Myofascial PainNCT05297656
The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome
A study testing Instrument Assisted Soft Tissue Mobilization and Home exercises programe in people with Myofascial Pain and Instrument Assisted Soft Tissue Mobilization, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The primer aim of this study is to demonstrate the effecti of instrument assisted soft tissue mobilization on pain, functionality, quality of life and depression in the treatment of female patients with myofascial pain syndrome due to active trigger points in the upper trapezius muscles Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Myofascial Pain, Instrument Assisted Soft Tissue Mobilization
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and Home exercises programe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2022to 15 Oct 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being woman and between the ages of 18-45
- Not to be in menopause
- Pain in the upper trapezius area
- Detection of a taut band in the upper trapezius region on examination
- At least one active trigger point in the tension band in the upper trapezius region on examination
- The pain caused by the compression of the trigger point is the pain that the patient complains about
- Painful restriction of cervical lateral flexion motion during stretching
- Pain 4 or more according to NRS
Who cannot join
- 1. major surgery or trauma to the musculoskeletal system, especially the spine and upper extremities 2.History of any operation related to the head and neck region 3. Neuromuscular disease 4. History of rheumatic disease, malgnite in the active period 4. Cervical discopathy, cervical spondylosis, pathologies related to the shoulder joint and surrounding soft tissues, scoliosis, kyphosis, leg length difference, polio sequelae, developmental hip dysplasia 5. Psychiatric disease (Beck Depression Inventory score of 30 and above) 6.Obese (BMI≥30 kg/m2)
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University Faculty of Medicine
Kırşehir, City Center, 40100
About this study
Official title: The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome Due to Active Trigger Points in the Upper Trapezius Muscles
The primer aim of this study is to demonstrate the effecti of instrument assisted soft tissue mobilization on pain, functionality, quality of life and depression in the treatment of female patients with myofascial pain syndrome due to active trigger points in the upper trapezius muscles
Read the detailed description
Myofascial Pain Syndrome (MAS); It is a non-articular, non-inflammatory regional musculoskeletal pain syndrome characterized by myofascial trigger points located at muscle, fascia or tendon insertion sites and the spread of pain to reference areas by palpation of these points.
h The effectiveness of massage therapy in MAS is known. In this study, investigators will apply instrument assisted deep tissue mobilization (graston massage). Instrument-assisted soft tissue mobilization massage, which is a type of massage, will be applied by a physiotherapist who has a certificate on this subject and takes part as an assistant researcher in our study.
Soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises already prescribed for patients with musculoskeletal injuries.
The various sizes and beveled edges of the stainless steel instruments allow physiotherapists to tailor treatment to different muscle structures facing myofascial constraints.
Localized increases in blood flow and soft tissue realignment lead to muscle function, increased normal joint motion, and decreased pain.
It has been investigated in the literature for many different diseases (trigger finger, nonspecific low back pain, myofascial pain syndrome) and found to be effective.CF
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Sham Instrument Assisted Soft Tissue Mobilization, Home exercises programe
- Keywords
- miyofascial pain, Instrument Assisted Soft Tissue Mobilization, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
Instrument Assisted Soft Tissue Mobilization with graston tecnique and Home exercises programe
Sham Instrument Assisted Soft Tissue MobilizationOther
Instrument Assisted Soft Tissue Mobilization to be applied superficially so it is not like a real graston tecnique and Home exercises programe
Home exercises programeOther
Only Home exercises programe
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | A total of 8 sessions of graston massage protocol will be applied to the patients in the experimental group for 4 weeks, 2 days a week for 5 minutes, at the hospital operating within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center.
All patients will also receive home exercise therapy including stretching of the trapezius muscle and posture exercises Receives: Other: Instrument Assisted Soft Tissue Mobilization; Other: Home exercises programe |
| Sham Comparator Group | Sham comparator | A total of 8 sessions of sham graston massage protocol will be applied to the patients in the experimental group for 4 weeks, 2 days a week for 5 minutes, at the hospital operating within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center.
