search
Back to results

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

Primary Purpose

Central Sensitisation, Subacromial Impingement Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Injection of 1 CC Betamethasone Dipropionate + Betamethasone Sodium Phosphate (Diprospan) and 4 cc 2% Prilocaine (Priloc)mixture into the subacromial space
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Central Sensitisation focused on measuring central sensitisation, central sensitization inventory, subacromial impingement, shoulder pain, steroid injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sultan Abdülhamid Han Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with subacromial impingement syndrome (central sensitization positive)

Patients with subacromial impingement syndrome (central sensitization negative)

Arm Description

Subacromial steroid injection While the patient is in a sitting position the subacromial space and the rotator cuff will be evaluated with the sonosite-m turbo ultrasonography device linear probe. The area where the rotator cuff and subacromial bursa are most prominent will be determined under the deltoid muscle. The injection site is first covered with povidone iodine and then with 80% alcohol solution will be wiped to provide antisepsis. The subacromial bursa between the deltoid muscle and the rotator cuff will be advanced from lateral to medial with an inplane approach with a 21 g 38 mm needle under the guidance of ultrasonography. Bleeding after making sure that the needle tip is in the bursa by checking, 1 cc betamethasone dipropionate + betamethasone sodium phosphate and 4 cc 2% prilocaine mixture will be injected, showing that it is evenly distributed in the bursa.

Subacromial steroid injection While the patient is in a sitting position the subacromial space and the rotator cuff will be evaluated with the sonosite-m turbo ultrasonography device linear probe. The area where the rotator cuff and subacromial bursa are most prominent will be determined under the deltoid muscle. The injection site is first covered with povidone iodine and then with 80% alcohol solution will be wiped to provide antisepsis. The subacromial bursa between the deltoid muscle and the rotator cuff will be advanced from lateral to medial with an inplane approach with a 21 g 38 mm needle under the guidance of ultrasonography. Bleeding after making sure that the needle tip is in the bursa by checking, 1 cc betamethasone dipropionate + betamethasone sodium phosphate and 4 cc 2% prilocaine mixture will be injected, showing that it is evenly distributed in the bursa.

Outcomes

Primary Outcome Measures

Visual analog scale
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Visual analog scale
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Visual analog scale
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Shoulder range of motion
Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex
Shoulder range of motion
Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex
Shoulder range of motion
Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex

Secondary Outcome Measures

QuickDASH
QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.
QuickDASH
QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.
QuickDASH
QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.
SF-36 (Short form-36)
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.
SF-36 (Short form-36)
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.
SF-36 (Short form-36)
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.
Hospital anxiety and depression scale (HADS)
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.
Hospital anxiety and depression scale (HADS)
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.
Hospital anxiety and depression scale (HADS)
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.
hand grip strength
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.
hand grip strength
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.
hand grip strength
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.
Pressure pain threshold (PPT)
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.
Pressure pain threshold (PPT)
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.
Pressure pain threshold (PPT)
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.

Full Information

First Posted
June 14, 2023
Last Updated
June 23, 2023
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
search

