A Trial Comparing Glenohumeral Joint Steroid Injection Versus Suprascapular Nerve Block in Patients With Frozen Shoulder

NCT04965376 | Unknown Phase 4

• 1 other identifier: Pending
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine if there is any difference in terms of pain relief in patients with frozen shoulder, when given a steroid injection as a suprascapular nerve block compared to a glenohumeral joint intra-articular injection. The investigators hypothesis is that there is a significant difference in terms of pain relief at 3 months, 6 months and 1 year between a steroid injection as a suprascapular nerve block compared to a glenohumeral joint intra-articular injection. Participants who attend the orthopaedic clinic and are diagnosed with unilateral frozen shoulder and who are suitable to be treated with a steroid injection will be identified. If the participant consents to having a steroid injection, he/she will then be invited to participate in the trial where they will have an injection either into the glenohumeral joint (ball and socket joint of the shoulder) or as a suprascapular nerve block (injection adjacent to a nerve over the shoulder blade) under ultrasound guidance. Participants will then be followed up at 3, 6 and 12 months after their injection and asked to complete a set of questionnaires assessing pain, function and movement. The results of the groups will then be compared to see if one treatment is superior to the other.

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score (OSS) (Scored 12-60, higher score means worse outcome)

  Patient will complete in clinic

  3 months post-injection

Secondary Outcomes (4)

• Oxford Shoulder Score (Scored 12-60, higher score means worse outcome)

  6 months and 12 months post-injection

• Pain Numeric Rating Scale (Scored 0-10, higher score means worse outcome)

  3 months, 6 months and 12 months post-injection

• Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) (Scored 0-100, higher score means worse outcome)

  3 months, 6 months and 12 months post-injection

• EuroQol-5 Dimension-5 level (EQ-5D-5L)(, First part does not have min or max values and not scored on numerical scale. EQ VAS part is scored 0-100, high score means better outcome)

  3 months, 6 months and 12 months post-injection

Study Arms (2)

Glenohumeral joint injection

ACTIVE COMPARATOR

Ultrasound guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg depo-medrone)

Procedure: Glenohumeral joint steroid injection

Suprascapular nerve block

ACTIVE COMPARATOR

Ultrasound guided steroid injection as a suprascapular nerve block at the spinoglenoid notch adjacent to the nerve as it traverses under the spinoglenoid ligament (10mls of 1% lidocaine with 40mg depo-medrone)

Procedure: Suprascapular nerve block steroid injection

Interventions

Glenohumeral joint steroid injection PROCEDURE

Ultrasound guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg depo-medrone)

Glenohumeral joint injection

Suprascapular nerve block steroid injection PROCEDURE

Ultrasound guided steroid injection as a suprascapular nerve block at the spinoglenoid notch adjacent to the nerve as it traverses under the spinoglenoid ligament (10mls of 1% lidocaine with 40mg depo-medrone)

Suprascapular nerve block

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18 years
• Patient diagnosed with unilateral frozen shoulder (Diagnosis of frozen shoulder will be based on clinical examination (restriction of passive external rotation in the affected shoulder \> 50% compared to opposite site), in the presence of normal plain radiographs (antero-posterior and axillary projections) (other than calcific tendinopathy))

You may not qualify if:

• Age less than 18 years
• Lacking capacity/unable to give valid consent for participation
• Full thickness rotator cuff tear diagnosed on either Ultrasound scan or Magnetic Resonance Imaging
• Unable to complete follow up
• Unable to speak or read English
• Allergy to corticosteroid or local anaesthetic
• Simultaneous bilateral frozen shoulder.

Sponsors & Collaborators

• Blackpool Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Blackpool Victoria Hospitals NHS Foundation Trust

Blackpool, Lancashire, FY3 8NR, United Kingdom

RECRUITING

Related Publications (1)

• Jump CM, Mati W, Maley A, Taylor R, Gratrix K, Blundell C, Lane S, Solanki N, Khan M, Choudhry M, Shetty V, Malik RA, Charalambous CP. A randomized clinical trial of glenohumeral joint steroid injection versus suprascapular nerve block in patients with frozen shoulder: a protocol for the Therapeutic Injections For Frozen Shoulder (TIFFS) study. Bone Jt Open. 2023 Mar 16;4(3):205-209. doi: 10.1302/2633-1462.43.BJO-2022-0066.R1.

  PMID: 37051821 DERIVED

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Charalambos P Charalambous

  Blackpool Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charalambos P Charalambous

CONTACT

01253 300000; mr.charalambous@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Trauma & Orthopaedic Surgeon

Model Details: Ultrasound guided steroid injection into the glenohumeral joint versus ultrasound guided suprascapular nerve block

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)