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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404125
• Other study ID #: 23/20
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Semiha Özgüç, MD
• Phone: 5346311029
• Email: semihaozguc[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Shoulder pain is one of the most common musculoskeletal complaints and its prevalence varies between 7-26%. Although some of the patients with shoulder pain show complete recovery, pain persists in some of them. One of the most common sources of pain in these patients is subacromial impingement syndrome (SIS) leading to rotator cuff pathology. The multifactorial nature of pain in these patients makes the treatment of SIS difficult.

Central sensitization (CS) has been reported as one of the factors associated with persistence of pain in patients with shoulder pain in different etiologies, especially in the SIS. CS can be summarized as an increase in the response of neurons located in the central nervous system to subthreshold stimuli and is the source of chronic pain in many diseases. A decrease in the pressure pain threshold was observed in the painful shoulder of 58 patients with experimental pain response in the shoulder.

In a meta-analysis of patients with shoulder pain, a decrease in pressure pain threshold was found in 29-77% of patients, while SS was found in 11-24% of patients. The authors emphasized the significant correlation of CS with poor treatment response. There is increasing evidence that CS negatively affects various pain treatment responses, including surgery. Considering the frequency of CS in patients with shoulder pain, it is likely to have a negative impact on treatment response in these patients as well. One of the most common treatments for SIS is subacromial/ intra-articular shoulder injection. Although several factors have been identified in the prediction of shoulder injection outcomes, the effect of pain sensitization on these procedures is not yet known.

This study was designed as a prospective single-center study. Patients aged 18-65 years with rotator cuff lesions lasting more than three months and presenting to our physical medicine and rehabilitation outpatient clinic will be included. Patients who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection. Injection preference will be determined according to the patient primary complaint and lesion and will be administered into the subacromial space or into the shoulder joint. There is no additional interventional procedure due to the study. Patients will be divided into 2 groups with and without central sensitization. A total of 18 patients were planned for each group. The study will be conducted between March 2023 and June 2024.

Within the scope of the study, age, gender, body mass index, marital status, education level and occupation of the participants will be recorded as demographic data. Clinical evaluation includes pain duration, treatments received, pain intensity (numeric pain scale 0-10), disease-related MRI/USG findings and the following evaluations.

All patients will be evaluated before injection, 1 week, 1 and 3 months after injection. Within the scope of evaluation, Central Sensitization Scale, Quick DASH, SF-36 and Hospital Anxiety and Depression questionnaire, pressure pain threshold, goniometric shoulder range of motion measurement, hand grip strength (with Jamar hydraulic hand dynamometer), numeric pain scale (no pain: 0- unbearable pain: 10) and pain intensity will be recorded at each visit.

Data analysis will be performed by using the Statistical Package for the Social Sciences (SPSS, version 23.0, IBM Corp., Armonk, NY, USA).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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.
• 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.
• Numeric Rating Scale
Shoulder pain, feeling of tension and heaviness on the affected arm will be evaluated separately by numerical scale.
• 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: Bilateral supraspinatus muscle: 1 cm cranial to the midpoint of the spina scapulae Bilateral infraspinatus muscle: Medial edge of the scapula, intersection of the spina scapula and the inferior scapular angle Bilateral upper trapezius muscle: MidN point of the line joining the acromion and C7 spinous process Left forearm volar face center as control point
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Sultan 2. Abdulhamid Han Training and Research Hospital	Istanbul	Üsküdar

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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

Outcome

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