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Completed

NCT Number: NCT05926895

Investigation of the Effect of Central Sensitization (CS) on Steroid Injection Response in Rotator Cuff Lesion

The goal of this clinical trial is to learn whether pretreatment central sensitization presence affect shoulder steroid injection resuls in patients with rotator cuff pathology.

The main questions it aims to answer are:

1. Is central sensitization associated with decreased treatment response? 2. Do the clinical features of patients with central sensitization differ from those of those without? Participants will be applied a shoulder injection and the treatment response will be monitored.

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Key information

Conditions

Central Sensitisation Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Impingement Syndrome Shoulder Injuries Shoulder Pain Signs and Symptoms Subacromial Impingement Syndrome Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Abdülhamid Han Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

Shoulder pain is one of the most common musculoskeletal complaints and its prevalence varies between 7-26%. One of the most common sources of pain in these patients is subacromial impingement syndrome leading to rotator cuff pathology. In patients with shoulder pain, one of the factors associated with the persistence of pain in different etiologies, especially subacromial impingement syndrome, is reported as central sensitization (CS). CS can be summarized as an increase in the response of neurons located in the central nervous system to sub-threshold stimuli. In a meta-analysis of patients with shoulder pain, a decrease in pressure pain threshold was found in 29-77% of patients, and CS in 11-24%. There is increasing data showing that CS negatively affects response to different treatments, including surgery and injections. One of the most frequently used treatments in subacromial impingement syndrome is subacromial/intra-articular shoulder injection. Although various factors have been identified in the prediction of shoulder injection results, the effect of pain sensitization on these procedures is unknown. In this study, it is planned to investigate the effect of the presence and severity of pretreatment central sensitization on the results of the shoulder injection in patients with a rotator cuff lesion or subacromial impingement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rotator cuff pathology confirmed clinically and radiologically (USG/MRI)
  • Failure to respond to medical/physical treatment
  • Agree to participate in the study

Exclusion criteria

  • Shoulder trauma and history of previous shoulder surgery
  • History of injection to the painful shoulder in the last 3 months
  • Use of centrally acting drugs (antidepressants, pregabalin, gabapentin and myorelaxant etc.)
  • History of active cancer, systemic inflammatory disease, and infection
  • Pregnancy

Treatment and study plan

Injection of 1 CC Betamethasone Dipropionate + Betamethasone Sodium Phosphate (Diprospan) and 4 cc 2% Prilocaine (Priloc)mixture into the subacromial space

Drug

Treatment method used in the treatment of subacromial impingement syndrome

Primary outcomes

  1. Visual analog scale

    Time frame: 1 week

    The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).

  2. Visual analog scale

    Time frame: 1 months

    The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).

  3. Visual analog scale

    Time frame: 3 months

    The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).

  4. Shoulder range of motion

    Time frame: 1 weeks

    Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex

  5. Shoulder range of motion

    Time frame: 1 months

    Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex

  6. Shoulder range of motion

    Time frame: 3 months

    Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex

Secondary outcomes

  1. QuickDASH

    Time frame: 1 weeks

    QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.

  2. QuickDASH

    Time frame: 1 months

    QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.

  3. QuickDASH

    Time frame: 3 months

    QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.

  4. SF-36 (Short form-36)

    Time frame: 1 week

    The 36-item Short Form Questionnaire (SF-36) is used for objective measurement of quality of life. It consists of 8 dimensions scored between 0-100, and low scores are associated with poor in quality of life.

  5. SF-36 (Short form-36)

    Time frame: 1 months

    The 36-item Short Form Questionnaire (SF-36) is used for objective measurement of quality of life. It consists of 8 dimensions scored between 0-100, and low scores are associated with poor in quality of life.

  6. SF-36 (Short form-36)

    Time frame: 3 months

    The 36-item Short Form Questionnaire (SF-36) is used for objective measurement of quality of life. It consists of 8 dimensions scored between 0-100, and low scores are associated with poor in quality of life.

  7. Hospital anxiety and depression scale (HADS)

    Time frame: 1 week

    Self-test questionnaire for anxiety and depression. The score between 0 and 21 for either anxiety or depression. A score of 8 and above is significant for the diagnosis of anxiety or depression.

  8. Hospital anxiety and depression scale (HADS)

    Time frame: 1 month

    Self-test questionnaire for anxiety and depression. The score between 0 and 21 for either anxiety or depression. A score of 8 and above is significant for the diagnosis of anxiety or depression.

  9. Hospital anxiety and depression scale (HADS)

    Time frame: 3 month

    Self-test questionnaire for anxiety and depression. The score between 0 and 21 for either anxiety or depression. A score of 8 and above is significant for the diagnosis of anxiety or depression.

  10. hand grip strength

    Time frame: 1 week

    Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer.

  11. hand grip strength

    Time frame: 1 months

    Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer.

  12. hand grip strength

    Time frame: 3 months

    Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer.

  13. Pressure pain threshold (PPT)

    Time frame: 1 week

    Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity.

  14. Pressure pain threshold (PPT)

    Time frame: 1 months

    Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity.

  15. Pressure pain threshold (PPT)

    Time frame: 3 months

    Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity.

Other outcomes

  1. Central sensitization inventory (CSI)

    Time frame: 1week

    Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.

  2. Central sensitization inventory (CSI)

    Time frame: 1 months

    Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.

  3. Central sensitization inventory (CSI)

    Time frame: 3 months

    Clinical scale used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion

Acronym: CS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
Sep 12, 2025

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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