NCT06248372

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 23, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

PainPressure Pain ThresholdQuality of LifeDepressionPostureMyofascial Pain SyndromeAttentional Focus Strategies

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • New York Posture Rating Chart (NPRC)

    through study completion;an average 8 months

  • Neck Disability Index (NDI)

    through study completion;an average 8 months

  • Beck Depression Inventory (BDI)

    through study completion;an average 8 months

  • SF-12 Questionnaire (SF-12)

    through study completion;an average 8 months

Study Arms (3)

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.

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.

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.

Other: Exercise

Interventions

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.

Control Group (CG)External Focus Group (EFG)Internal Focused Group (IFG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myofascial Pain SyndromesPainDepression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree Student

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 8, 2024

Study Start

January 30, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

February 8, 2024

Record last verified: 2024-01