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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06248372
Other study ID # Yagmur
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 30, 2024
Est. completion date September 1, 2024

Study information

Verified date January 2024
Source Yeditepe University
Contact Yagmur Barlas
Phone 05301454416
Email yagmurbarlas04@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date September 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Exercise
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Outcome

Type Measure Description Time frame Safety issue
Primary 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). through study completion;an average 8 months
Primary 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. through study completion;an average 8 months
Secondary 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. through study completion;an average 8 months
Secondary 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. through study completion;an average 8 months
Secondary 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. through study completion;an average 8 months
Secondary 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. through study completion;an average 8 months
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