- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06248372
Attentional Focus Strategies in Exercise in Patients With Myofascial Pain Syndrome
The Investigation of the Effects of Attentional Focus Strategies on Pain, Disability, Posture, Quality of Life, and Depression in Patients With Myofascial Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif Tuğçe Çil
- Phone Number: 0554 481 10 92
- Email: elif.cil@yeditepe.edu.tr
Study Contact Backup
- Name: Yağmur Barlas
- Phone Number: 05301454416
- Email: yagmurbarlas04@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: External Focus Group (EFG)
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.
|
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.
|
|
Experimental: Internal Focused Group (IFG)
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.
|
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.
|
|
Other: Control Group (CG)
Receive exercise program that includes strengthening and stretching exercises however, this group will not focus on any attentional cues while doing exercises.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
through study completion;an average 8 months
|
|
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.
|
through study completion;an average 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
New York Posture Rating Chart (NPRC)
Time Frame: through study completion;an average 8 months
|
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.
|
through study completion;an average 8 months
|
|
Neck Disability Index (NDI)
Time Frame: through study completion;an average 8 months
|
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.
|
through study completion;an average 8 months
|
|
Beck Depression Inventory (BDI)
Time Frame: through study completion;an average 8 months
|
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.
|
through study completion;an average 8 months
|
|
SF-12 Questionnaire (SF-12)
Time Frame: through study completion;an average 8 months
|
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.
|
through study completion;an average 8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yagmur
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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