Shoulder Pain Clinical Trial
Official title:
Clinical Evolution of Hemiparetic Shoulder Pain With a Capsular Pattern in a Subacute Stroke Population Following Physiotherapy Coupled With Cortisone Infiltration and Mild Arthrographic Distension Versus Physiotherapy Alone : A Pragmatic Study
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. Patients who have had multiple strokes will not be excluded. Non-verbal patients or those with cognitive difficulties will have the option of participating with assistance in answering questionnaires by their primary caregiver, a healthcare worker or information recorded in the medical file. Previous shoulder ailments are not a cause for exclusion from participation but their data may be analysed separately. Patients who refuse intra-articular corticosteroid injection but accept to participate in all other aspects of the study will not be excluded as their long-term evolution undergoing physiotherapy alone may be used as a separate cohort if the sample size is large enough. |
Country | Name | City | State |
---|---|---|---|
Canada | Institut de réadaptation Gingras-Lindsay-de-Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Claire Bourgeois | Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Fédération des médecins résidents du Québec |
Canada,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Passive range of motion of shoulder (ROM) including flexion, abduction, internal and external rotation in degrees, measured with a goniometer | Evolution of passive range or motion of the hemiparetic shoulder with physiotherapy alone, to be compared with evolution over 3 months post-injection. There will be two recorded values for each movement. One value represents the start of pain sensation and one value represents either the degree at which the joint end feel is present or at the maximum tolerance of pain for the participant, whichever is present first. | Baseline, 1 week pre-injection, day of injection (immediately before and immediately after injection), 3-4 weeks post-injection, 3 months post-injection | |
Secondary | Level of functioning, measured by the self-care section of the Functional Independence Measure. | Evolution of level of functioning with physiotherapy alone, to be compared with evolution over 3 months post-injection | Baseline, day of injection, 3-4 weeks post-injection, 3 months post-injection | |
Secondary | Quality of life, measured by the Medical Outcomes Study Short Form 12 applied to their shoulder pain | Evolution of quality of life with physiotherapy alone, to be compared with evolution over 3 months post-injection | Baseline, day of injection, 3-4 weeks post-injection, 3 months post-injection | |
Secondary | Side effects, measured via auto-reported side effects and consultation with medical file | Type and severity of side effects of injection. Examples of potential side effects will be provided (nausea, dizziness, pain, metrorrhagia, infection, bleeding, hematoma, high blood pressure, hyperglycemia, temporary increase of shoulder pain) although other side effects will also be noted. Participants will be asked if there was any medication prescribed or modified in order to treat these side effects. | Day of injection, 3-4 weeks post-injection, 3 months post-injection |
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