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CompletedNCT05814978Updated Jul 30, 2024

Effects of Scapular Therapeutic Exercise on Essential Biomechanical and Neurophysiological Parameters in Shoulder Pain Conditions With Scapular Impairments

An interventional study of Experimental Scapular Therapeutic Exercise Group in Shoulder Pain, sponsored by Polytechnic Institute of Porto. Completed at 1 site in Portugal. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Polytechnic Institute of Porto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Shoulder pain is a prevalent and recurrent condition. After a period of shoulder pain, some adaptations could be found, as in scapular muscles and kinematics and/or in nervous system.

It seems important to assess several biomechanical and neurophysiological outcomes to better characterize shoulder pain conditions and to program an intervention plane.

Therapeutic exercise is one of the treatments used for shoulder pain, however there are still doubts and controversial findings regarding exercise focusing the scapular musculature. Thus, the present study aims to assess the effects of an intervention protocol based on scapular therapeutic exercise.

Read the detailed description

The study only started after approval of the protocol

02

Conditions studied

  • Shoulder Pain

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Keywords

  • Shoulder pain
  • Scapular muscles
  • Scapular kinematics
  • Therapeutic exercise
03

In context

Shoulder Pain

725 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 577 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Polytechnic Institute of Porto is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 to 65 years old
  • Chronic (more than 3 months), continuously or intermittently, non-specific or associated with a diagnostic (except if mentioned in the exclusion criteria) shoulder pain of, at least, moderate intensity
  • Presenting scapular alterations as scapular dyskinesis (identified at rest or during motion)

Exclusion criteria

Exclusion Criteria:

  • History of shoulder fracture, dislocation, tears, infection or neoplasm
  • Shoulder surgery
  • Cervical and/or thoracic pathologies or pain associated with active movements of these regions
  • Neurological disease
  • Body mass index out of the range 18,5-30 kg/m2 and muscular skinfold higher than 20mm
  • Inability to perform the exercises
  • Current practice of competitive/high-level exercise/sport focusing the upper limb
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Experimental Scapular Therapeutic Exercise Group

    Patients in this group will perform therapeutic exercises, recommended for subjects with shoulder pain and focusing the neuromuscular control, stretching and/or strengthening of the scapular muscles

    Other: Experimental Scapular Therapeutic Exercise Group

Interventions

  • OtherExperimental Scapular Therapeutic Exercise Group

    All subjects will perform a program of scapular therapeutic exercises including: neuromuscular control/strength - scapular therapeutic exercises that leads to, at least, moderate muscular activity levels; and stretching exercises. The intervention period will be of 8 weeks, considering in-person and/or home sessions.

06

What researchers measure

Primary outcomes

  1. Change in shoulder pain

    The intensity of pain will be measured with a self-reported 11-point scale (Numerical Rating Pain Scale), with scores ranging from 0 (no pain) to 10 (maximum pain)

    Time frame: Baseline and one week after intervention

  2. Change in shoulder function

    Shoulder functional status will be measured with a self-reported 13 items scale (SPADI), which ranges from 0 (fully functional) to 100 (maximum degree of disability).

    Time frame: Baseline and one week after intervention

  3. Change in scapular muscles activity levels

    Scapular muscles activity levels, during shoulder analytical movements and during a functional task, will be recorded superficially by a wireless electromyographic signal detector system

    Time frame: Baseline and one week after intervention

  4. Change in scapular muscles ratio

    Ratio between scapular muscles activity levels, during shoulder analytical movements and during a functional task, will be calculated considered the superficially eletromyographic data measured by a wireless electromyographic signal detector system.

    Time frame: Baseline and one week after intervention

  5. Change in kinematics

    Scapular kinematics and scapulohumeral rhythm, during shoulder analytical movements and during a functional task, will be measured by inertial sensors and described in degrees (°)

    Time frame: Baseline and one week after intervention

  6. Change in movement quality through time variables

    Movement quality will be assessed considering time to peak acceleration and task completion time, calculated according to the data recorded with inertial sensors

    Time frame: Baseline and one week after intervention

  7. Change in movement quality through trunk compensation

    Movement quality will be also assessed considering the trunk motion, calculated according to the data recorded with inertial sensors

    Time frame: Baseline and one week after intervention

  8. Change in movement quality through smoothness

    Smoothness will be calculated by jerk logarithm of data recorded with inertial sensors

    Time frame: Baseline and one week after intervention

Secondary outcomes

  1. Change in muscle stiffness

    Scapular muscles stiffness will be assessed by myotonometry (using a digital palpation device)

    Time frame: Baseline and one week after intervention

  2. Change in pressure pain threshold

    An assessment point in the shoulder area will be assessed by the application of a mechanical pressure by an algometer

    Time frame: Baseline and one week after intervention

  3. Change in pain-related fear

    Assessed with self-reported scales - Tampa Scale for Kinesiophobia, which ranges from 13 (best) to 52 (worst)

    Time frame: Baseline and one week after intervention

  4. Change in pain catastrophization

    Assessed with a self-reported scale - Pain Catastrophizing Scale, which ranges from 0 (better) to 52 (worst)

    Time frame: Baseline and one week after intervention

  5. Self-impression of change

    The patient's individual perspective about his/her condition and changes felt considering the intervention received will be assessed by a self-reported scale - Patient global impression of change scale, which range from 0 \[no change (or condition has got worse)\] to 7 (a great deal better, and a considerable improvement that has made all the difference)

    Time frame: One week after intervention

07

Study locations

1 site
  • Center for Rehabilitation Research, School of Health, Polytechnic of Porto
    Porto, 4200 - 072, Portugal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Aug 2023, 4 months.

Of 327 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 4 months is below that.

Counting every sponsor, half of 336 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2023
First posted
Apr 18, 2023
StartActual
Apr 20, 2023
Primary completionActual
Aug 31, 2023
CompletionActual
Aug 31, 2023
Last update
Jul 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05814978
Lead sponsor
Polytechnic Institute of Porto
Collaborators
School of Health of Polytechnic Institute of Porto, Center for Rehabilitation Research - Human Movement System (Re)habilitation Area, Universidade do Porto, Porto Biomechanics Laboratory, Center for Interdisciplinary Applied Research in Health, Health School of the Setubal, Polytechnic Institute
Responsible party
Ana Melo (Principal Investigator - PhD grant student, Polytechnic Institute of Porto) — Principal investigator
First posted
Apr 18, 2023
Start date
Apr 20, 2023
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Jul 30, 2024

Study contacts

Ana Melo
principal investigator · Polytechnic Institute of Porto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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