Myofascial Pain SyndromeNCT06248372
Attentional Focus Strategies in Exercise in Patients With Myofascial Pain Syndrome
A study testing Exercise in people with Myofascial Pain Syndrome, run by Yeditepe University.
Trial summary
Attentional focus is a concept of motor learning and the usage of this concept promotes exercise-induced muscular adaptations and affects motor performances. In practice,two main verbal instructions are directing the focus of attention; external focus (EFA) and internal focus of attention (IFA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2024to 1 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic MPS in the neck and upper back region (upper and middle trapezius, levator scapulae, rhomboids, infraspinatus, and supraspinatus muscles) confirmed by a physician,
- Pain lasting more than 3 months with a pain intensity is 3 or higher according to numeric pain rating scale (NPRS⩾3).
Who cannot join
- Fibromyalgia syndrome, cervical disc pathologies, malignancy, neurologic and/or inflammatory diseases, history of neck, shoulder, upper back surgery and trauma, other medical conditions that limit participation in exercise.
- Pregnancy
- Individuals being involved in physiotherapy or exercise sessions for at least 4 weeks
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Investigation of the Effects of Attentional Focus Strategies on Pain, Disability, Posture, Quality of Life, and Depression in Patients With Myofascial Pain Syndrome
Attentional focus is a concept of motor learning and the usage of this concept promotes exercise-induced muscular adaptations and affects motor performances. In practice,two main verbal instructions are directing the focus of attention; external focus (EFA) and internal focus of attention (IFA). Several studies show the results related with different health conditions. However, there is not enough studies to investigate the effectiveness of these attentional focus strategies in exercise regimes in patients with musculoskeletal problem. Thus, the study will be the first to investigate the effectiveness of attentional focus strategies in patients with neck and upper back myofascial pain syndrome (MPS) which is the most common syndrome of musculoskeletal problems.
Read the detailed description
When investigating the literature studies, there is insufficient evidence to determine which attentional focus strategies are more effective for improving function and decreasing pain in different health conditions. In most of the studies duration of symptoms of patients was not mentioned and there are no studies that directly compare EFA and IFA and report the effects on pain or functional outcomes in musculoskeletal conditions.Additionally, one study investigated the effectiveness of attentional focus strategies used in a training program but not in a musculoskeletal problem.
Thus, the study aims to investigate the effectiveness of attentional focus strategies in patients with neck and upper back MPS in terms of pain, pressure pain threshold, quality of life, depression, disability, and posture parameters.
- Conditions
- Myofascial Pain Syndrome
- Being tested
- Exercise
- Keywords
- Pain, Pressure Pain Threshold, Quality of Life, Depression, Posture, Myofascial Pain Syndrome, Attentional Focus Strategies
- Medical subject headings
- Myofascial Pain Syndromes, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Both groups will receive the same exercise program that includes strengthening and stretching exercises except for the verbal instructions which shift attention to the internal or external environment or no attentional instructions for the control group.
| Study group | Role | What they receive |
|---|---|---|
| External Focus Group (EFG) | Experimental | Receive exercise program that includes strengthening and stretching exercises however this group will focus on environmental cues apart from body movement by using metaphors or analogies. Receives: Other: Exercise |
| Internal Focused Group (IFG) | Experimental | Receive exercise program that includes strengthening and stretching exercises however this group will follow internal cues directing attention to the body movement (i.e., joint movement) while doing exercises. Receives: Other: Exercise |
| Control Group (CG) | Other | Receive exercise program that includes strengthening and stretching exercises however, this group will not focus on any attentional cues while doing exercises. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
It is a common scale to measure the perceived level of pain intensity on a numeric scale that usually includes 11 numbers. The participant is instructed to select the number that best reflects the intensity of pain experienced, with 0 representing one extreme of pain (e.g., no pain) and 10 representing the other extreme (e.g., pain as bad as it could be).
Measured: through study completion;an average 8 months
Pressure Pain Threshold (PPT)
A digital algometer (Jtech Medical Commander Echo) will be applied to measure the pressure pain threshold of the four most painful myofascial trigger points on both sides of the upper and middle trapezius, levator scapulae, rhomboids, infraspinatus, and supraspinatus. It has a circular flat tip of 1 cm2 which will be pushed slowly to the skin over the trigger points after exploration of a taut band with a normalized speed until the subject presses a switch when the compression sensation alters to pain. This process will repeat three times with a 30-second rest in between and their average will be considered as pressure pain threshold.
Measured: through study completion;an average 8 months
Secondary outcomes (4)
New York Posture Rating Chart (NPRC)
In this rating chart, posture changes that may occur in 13 different parts of the body are monitored and scored. Accordingly, 5 points will be given if the person's posture is correct, 3 points will be given if the person's posture is moderately impaired, and 1 point will be given if the person's posture is seriously impaired. The total score obtained as a result of the test. 65 is the maximum score while the minimum score is 13.
Measured: through study completion;an average 8 months
Neck Disability Index (NDI)
It is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. Each section is scored on a 0 to 5 rating scale, in which 0 means 'no pain' and 5 means 'worst imaginable pain'. The lower score means the individual's daily living activities are affected less.