Sham graston massage is not a deep tissue massage, but will be performed with the device superficially, without applying pressure and mobilization.
All patients will also receive home exercises. Receives: Other: Sham Instrument Assisted Soft Tissue Mobilization; Other: Home exercises programe |
| Control group | Other | The volunteers in the control group will be only given home exercise therapy including stretching of the trapezius muscle and posture exercises Receives: Other: Home exercises programe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Algometer
The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data
Measured: Baseline
Pain Algometer
The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data
Measured: Fourth week (Posttreatment)
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) for pain assessment. In this scale, which evaluates pain with a 10-point Likert scale, 0 is scored as no pain, 5 as moderate pain, and 10 as excruciating pain.
Measured: Baseline
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) for pain assessment. In this scale, which evaluates pain with a 10-point Likert scale, 0 is scored as no pain, 5 as moderate pain, and 10 as excruciating pain.
Measured: Fourth week (Posttreatment)
Number and location of trigger points
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.
Measured: Baseline
Number and location of trigger points
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.
Measured: Fourth week (Posttreatment)
Secondary outcomes (6)
Beck depression questionnaire
Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).
Measured: Baseline
Beck depression questionnaire
Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).
Measured: Fourth week (Posttreatment)
The World Health Organization health-related quality of life-brief form
The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)
Measured: Baseline
The World Health Organization health-related quality of life-brief form
The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)
Measured: Fourth week (Posttreatment)
The neck disability index
The neck disability index is a questionnaire consisting of 10 questions with Turkish validity and reliability, which recognizes the functional evaluation of neck pain (3). Each question is scored between 0 and 5. High scores are associated with increased disability.
Measured: Baseline
The neck disability index
The neck disability index is a questionnaire consisting of 10 questions with Turkish validity and reliability, which recognizes the functional evaluation of neck pain (3). Each question is scored between 0 and 5. High scores are associated with increased disability.
Measured: Fourth week (Posttreatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start8 Apr 2022
- Primary completion15 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Cigdem Karacay, Asst Prof, Study director, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297656
- Sponsor's protocol ID
- E-77504701-604.02.-00000386201
- Other IDs
- Local ethics
- Status last verified
- Dec 2023
- First submitted
- 17 Mar 2022
- Last updated
- 26 Dec 2023
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome Due to Active Trigger Points in the Upper Trapezius Muscles
- ClinicalTrials.gov ID
- NCT05297656
- Acronym / sponsor ID
- E-77504701-604.02.-00000386201
- Keywords
- miyofascial pain, Instrument Assisted Soft Tissue Mobilization, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 28 Mar 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.
The primer aim of this study is to demonstrate the effecti of instrument assisted soft tissue mobilization on pain, functionality, quality of life and depression in the treatment of female patients with myofascial pain syndrome due to active trigger points in the upper trapezius muscles
Detailed description
Myofascial Pain Syndrome (MAS); It is a non-articular, non-inflammatory regional musculoskeletal pain syndrome characterized by myofascial trigger points located at muscle, fascia or tendon insertion sites and the spread of pain to reference areas by palpation of these points.
h The effectiveness of massage therapy in MAS is known. In this study, investigators will apply instrument assisted deep tissue mobilization (graston massage). Instrument-assisted soft tissue mobilization massage, which is a type of massage, will be applied by a physiotherapist who has a certificate on this subject and takes part as an assistant researcher in our study.
Soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises already prescribed for patients with musculoskeletal injuries.
The various sizes and beveled edges of the stainless steel instruments allow physiotherapists to tailor treatment to different muscle structures facing myofascial constraints.
Localized increases in blood flow and soft tissue realignment lead to muscle function, increased normal joint motion, and decreased pain.
