Evolution of Post-Stroke Shoulder Pain With a Capsular Pattern With Physiotherapy Alone Versus Coupled With Mild Arthrographic Distension With Cortisone

NCT05845125 | Terminated Phase 4

• 2 other identifiers: 2023-17272023-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of mild hydraulic distension with intra-articular corticosteroid injection for the treatment of subacute hemiparetic shoulder pain with a capsular pattern of restricted shoulder motion.

Conditions

Shoulder Pain

Keywords

adhesive capsulitis; frozen shoulder; arthrodistension; arthrographic distension; hydrodilation; cortisone injection; physiotherapy; stroke; cerebrovascular accident; hemiparetic; hemiplegic

Outcome Measures

Primary Outcomes (2)

• Pain during activities of daily living (ADLs), measured on a visual analog scale from 0 to 10

  Change of hemiparetic shoulder pain during ADLs with physiotherapy alone, to be compared with evolution over 3 months post-injection

  Baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection

• Pain at night or at rest (whichever scores highest), measured on a visual analog scale from 0 to 10

  Change of hemiparetic shoulder pain at night or at rest with physiotherapy alone, to be compared with evolution over 3 months post-injection

  Baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection

Secondary Outcomes (4)

• Passive range of motion of shoulder (ROM) including flexion, abduction, internal and external rotation in degrees, measured with a goniometer

  Baseline, 1 week pre-injection, day of injection (immediately before and immediately after injection), 3-4 weeks post-injection, 3 months post-injection

• Level of functioning, measured by the self-care section of the Functional Independence Measure.

  Baseline, day of injection, 3-4 weeks post-injection, 3 months post-injection

• Quality of life, measured by the Medical Outcomes Study Short Form 12 applied to their shoulder pain

  Baseline, day of injection, 3-4 weeks post-injection, 3 months post-injection

• Side effects, measured via auto-reported side effects and consultation with medical file

  Day of injection, 3-4 weeks post-injection, 3 months post-injection

Study Arms (2)

Physiotherapy alone

ACTIVE COMPARATOR

Physiotherapy alone after diagnosis of hemiplegic shoulder pain with a capsular pattern. The physiotherapy will focus on stretching and range of motion of the shoulder. (This is a self-controlled study. The participants' clinical evolution with physiotherapy alone will be compared to their evolution after physiotherapy coupled with the injection.)

Other: Physiotherapy alone

Physiotherapy with mild arthrographic distension

EXPERIMENTAL

Physiotherapy continues after the participant receives a mild arthrographic distension with corticosteroid of the shoulder. (This is a self-controlled study. The participants' clinical evolution with physiotherapy alone will be compared to their evolution after physiotherapy coupled with the injection.)

Drug: Glenohumeral injection of 40mg (1cc) of Triamcinolone and 7cc of 0.5% Bupivacaine coupled with physiotherapy

Interventions

Physiotherapy alone OTHER

Physiotherapy focusing on increasing the shoulder range of motion.

Physiotherapy alone

Glenohumeral injection of 40mg (1cc) of Triamcinolone and 7cc of 0.5% Bupivacaine coupled with physiotherapy DRUG

The patient will lie supine on the radiology table. Proper skin disinfection will be done with Soluprep x 3 and sterile draping will be applied. An anterior view of the shoulder will be obtained with the fluoroscopic C-arm. Location of the injection site will be obtained with a radio-opaque stylus. Proper local anesthesia will be performed using approximately 1cc of 0.5% Bupivacaine intradermal. A 22G 3.5" spinal needle will be placed in the glenohumeral joint under fluoroscopic guidance using the anterior approach. A small amount (1cc) of iodine-based contrast agent (Omnipaque) will be injected under live fluoroscopic imaging to confirm the intra-articular position of the needle in the glenohumeral joint. In the event of a known iodine contrast allergy, no contrast agent will be used. A combination of 40mg (1cc) of Triamcinolone and 7cc of 0.5% Bupivacaine will be injected into the glenohumeral joint.

Physiotherapy with mild arthrographic distension

Eligibility Criteria

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

You may qualify if:

• All participants must be enrolled in an inpatient rehabilitation program for post-stroke patients at the Institut de réadaptation Gingras-Lindsay-de-Montréal, which is encompassed by the Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de-l'Île-de-Montréal. Participants must be 18 years old or older and apt to give consent and able to reliably express themselves (either verbally, written or other) to participate in the study. Aptitude and ability to express themselves will be clinically assessed by their attending physician. Participants with a score of 3 or less out of 5 on the memory section of the Montreal Cognitive Assessment will receive special attention to ensure that the information obtained is accurate through communication with their treatment team, their medical file or their family and caregivers.
• The shoulder pain must be significant, as defined by a pain that is bothersome to the patient (limits sleep, limits time spent in wheelchair, limits ADL functioning, discomfort impacting their rehabilitation, or associated with Complex Regional Pain Syndrome), as well as a score of 3/10 on the visual analog scale during rest, at night or during ADLs, despite adequate positioning of the arm. The pain must be present for at least 2 weeks and unresolved by physiotherapy alone. Their current symptoms of shoulder pain must have started after their most recent episode of stroke. There must also be a capsular pattern of reduced ROM of the shoulder, defined by a loss of 10 degrees or more of either external rotation, abduction or internal rotation ROM compared to the non painful shoulder.

You may not qualify if:

• Patients below the age of 18 years will be excluded. Patients with pain duration of more than 6 months will be excluded. Patients inapt to give consent to participate in the study will be excluded.

