Chronic Pain Clinical Trial
Official title:
Investigation of the Effect of Pre-treatment Central Sensitization Severity on Steroid Injection Results in Rotator Cuff-induced Shoulder Pain
NCT number | NCT06404125 |
Other study ID # | 23/20 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sultan 2. Abdulhamid Han Training and Research Hospital | Istanbul | Üsküdar |
Lead Sponsor | Collaborator |
---|---|
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Turkey,
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. — View Citation
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/ArchRheum — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Range of Motion of Shoulde Joint | 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. | 12 months | |
Secondary | Hand Grip 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. | 12 months | |
Secondary | Numeric Rating Scale | Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale. | 12 months | |
Secondary | Pain-Pressure Threshold Measurement With an Algometer | 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 | 12 months | |
Secondary | Quick DASH | 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. | 12 months | |
Secondary | SF-36 | 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 Pinar 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. | 12 months | |
Secondary | Hospital Anxiety and Depression Scale | 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. | 12 months |
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