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

NCT05926895 | Completed

• 1 other identifier: 23-20
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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:

1. 1.Is central sensitization associated with decreased treatment response?
2. 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.

Conditions

Central Sensitisation; Subacromial Impingement Syndrome

Keywords

central sensitisation; central sensitization inventory; subacromial impingement; shoulder pain; steroid injection

Outcome Measures

Primary Outcomes (6)

• 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).

  1 week

• 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).

  1 months

• 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).

  3 months

• Shoulder range of motion

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

  1 weeks

• Shoulder range of motion

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

  1 months

• Shoulder range of motion

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

  3 months

Secondary Outcomes (15)

• QuickDASH

  1 weeks

• QuickDASH

  1 months

• QuickDASH

  3 months

• SF-36 (Short form-36)

  1 week

• SF-36 (Short form-36)

  1 months

Other Outcomes (3)

• Central sensitization inventory (CSI)

  1week

• Central sensitization inventory (CSI)

  1 months

• Central sensitization inventory (CSI)

  3 months

Study Arms (2)

Patients with subacromial impingement syndrome (central sensitization positive)

EXPERIMENTAL

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.

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

Patients with subacromial impingement syndrome (central sensitization negative)

EXPERIMENTAL

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.

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

Interventions

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

Patients with subacromial impingement syndrome (central sensitization negative); Patients with subacromial impingement syndrome (central sensitization positive)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sultan Abdülhamid Han Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 20961685 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

• 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

• 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

• 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

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Interventions

betamethasone sodium phosphate; betamethasone dipropionate, betamethasone sodium phosphate drug combination; Prilocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Emre Ata, Asst.Prof

  Sultan Abdülhamid Han Research and Training Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be followed up in two groups according to the presence of central sensitization before treatment.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 3, 2023
• Study Start: June 2, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)