Investigation of the Effect of Central Sensitization Symptom Severity on Steroid Injection Results in Shoulder Pain

NCT06404125 | Completed

• 1 other identifier: 23/20
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effect of the presence and severity of pre-treatment central sensitization on the results of subacromial/ intra-articular shoulder injection in patients with rotator cuff lesion/subacromial impingement. The hypothesis of the study is that the treatment response will decrease in patients with pre-injection central sensitization. There are many studies investigating the frequency of central sensitization in various shoulder pathologies. However, the effect of this condition, which is likely to be associated with chronic pain in these patients, on treatment response is unknown. The effect on the results of shoulder injection, one of the most common procedures in physical therapy practice, will be investigated.

Conditions

Rotator Cuff Lesion; Subacromial Impingement Syndrome; Shoulder Pain; Chronic Pain

Keywords

central sensitization; chronic pain; Subacromial; Shoulder; Pressure

Outcome Measures

Primary Outcomes (1)

• Central Sensitization Scale

  The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization are questioned. In part B, the presence of diseases with a well-defined relationship with central sensitization is questioned without participating in the scoring. Patients who score 40 points or more out of a total of 100 points are considered to have central sensitization. Düzce et al. stated that the Central Sensitization Scale can be used as a valid method in the Turkish population to screen the presence of central sensitization in patients presenting with chronic pain.

  12 months

Secondary Outcomes (7)

• Range of Motion of Shoulde Joint

  12 months

• Hand Grip Test

  12 months

• Numeric Rating Scale

  12 months

• Pain-Pressure Threshold Measurement With an Algometer

  12 months

• Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)

  12 months

Study Arms (2)

Group 1 (Patients without central sensitization)

Patients with rotator cuff lesions lasting more than three months and without central sensitization will be included in group 1. (n=18)

Diagnostic Test: Range of Motion of Shoulde Joint; Diagnostic Test: Hand Grip Test; Diagnostic Test: Numeric Rating Scale; Diagnostic Test: Pain-Pressure Threshold Measurement With an Algometer; Diagnostic Test: Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH); Diagnostic Test: Short Form-36; Diagnostic Test: Central Sensitization Scale; Diagnostic Test: Hospital Anxiety and Depression Scale

Group 2 (Patients with central sensitization)

patients with rotator cuff lesions lasting more than three months and central sensitization will be included in group 2. (n=18)

Diagnostic Test: Range of Motion of Shoulde Joint; Diagnostic Test: Hand Grip Test; Diagnostic Test: Numeric Rating Scale; Diagnostic Test: Pain-Pressure Threshold Measurement With an Algometer; Diagnostic Test: Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH); Diagnostic Test: Short Form-36; Diagnostic Test: Central Sensitization Scale; Diagnostic Test: Hospital Anxiety and Depression Scale

Interventions

Range of Motion of Shoulde Joint DIAGNOSTIC_TEST

Goniometric measurements will be made for both upper extremities. Flexion, extension, abduction, adduction, internal and external rotation angles of the shoulder complex will be evaluated in the measurement.

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Hand Grip Test DIAGNOSTIC_TEST

The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer (Jamar) will be used for the test. While the patient is sitting in the chair, the elbows will be close to the body and at 90 degree flexion, the wrist will be in a neutral position. The patient will be asked to grasp the dynamometer and squeeze it as hard as she can, and the average of 3 measurements made with an interval of 10 seconds. The test will be repeated for both upper extremities separately.

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Numeric Rating Scale DIAGNOSTIC_TEST

Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Pain-Pressure Threshold Measurement With an Algometer DIAGNOSTIC_TEST

The measurement will be performed 2 times with 3 min intervals for each region and the average of these applications will be recorded. Before the test, a trial test will be applied to the patient. With the pressure algometer, pressure will be applied to the selected points until it causes pain and the test will be terminated for that region when the patient feels pain. The measurement includes bilateral shoulder region and left forearm as control region and Wagner manual pressure algometer (1 cm2 probe-10 kg/20 lb) will be used. The selected points will be: 1. Bilateral supraspinatus muscle: 1 cm cranial to the midpoint of the spina scapulae 2. Bilateral infraspinatus muscle: Medial edge of the scapula, intersection of the spina scapula and the inferior scapular angle 3. Bilateral upper trapezius muscle: MidN point of the line joining the acromion and C7 spinous process 4. Left forearm volar face center as control point

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) DIAGNOSTIC_TEST

The arm, shoulder and hand problems rapid questionnaire is a shortened version of a questionnaire designed to detect symptoms and loss of function secondary to musculoskeletal problems of the upper extremity. The questionnaire will be used to assess quality of life related to upper extremity function.