1. Study Identification

Unique Protocol Identification Number
NCT05926895
Brief Title
Investigation of the Effect of Central Sensitization (CS) on Steroid Injection Response in Rotator Cuff Lesion
Acronym
CS
Official Title
Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: Is central sensitization associated with decreased treatment response? 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Sensitisation, Subacromial Impingement Syndrome
Keywords
central sensitisation, central sensitization inventory, subacromial impingement, shoulder pain, steroid injection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be followed up in two groups according to the presence of central sensitization before treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with subacromial impingement syndrome (central sensitization positive)
Arm Type
Experimental
Arm Description
Subacromial steroid injection While the patient is in a sitting position the subacromial space and the rotator cuff will be evaluated with the sonosite-m turbo ultrasonography device linear probe. The area where the rotator cuff and subacromial bursa are most prominent will be determined under the deltoid muscle. The injection site is first covered with povidone iodine and then with 80% alcohol solution will be wiped to provide antisepsis. The subacromial bursa between the deltoid muscle and the rotator cuff will be advanced from lateral to medial with an inplane approach with a 21 g 38 mm needle under the guidance of ultrasonography. Bleeding after making sure that the needle tip is in the bursa by checking, 1 cc betamethasone dipropionate + betamethasone sodium phosphate and 4 cc 2% prilocaine mixture will be injected, showing that it is evenly distributed in the bursa.
Arm Title
Patients with subacromial impingement syndrome (central sensitization negative)
Arm Type
Experimental
Arm Description
Subacromial steroid injection While the patient is in a sitting position the subacromial space and the rotator cuff will be evaluated with the sonosite-m turbo ultrasonography device linear probe. The area where the rotator cuff and subacromial bursa are most prominent will be determined under the deltoid muscle. The injection site is first covered with povidone iodine and then with 80% alcohol solution will be wiped to provide antisepsis. The subacromial bursa between the deltoid muscle and the rotator cuff will be advanced from lateral to medial with an inplane approach with a 21 g 38 mm needle under the guidance of ultrasonography. Bleeding after making sure that the needle tip is in the bursa by checking, 1 cc betamethasone dipropionate + betamethasone sodium phosphate and 4 cc 2% prilocaine mixture will be injected, showing that it is evenly distributed in the bursa.
Intervention Type
Drug
Intervention Name(s)
Injection of 1 CC Betamethasone Dipropionate + Betamethasone Sodium Phosphate (Diprospan) and 4 cc 2% Prilocaine (Priloc)mixture into the subacromial space
Intervention Description
Treatment method used in the treatment of subacromial impingement syndrome
Primary Outcome Measure Information:
Title
Visual analog scale
Description
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Time Frame
1 week
Title
Visual analog scale
Description
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Time Frame
1 months
Title
Visual analog scale
Description
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Time Frame
3 months
Title
Shoulder range of motion
Description
Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex
Time Frame
1 weeks
Title
Shoulder range of motion
Description
Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex
Time Frame
1 months
Title
Shoulder range of motion
Description
Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex
Time Frame
3 months
Secondary Outcome Measure Information:
Title
QuickDASH
Description
QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.
Time Frame
1 weeks
Title
QuickDASH
Description
QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.
Time Frame
1 months
Title
QuickDASH
Description
QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.
Time Frame
3 months
Title
SF-36 (Short form-36)
Description
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.
Time Frame
1 week
Title
SF-36 (Short form-36)
Description
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.
Time Frame
1 months
Title
SF-36 (Short form-36)
Description
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.
Time Frame
3 months
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
1 week
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
1 month
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
3 month
Title
hand grip strength
Description
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.
Time Frame
1 week
Title
hand grip strength
Description
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.
Time Frame
1 months
Title
hand grip strength
Description
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.
Time Frame
3 months
Title
Pressure pain threshold (PPT)
Description
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.
Time Frame
1 week
Title
Pressure pain threshold (PPT)
Description
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.
Time Frame
1 months
Title
Pressure pain threshold (PPT)
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Central sensitization inventory (CSI)
Description
Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.
Time Frame
1week
Title
Central sensitization inventory (CSI)
Description
Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.
Time Frame
1 months
Title
Central sensitization inventory (CSI)
Description
Clinical scale used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feyza Nur Yücel, Specialist
Phone
+905385577059
Email
dr.fny28@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre Ata, Asst.Prof
Organizational Affiliation
Sultan Abdülhamid Han Research and Training Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sultan Abdülhamid Han Research and Training Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feyza Nur Yücel
Phone
5385577059
Ext
+90
Email
dr.fny28@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20961685
Citation
Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
Results Reference
result
PubMed Identifier
25523242
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.
Results Reference
result
PubMed Identifier
23619203
Citation
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.
Results Reference
result
PubMed Identifier
33399396
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.
Results Reference
result
PubMed Identifier
33123644
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs