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Completed

NCT Number: NCT06447649

Investigation of Factors Affecting Shoulder Pain in Stroke Survivors

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 1 year

    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.

  2. Modified Ashworth Scale (MAS)

    Time frame: 1 year

    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

  3. Fugl Meyer Motor Assesment Scale (FMMAS)

    Time frame: 1 year

    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,

  4. Neer Impingement Test

    Time frame: 1 year

    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%.

  5. Speed Test

    Time frame: 1 year

    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.

  6. Acromioclavicular Shear Test

    Time frame: 1 year

    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%

  7. Apprehension Test

    Time frame: 1 year

    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%

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2024
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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