evaluation 1 month after the end of treatment (third evaluation).
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Flexibility Assessment
Time frame: Pre-treatment assessment.
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Flexibility Assessment
Time frame: Second evaluation immediately after the end of 4 weeks of treatment.
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Flexibility Assessment
Time frame: Control evaluation 1 month after the end of treatment (third evaluation).
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Pain Assessment
Time frame: Pre-treatment assessment.
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Pain Assessment
Time frame: Second evaluation immediately after the end of 4 weeks of treatment.
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Pain Assessment
Time frame: Control evaluation 1 month after the end of treatment (third evaluation).
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
9 secondary outcomes
Functional Status Assessment Questionnaire
Time frame: Pre-treatment assessment.
Functional Status Assessment Questionnaire
Time frame: Second evaluation immediately after the end of 4 weeks of treatment.
Functional Status Assessment Questionnaire
Time frame: Control evaluation 1 month after the end of treatment (third evaluation).
Joint Range of Motion Assessment
Time frame: Pre-treatment assessment.
Joint Range of Motion Assessment
Time frame: Second evaluation immediately after the end of 4 weeks of treatment.
Joint Range of Motion Assessment
Time frame: Control evaluation 1 month after the end of treatment (third evaluation).
Quality of Life Assessment Questionnaire
Time frame: Pre-treatment assessment.
Quality of Life Assessment Questionnaire
Time frame: Second evaluation immediately after the end of 4 weeks of treatment.
Quality of Life Assessment Questionnaire
Time frame: Control evaluation 1 month after the end of treatment (third evaluation).
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 1 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Muhammed Üsame TAŞ, Lecturer principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical Physiotherapy, IASTM Technique Application and Foam Roller Technique Application in people with Instrument-assisted Soft Tissue Mobilization and Flexibility, run by Inonu 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 5 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 1 Oct 2024. 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?
Muscle Strength Assessment (time frame: Pre-treatment assessment.). The study lists 9 primary outcomes in all. 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 1 Oct 2024.