Measured: through study completion;an average 8 months
Beck Depression Inventory (BDI)
It is a 21-question inventory for measuring the severity of depression. Each question has a set of four possible responses scored between 0 to 3. A total score shows the severity of depression. 0- 9 indicates minimal depression,10-18: indicates mild depression,19-29: indicates moderate depression, and 30-63: indicates severe depression. Higher total scores indicate more severe depression the individual has.
Measured: through study completion;an average 8 months
SF-12 Questionnaire (SF-12)
It is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is generally used to measure the quality of life of individuals. SF-12 is a short form of SF-36 by taking 12 different items. There are two components which is physical and mental. A higher score indicates good health status.
Measured: through study completion;an average 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start30 Jan 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yagmur Barlas, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248372
- Sponsor's protocol ID
- Yagmur
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effects of Attentional Focus Strategies on Pain, Disability, Posture, Quality of Life, and Depression in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06248372
- Acronym / sponsor ID
- Yagmur
- Conditions
- Myofascial Pain Syndrome
- Keywords
- Pain, Pressure Pain Threshold, Quality of Life, Depression, Posture, Myofascial Pain Syndrome, Attentional Focus Strategies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 8 Feb 2024 (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.
Attentional focus is a concept of motor learning and the usage of this concept promotes exercise-induced muscular adaptations and affects motor performances. In practice,two main verbal instructions are directing the focus of attention; external focus (EFA) and internal focus of attention (IFA). Several studies show the results related with different health conditions. However, there is not enough studies to investigate the effectiveness of these attentional focus strategies in exercise regimes in patients with musculoskeletal problem. Thus, the study will be the first to investigate the effectiveness of attentional focus strategies in patients with neck and upper back myofascial pain syndrome (MPS) which is the most common syndrome of musculoskeletal problems.
Detailed description
When investigating the literature studies, there is insufficient evidence to determine which attentional focus strategies are more effective for improving function and decreasing pain in different health conditions. In most of the studies duration of symptoms of patients was not mentioned and there are no studies that directly compare EFA and IFA and report the effects on pain or functional outcomes in musculoskeletal conditions.Additionally, one study investigated the effectiveness of attentional focus strategies used in a training program but not in a musculoskeletal problem.
Thus, the study aims to investigate the effectiveness of attentional focus strategies in patients with neck and upper back MPS in terms of pain, pressure pain threshold, quality of life, depression, disability, and posture parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| External Focus Group (EFG) | Experimental | Other: ExerciseReceive exercise program that includes strengthening and stretching exercises however this group will focus on environmental cues apart from body movement by using metaphors or analogies. |
| Internal Focused Group (IFG) | Experimental | Other: ExerciseReceive exercise program that includes strengthening and stretching exercises however this group will follow internal cues directing attention to the body movement (i.e., joint movement) while doing exercises. |
| Control Group (CG) | Other | Other: ExerciseReceive exercise program that includes strengthening and stretching exercises however, this group will not focus on any attentional cues while doing exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic MPS in the neck and upper back region (upper and middle trapezius, levator scapulae, rhomboids, infraspinatus, and supraspinatus muscles) confirmed by a physician,
- Pain lasting more than 3 months with a pain intensity is 3 or higher according to numeric pain rating scale (NPRS⩾3).
Key exclusion criteria (3 listed)
- Fibromyalgia syndrome, cervical disc pathologies, malignancy, neurologic and/or inflammatory diseases, history of neck, shoulder, upper back surgery and trauma, other medical conditions that limit participation in exercise.
- Pregnancy
- Individuals being involved in physiotherapy or exercise sessions for at least 4 weeks
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 |
|---|---|---|
| ExerciseBoth groups will receive the same exercise program that includes strengthening and stretching exercises except for the verbal instructions which shift attention to the internal or external environment or no attentional instructions for the control group. | Other | Control Group (CG), External Focus Group (EFG), Internal Focused Group (IFG) |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: through study completion;an average 8 months
It is a common scale to measure the perceived level of pain intensity on a numeric scale that usually includes 11 numbers. The participant is instructed to select the number that best reflects the intensity of pain experienced, with 0 representing one extreme of pain (e.g., no pain) and 10 representing the other extreme (e.g., pain as bad as it could be).
Pressure Pain Threshold (PPT)
Time frame: through study completion;an average 8 months
A digital algometer (Jtech Medical Commander Echo) will be applied to measure the pressure pain threshold of the four most painful myofascial trigger points on both sides of the upper and middle trapezius, levator scapulae, rhomboids, infraspinatus, and supraspinatus. It has a circular flat tip of 1 cm2 which will be pushed slowly to the skin over the trigger points after exploration of a taut band with a normalized speed until the subject presses a switch when the compression sensation alters to pain. This process will repeat three times with a 30-second rest in between and their average will be considered as pressure pain threshold.
4 secondary outcomes
New York Posture Rating Chart (NPRC)
Time frame: through study completion;an average 8 months
Neck Disability Index (NDI)
Time frame: through study completion;an average 8 months
Beck Depression Inventory (BDI)
Time frame: through study completion;an average 8 months
SF-12 Questionnaire (SF-12)
Time frame: through study completion;an average 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Myofascial Pain Syndrome, run by Yeditepe University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yağmur Barlas (05301454416, yagmurbarlas04@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: through study completion;an average 8 months). The study lists 2 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 8 Feb 2024.