Clinical trial NCT01232218: Treatment Protocol for Hemiplegic Shoulder Pain
Official title: Effectiveness of a Three-Dimensional Scapular-Humeral Mobilization Technique on Hemiplegic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Shoulder Pain
Keywords: Cerebral Vascular Accident
Stroke
Hemiplegic
Shoulder pain
range of motion
scapula
mobilization
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Connect Learning Centre
name: Ontario Stroke Network
First posted: 2010-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a specific stretching and strengthening protocol, in addition to current standard treatment, is more effective for treating post-stroke shoulder pain than current standard treatment alone.

Detailed description: Current standard treatment of post-stroke shoulder pain includes joint protection (i.e., slings and protective positioning) and stretching/strengthening exercises through a pain-free range. Although the added movement of the shoulder blade when moving the post-stroke arm has been recommended in the literature, no studies to date have been found which directly looks at the impact of providing synchronized three-dimensional scapular and humeral movement during therapy. Due to the integral relationship between the scapula and the humerus during movement, it is hypothesized that an increase in 3-dimensional shoulder blade mobility in the painful post-stroke shoulder will contribute to increased pain-free 3-dimensional arm movement. This double-blind randomized-controlled study aims to investigate the effectiveness of this 3-D approach at addressing post-stroke shoulder pain.

Eligibility criteria: Inclusion Criteria:

* diagnosis of shoulder pain secondary to altered alignment and/or neuro-muscular movement patterns post-stroke;
* medically stable and 2-24 months post onset of stroke;
* between stages of 2-5 of the Chedoke-McMaster stages of upper extremity motor recovery;
* not currently receiving any other active neuro-rehabilitation intervention to promote stroke recovery;
* cognitively able to provide informed consent, follow specific testing commands, and communicate their level of pain during assessment and treatment.

Exclusion Criteria:

* a history of shoulder pain prior to the onset of the stroke;
* shoulder pain which is secondary to any history of trauma, fractures, arthritis or joint instability of the neck, spine, ribs, or shoulder girdle before or after the stroke; possible rotator cuff tears;
* shoulder-hand syndrome; thalamic or central pain; spinal cord pathology; osteoporosis;
* any medical condition which may affect the ability to participate in an active rehabilitation exercise program (i.e., uncontrolled hypertension or angina).

Primary outcomes:
measure: Measurement of active and passive pain-free shoulder range of motion
timeFrame: 1 week prior to intervention
measure: Measurement of active and passive pain-free shoulder range of motion
timeFrame: 1 week after intervention
measure: Measurement of active and passive pain-free shoulder range of motion
timeFrame: one month after intervention
Secondary outcomes:
measure: Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
timeFrame: 1 week prior to intervention
measure: Chedoke McMaster Pain Inventory
timeFrame: 1 week prior to intervention
measure: Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
timeFrame: 1 week after intervention
measure: Chedoke McMaster Pain Inventory
timeFrame: 1 week after intervention
measure: Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
timeFrame: 1 month after intervention
measure: Chedoke McMaster Pain Inventory
timeFrame: 1 month after intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Denyse Richardson, MD; M.Ed
role: PRINCIPAL_INVESTIGATOR
References: