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CompletedNCT06447649Updated Jun 7, 2024

Investigation of Factors Affecting Shoulder Pain in Stroke Survivors

An observational study in Stroke, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by Pamukkale University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The aim of this study was to examine the factors affecting shoulder pain in stroke survivors and to determine how much the factors affect shoulder pain

Read the detailed description

The study included 62 stroke patients who got stage 3 or more from the Brunnstrom upper limp stage. We assessed shoulder pain using the Visual Analog Scale, evaluated muscle tone using the Modified Ashworth Scale, identified myofascial trigger points by manual palpation, and measured range of motion using a universal goniometer. We employed the Fugl-Meyer Upper Extremity Assessment to assess the functional status of the upper extremities. We also used the Neer Impingement, Apprehension, Acromioclavicular Shear, and Speed Tests to evaluate the soft tissue condition.

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Conditions studied

  • Stroke

Keywords

  • Functionality
  • Hemiplegic Shoulder Pain
  • Stroke
  • Muscle Tone
  • Rehabilitation
03

In context

Shoulder Pain

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

This study's enrollment of 1 is below the median of 82 across 130 observational studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

stroke patients treated in the Physical Therapy and Rehabilitation Unit of Pamukkale University Faculty of Medicine Hospital. We conducted patient selection through screening using the Probel system, and randomly assigned patients who met the inclusion criteria and agreed to participate in the study using a random number table.

Inclusion criteria

  • having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA)
  • having experienced a first-time stroke
  • having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage
  • not having any other neurological/orthopedic problems in addition to hemiplegia
  • not having any shoulder problems on the same side (affected side) before the stroke
  • not having any shoulder problems on the same side (affected side) before the stroke

Exclusion criteria

Exclusion Criteria:

  • having a history of shoulder injury (affected side)
  • neurological and orthopedic diseases other than stroke
  • prior stroke
  • bilateral involvement
  • non-cooperation
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • study group

    We included stroke patients aged between 20 and 85. inclusion criteria for this study; having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA), having experienced a first-time stroke, having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage, not having any other neurological/orthopedic problems in addition to hemiplegia, not having any shoulder problems on the same side (affected side) before the stroke, scoring 25 or above on the Mini Mental Test.

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale (VAS)

    Visual Analog Scale (VAS) used to asses shoulder pain of stroke survivors. The patient will be asked to indicate the point on a 10 cm line that best represents their pain, with 0 indicating no pain and 10 indicating unbearable pain. Subsequently, the distance of the point from the 0 point will be measured using a ruler to determine the intensity of the pain. Following this, the patient will be inquired about the localization and type of pain.

    Time frame: 1 year

  2. Modified Ashworth Scale (MAS)

    Modified Ashworth Scale (MAS) used to evaluated of muscle tone. A scale commonly used for spasticity assessment in clinical settings. The initial form, known as the Ashworth Scale, categorizes the resistance of the extremity to passive movement within a range of 0-4 points. Subsequently, the scale includes a value of 1+, defining it as the 6-point Modified Ashworth Scale. (9) According to MAS

    Time frame: 1 year

  3. Fugl Meyer Motor Assesment Scale (FMMAS)

    Fugl Meyer Motor Assesment Scale (FMMAS) was employed to evaluate motor recovery after a stroke, it is a disease-specific, reliable, and up-to-date scale. It includes sub-sections assessing joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score achievable from the upper extremity assessment is 66,

    Time frame: 1 year

  4. Neer Impingement Test

    Neer Impingement Test was used to identify possible subacromial impingement syndrome. The patient's shoulder is passively brought into flexion and internal rotation position. The positive examination finding is the occurrence of shoulder pain during the movement of the arm in this position. The test has a sensitivity of 68% and a specificity of 68.7%.

    Time frame: 1 year

  5. Speed Test

    Speed Test was used to identify possible biceps tendon pathologies. When shoulder flexion is performed against resistance with the elbow extended and the forearm supinated, the presence of pain in the bicipital groove indicates a positive test.

    Time frame: 1 year

  6. Acromioclavicular Shear Test

    Acromioclavicular Shear Test was used to identify acromioclavicular joint pathology. The examiner cups their hands over the shoulder with the heel of one hand on the clavicle, and the heel of the other on the spine of the scapula, and then squeeze their hands together. A positive result is abnormal movement or pain at the acromioclavicular joint. The test has a sensitivity of 100% and a specificity of 97%

    Time frame: 1 year

  7. Apprehension Test

    Apprehension Test was used to detect the presence of anterior instability. As the shoulder is passively moved into maximum external rotation in abduction, and forward pressure is applied to the posterior aspect of the humeral head. If the patient expresses concern about dislocation or reports pain in the shoulder, the test is considered positive. The test has a sensitivity of 58% and a specificity of 96%

    Time frame: 1 year

07

Study locations

1 site
  • Pamukkale University
    Denizli, 20100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06447649
Lead sponsor
Pamukkale University
Responsible party
Emre BASKAN (Associate Professor, Pamukkale University) — Principal investigator
First posted
Jun 7, 2024
Start date
Dec 1, 2019
Primary completion
Apr 28, 2021
Completion
Apr 28, 2021
Last update
Jun 7, 2024

Oversight

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

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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