It has been investigated in the literature for many different diseases (trigger finger, nonspecific low back pain, myofascial pain syndrome) and found to be effective.CF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Instrument Assisted Soft Tissue Mobilization, Other: Home exercises programeA total of 8 sessions of graston massage protocol will be applied to the patients in the experimental group for 4 weeks, 2 days a week for 5 minutes, at the hospital operating within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. All patients will also receive home exercise therapy including stretching of the trapezius muscle and posture exercises |
| Sham Comparator Group | Sham comparator | Other: Sham Instrument Assisted Soft Tissue Mobilization, Other: Home exercises programeA total of 8 sessions of sham graston massage protocol will be applied to the patients in the experimental group for 4 weeks, 2 days a week for 5 minutes, at the hospital operating within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Sham graston massage is not a deep tissue massage, but will be performed with the device superficially, without applying pressure and mobilization. All patients will also receive home exercises. |
| Control group | Other | Other: Home exercises programeThe volunteers in the control group will be only given home exercise therapy including stretching of the trapezius muscle and posture exercises |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Being woman and between the ages of 18-45
- Not to be in menopause
- Pain in the upper trapezius area
- Detection of a taut band in the upper trapezius region on examination
- At least one active trigger point in the tension band in the upper trapezius region on examination
Key exclusion criteria (2 listed)
- 1. major surgery or trauma to the musculoskeletal system, especially the spine and upper extremities 2.History of any operation related to the head and neck region 3. Neuromuscular disease 4. History of rheumatic disease, malgnite in the active period 4. Cervical discopathy, cervical spondylosis, pathologies related to the shoulder joint and surrounding soft tissues, scoliosis, kyphosis, leg length difference, polio sequelae, developmental hip dysplasia 5. Psychiatric disease (Beck Depression Inventory score of 30 and above) 6.Obese (BMI≥30 kg/m2)
- -
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 MobilizationInstrument Assisted Soft Tissue Mobilization with graston tecnique and Home exercises programe | Other | Experimental Group |
| Sham Instrument Assisted Soft Tissue MobilizationInstrument Assisted Soft Tissue Mobilization to be applied superficially so it is not like a real graston tecnique and Home exercises programe | Other | Sham Comparator Group |
| Home exercises programeOnly Home exercises programe | Other | Control group, Experimental Group, Sham Comparator Group |
Primary outcome
Pain Algometer
Time frame: Baseline
The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data
Pain Algometer
Time frame: Fourth week (Posttreatment)
The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data
Visual Analogue Scale (VAS)
Time frame: Baseline
Visual Analogue Scale (VAS) for pain assessment. In this scale, which evaluates pain with a 10-point Likert scale, 0 is scored as no pain, 5 as moderate pain, and 10 as excruciating pain.
Visual Analogue Scale (VAS)
Time frame: Fourth week (Posttreatment)
Visual Analogue Scale (VAS) for pain assessment. In this scale, which evaluates pain with a 10-point Likert scale, 0 is scored as no pain, 5 as moderate pain, and 10 as excruciating pain.
Number and location of trigger points
Time frame: Baseline
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.
Number and location of trigger points
Time frame: Fourth week (Posttreatment)
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.
6 secondary outcomes
Beck depression questionnaire
Time frame: Baseline
Beck depression questionnaire
Time frame: Fourth week (Posttreatment)
The World Health Organization health-related quality of life-brief form
Time frame: Baseline
The World Health Organization health-related quality of life-brief form
Time frame: Fourth week (Posttreatment)
The neck disability index
Time frame: Baseline
The neck disability index
Time frame: Fourth week (Posttreatment)
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 26 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Myofascial Pain
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
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
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
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.
Basak Cigdem Karacay, Asst Prof study director
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 Instrument Assisted Soft Tissue Mobilization and Home exercises programe in people with Myofascial Pain and Instrument Assisted Soft Tissue Mobilization, run by Kirsehir Ahi Evran Universitesi 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 8 inclusion and 2 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 26 Dec 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 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?
Pain Algometer (time frame: Baseline). The study lists 6 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 26 Dec 2023.