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Short Form-36 DIAGNOSTIC_TEST

The scale was developed by Ware in 1987 and consists of 36 questions in which 8 sub-parameters related to the health status of the person are questioned. These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception. The Turkish validity and reliability of the scale was performed by Pınar et al. It is one of the leading methods used in the evaluation of quality of life in our country as well as all over the world.

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Central Sensitization Scale DIAGNOSTIC_TEST

The central sensitization scale was developed primarily to detect central sensitization findings in patients with chronic pain and consists of two parts, A and B. In part A, 25 somatic and psychosocial symptoms frequently found in patients with central sensitization are questioned. In part B, the presence of diseases with a well-defined relationship with central sensitization is questioned without participating in the scoring. Patients who score 40 points or more out of a total of 100 points are considered to have central sensitization. Düzce et al. stated that the Central Sensitization Scale can be used as a valid method in the Turkish population to screen the presence of central sensitization in patients presenting with chronic pain.

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Hospital Anxiety and Depression Scale DIAGNOSTIC_TEST

This scale was developed by Zigmond and Snaith in 1983 to screen anxiety and depression in individuals with physical illness. The scale consists of fourteen questions, seven for anxiety and seven for depression, to be answered on a four-point Likert scale. The Turkish validity and reliability of the scale has been demonstrated and a score above ten for anxiety and seven for depression is considered significant.

Group 1 (Patients without central sensitization); Group 2 (Patients with central sensitization)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rotator cuff lesion patients aged between 18-65 years old, who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection visiting our physical medicine and rehabilitation outpatient clinic between March 2023 and June 2024.

You may qualify if:

• Clinically and radiographically confirmed rotator cuff pathology
• Being between the ages of 18-65
• Non-response to medical treatment
• Being literate
• To agree to participate in the study

You may not qualify if:

• History of shoulder trauma and previous shoulder surgery
• Injection in the shoulder area in the last 3 months
• History of active cancer, systemic inflammatory disease and infection
• Pregnancy
• Under 18 and over 65 years of age
• Illiteracy
• Refusal to participate in the study

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

Location

Related Publications (5)

• Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.

  PMID: 35382371 RESULT

• Walankar PP, Panhale VP, Patil MM. Psychosocial factors, disability and quality of life in chronic shoulder pain patients with central sensitization. Health Psychol Res. 2020 Oct 1;8(2):8874. doi: 10.4081/hpr.2020.8874. eCollection 2020 Oct 5.

  PMID: 33123644 RESULT

• Previtali D, Bordoni V, Filardo G, Marchettini P, Guerra E, Candrian C. High Rate of Pain Sensitization in Musculoskeletal Shoulder Diseases: A Systematic Review and Meta-analysis. Clin J Pain. 2021 Mar 1;37(3):237-248. doi: 10.1097/AJP.0000000000000914.

  PMID: 33399396 RESULT

• Coronado RA, Simon CB, Valencia C, George SZ. Experimental pain responses support peripheral and central sensitization in patients with unilateral shoulder pain. Clin J Pain. 2014 Feb;30(2):143-51. doi: 10.1097/AJP.0b013e318287a2a4.

  PMID: 23619203 RESULT

• Sanchis MN, Lluch E, Nijs J, Struyf F, Kangasperko M. The role of central sensitization in shoulder pain: A systematic literature review. Semin Arthritis Rheum. 2015 Jun;44(6):710-6. doi: 10.1016/j.semarthrit.2014.11.002. Epub 2014 Nov 13.

  PMID: 25523242 RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emre Ata, Ass. Prof.

  Sultan 2. Abdulhamid Han Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: March 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

TU (1)