Frozen Shoulder and Glucose Following Corticosteroid Injection

NCT06494657 | Not Yet Recruiting

• 1 other identifier: RD24.001
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical study is to look at what happens to blood sugar levels in people who have a frozen shoulder, who do not have diabetes after a corticosteroid injection in people with frozen shoulder.

• The primary aim of this study will be to evaluate alterations in glucose levels for people without diabetes, following corticosteroid injection for frozen shoulder.
• The secondary aims are to observe a range of clinical, physiological, and psychosocial outcomes following corticosteroid injection for people with frozen shoulder. Participants will wear a glucose measuring device, attached to the upper arm collecting readings of glucose levels for 14 days. Participants will undergo a corticosteroid injection as part of usual care.

Conditions

Frozen Shoulder; Adhesive Capsulitis

Keywords

Corticosteroid; Injection; Hyperglycemia

Outcome Measures

Primary Outcomes (2)

• Mean glucose levels

  The primary biochemical outcome is mean glucose (mmol/dL) levels pre and post injection.

  3 weeks

• Shoulder Pain and Disability Index

  The primary clinical outcome is the functional questionnaire 'Shoulder Pain and Disability Index' before and after the injection. The SPADI is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items), with the total score often described as a percentage, resulting from the summation of each component. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.

  3 weeks

Secondary Outcomes (4)

• Quick Disabilities of the Arm, Shoulder, and Hand

  3 weeks

• Pain Self Efficacy Questionnaire

  3 weeks

• Pittsburgh Sleep Quality Index

  3 weeks

• Time in glucose range %

  3 weeks

Interventions

Corticosteroid injection OTHER

Corticosteroid injection for frozen shoulder

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with a Barnet borough GP and with a diagnosis of frozen shoulder

You may qualify if:

• Aged between 45 and 65
• Without diabetes or pre-diabetes
• Glenohumeral external rotation range is equally limited actively and passively by at least 50% compared to the contralateral side.
• Other glenohumeral movements are equally limited actively and passively compared to the contralateral side in one or more additional planes of movement (such as hand behind the back/shoulder flexion/abduction/scaption).
• The symptoms have been present for at least one month.
• No significant abnormality on plain radiographs.
• Ability to provide informed consent

You may not qualify if:

• Aged 44 and under and 66 and over
• People with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g., recent breast cancer surgery or radiotherapy)
• People with prediabetes, type 1 and 2 diabetes
• A neurological disease affecting the shoulder
• Evidence of other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out by British Elbow and Shoulder Society (Rangan, 2015).
• Primary osteoarthritis of the glenohumeral joint on plain radiograph
• Calcific tendinitis
• Who have received corticosteroid injection for shoulder pain in the last 12 weeks
• On long term steroids or a recent short course of oral steroids
• Currently being treated with coumarin anticoagulants, such as warfarin
• Who have participated in another research study involving an investigational medicinal product in the past 12 weeks
• Significant renal or hepatic impairment
• Any other significant disease which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
• Systemically unwell or with infection
• Pregnant or breastfeeding

Sponsors & Collaborators

• Central London Community Healthcare NHS Trust: lead
• University of Hertfordshire: collaborator

Related Publications (12)

• Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum. 2004 Aug 15;51(4):642-51. doi: 10.1002/art.20535.

  PMID: 15334439 BACKGROUND

• Wong CK, Levine WN, Deo K, Kesting RS, Mercer EA, Schram GA, Strang BL. Natural history of frozen shoulder: fact or fiction? A systematic review. Physiotherapy. 2017 Mar;103(1):40-47. doi: 10.1016/j.physio.2016.05.009. Epub 2016 Jun 21.

  PMID: 27641499 BACKGROUND

• Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

  PMID: 29253607 BACKGROUND

• Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT Group. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ. 2015 May 14;350:h1738. doi: 10.1136/bmj.h1738. No abstract available.

  PMID: 25976398 BACKGROUND

• Shamseer L, Sampson M, Bukutu C, Schmid CH, Nikles J, Tate R, Johnston BC, Zucker D, Shadish WR, Kravitz R, Guyatt G, Altman DG, Moher D, Vohra S; CENT group. CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration. J Clin Epidemiol. 2016 Aug;76:18-46. doi: 10.1016/j.jclinepi.2015.05.018. Epub 2015 Aug 10.

  PMID: 26272791 BACKGROUND

• Lobo MA, Moeyaert M, Baraldi Cunha A, Babik I. Single-Case Design, Analysis, and Quality Assessment for Intervention Research. J Neurol Phys Ther. 2017 Jul;41(3):187-197. doi: 10.1097/NPT.0000000000000187.

  PMID: 28628553 BACKGROUND

• Punja S, Bukutu C, Shamseer L, Sampson M, Hartling L, Urichuk L, Vohra S. N-of-1 trials are a tapestry of heterogeneity. J Clin Epidemiol. 2016 Aug;76:47-56. doi: 10.1016/j.jclinepi.2016.03.023. Epub 2016 Apr 11.

  PMID: 27079847 BACKGROUND

• de la Serna D, Navarro-Ledesma S, Alayon F, Lopez E, Pruimboom L. A Comprehensive View of Frozen Shoulder: A Mystery Syndrome. Front Med (Lausanne). 2021 May 11;8:663703. doi: 10.3389/fmed.2021.663703. eCollection 2021.

  PMID: 34046418 BACKGROUND

• Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.

  PMID: 32669277 BACKGROUND

• Dyer BP, Rathod-Mistry T, Burton C, van der Windt D, Bucknall M. Diabetes as a risk factor for the onset of frozen shoulder: a systematic review and meta-analysis. BMJ Open. 2023 Jan 4;13(1):e062377. doi: 10.1136/bmjopen-2022-062377.

  PMID: 36599641 BACKGROUND

• Kooistra B, Dijkman B, Einhorn TA, Bhandari M. How to design a good case series. J Bone Joint Surg Am. 2009 May;91 Suppl 3:21-6. doi: 10.2106/JBJS.H.01573.

  PMID: 19411496 BACKGROUND

• Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, Akbar M, Moore L, Ronquillo JC, Murrell GAC, Rodeo SA. Frozen shoulder. Nat Rev Dis Primers. 2022 Sep 8;8(1):59. doi: 10.1038/s41572-022-00386-2.

  PMID: 36075904 BACKGROUND

MeSH Terms

Conditions

Bursitis; Hyperglycemia

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Simon Lewis

  Central London Community Healthcare NHS Trustr

  STUDY CHAIR

Central Study Contacts

Christine Bilsborough Smith, MSc

CONTACT

07967631668; christinebilsborough@nhs.net

Mindy Cairns, PhD

CONTACT

m.cairns@herts.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: August 16, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 30, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share