Sponsors & Collaborators

• Claire Bourgeois: lead
• Fédération des médecins résidents du Québec: collaborator
• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: collaborator

Study Sites (1)

Institut de réadaptation Gingras-Lindsay-de-Montréal

Montreal, Quebec, H3S 2J4, Canada

Location

Related Publications (18)

• Adey-Wakeling Z, Arima H, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J; SEARCH Study Collaborative. Incidence and associations of hemiplegic shoulder pain poststroke: prospective population-based study. Arch Phys Med Rehabil. 2015 Feb;96(2):241-247.e1. doi: 10.1016/j.apmr.2014.09.007. Epub 2014 Sep 28.

  PMID: 25264111 BACKGROUND

• Bender L, McKenna K. Hemiplegic shoulder pain: defining the problem and its management. Disabil Rehabil. 2001 Nov 10;23(16):698-705. doi: 10.1080/09638280110062149.

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• Boyd EA, Torrance GM. Clinical measures of shoulder subluxation: their reliability. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S24-8.

  PMID: 1468045 BACKGROUND

• Catapano M, Mittal N, Adamich J, Kumbhare D, Sangha H. Hydrodilatation With Corticosteroid for the Treatment of Adhesive Capsulitis: A Systematic Review. PM R. 2018 Jun;10(6):623-635. doi: 10.1016/j.pmrj.2017.10.013. Epub 2017 Nov 10.

  PMID: 29129609 BACKGROUND

• Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.

  PMID: 33326025 BACKGROUND

• Cho JH. Updates on the treatment of adhesive capsulitis with hydraulic distension. Yeungnam Univ J Med. 2021 Jan;38(1):19-26. doi: 10.12701/yujm.2020.00535. Epub 2020 Aug 31.

  PMID: 32862630 BACKGROUND

• Dekker JH, Wagenaar RC, Lankhorst GJ, de Jong BA. The painful hemiplegic shoulder: effects of intra-articular triamcinolone acetonide. Am J Phys Med Rehabil. 1997 Jan-Feb;76(1):43-8. doi: 10.1097/00002060-199701000-00008.

  PMID: 9036910 BACKGROUND

• Dogan A, Demirtas R, Ozgirgin N. Intraarticular hydraulic distension with steroids in the management of hemiplegic shoulder. Turkish Journal of Medical Sciences. 2013; 43(2): 304-310.

  BACKGROUND

• Hall J, Dudgeon B, Guthrie M. Validity of clinical measures of shoulder subluxation in adults with poststroke hemiplegia. Am J Occup Ther. 1995 Jun;49(6):526-33. doi: 10.5014/ajot.49.6.526.

  PMID: 7645665 BACKGROUND

• Huang YC, Liang PJ, Pong YP, Leong CP, Tseng CH. Physical findings and sonography of hemiplegic shoulder in patients after acute stroke during rehabilitation. J Rehabil Med. 2010 Jan;42(1):21-6. doi: 10.2340/16501977-0488.

  PMID: 20111840 BACKGROUND

• Lakse E, Gunduz B, Erhan B, Celik EC. The effect of local injections in hemiplegic shoulder pain: a prospective, randomized, controlled study. Am J Phys Med Rehabil. 2009 Oct;88(10):805-11; quiz 812-4, 851. doi: 10.1097/PHM.0b013e3181b71c65.

  PMID: 21119312 BACKGROUND

• Lee SY, Lee KJ, Kim W, Chung SG. Relationships Between Capsular Stiffness and Clinical Features in Adhesive Capsulitis of the Shoulder. PM R. 2015 Dec;7(12):1226-1234. doi: 10.1016/j.pmrj.2015.05.012. Epub 2015 May 21.

  PMID: 26003871 BACKGROUND

• Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.

  PMID: 17185637 BACKGROUND

• Manske RC, Prohaska D. Diagnosis and management of adhesive capsulitis. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):180-9. doi: 10.1007/s12178-008-9031-6.

  PMID: 19468904 BACKGROUND

• Rah UW, Yoon SH, Moon DJ, Kwack KS, Hong JY, Lim YC, Joen B. Subacromial corticosteroid injection on poststroke hemiplegic shoulder pain: a randomized, triple-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2012 Jun;93(6):949-56. doi: 10.1016/j.apmr.2012.02.002. Epub 2012 Apr 5.

  PMID: 22483593 BACKGROUND

• Snels IA, Beckerman H, Twisk JW, Dekker JH, Peter De Koning, Koppe PA, Lankhorst GJ, Bouter LM. Effect of triamcinolone acetonide injections on hemiplegic shoulder pain : A randomized clinical trial. Stroke. 2000 Oct;31(10):2396-401. doi: 10.1161/01.str.31.10.2396.

  PMID: 11022070 BACKGROUND

• Treister AK, Hatch MN, Cramer SC, Chang EY. Demystifying Poststroke Pain: From Etiology to Treatment. PM R. 2017 Jan;9(1):63-75. doi: 10.1016/j.pmrj.2016.05.015. Epub 2016 Jun 16.

  PMID: 27317916 BACKGROUND

• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

  PMID: 27145936 BACKGROUND

Related Links

• Hemiplegic shoulder pain and complex regional pain syndrome. Evidence-Based Review of Stroke Rehabilitation.

MeSH Terms

Conditions

Shoulder Pain; Bursitis; Stroke

Interventions

Physical Therapy Modalities; Triamcinolone

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Claire Bourgeois, BSc MD

  Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal : IRGLM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: All participants will begin with a phase of physiotherapy treatment alone, followed by a phase of physiotherapy coupled with a shoulder intra-articular corticosteroid injection with hydraulic distension.

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: May 6, 2023
• Study Start: May 21, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)