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Treatment Protocol for Hemiplegic Shoulder Pain (TPHSP)

Primary Purpose

Stroke, Hemiplegia, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard education/exercises for hemiplegic shoulder pain
Three dimensional Scapular-Humeral Mobilizations
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Cerebral Vascular Accident, Stroke, Hemiplegic, Shoulder pain, range of motion, scapula, mobilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Current Standard Treatment

Standard treatment + study technique

Arm Description

Current standard treatment for hemiplegic shoulder pain will be provided to this group.

Participants will receive current standard treatment for hemiplegic shoulder pain PLUS an additional stretching/strengthening technique. Both groups will be allotted the same treatment time.

Outcomes

Primary Outcome Measures

Measurement of active and passive pain-free shoulder range of motion
Using a 3-dimensional motion capture system and digitizer system, we will determine degrees of pain-free active and passive movement of the shoulder and arm for each participant. Changes in range of motion between pre and post-treatment will be calculated.
Measurement of active and passive pain-free shoulder range of motion
Using a 3-dimensional motion capture system and digitizer system, we will determine degrees of pain-free active and passive movement of the shoulder and arm for each participant. Changes in range of motion between pre and post-treatment will be calculated.
Measurement of active and passive pain-free shoulder range of motion
Using a 3-dimensional motion capture system and digitizer system, we will determine degrees of pain-free active and passive movement of the shoulder and arm for each participant. Changes in range of motion between pre and post-treatment will be calculated.

Secondary Outcome Measures

Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Participants will be asked to subjectively rate their level of pain (on a scale of 1-10) when progressively reaching to the top of the head and behind the back.
Chedoke McMaster Pain Inventory
A descriptive scale for quantifying hemiplegic shoulder pain
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Participants will be asked to subjectively rate their level of pain (on a scale of 1-10) when progressively reaching to the top of the head and behind the back.
Chedoke McMaster Pain Inventory
A descriptive scale for quantifying hemiplegic shoulder pain
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Participants will be asked to subjectively rate their level of pain (on a scale of 1-10) when progressively reaching to the top of the head and behind the back.
Chedoke McMaster Pain Inventory
A descriptive scale for quantifying hemiplegic shoulder pain

Full Information

First Posted
October 25, 2010
Last Updated
July 26, 2012
Sponsor
Toronto Rehabilitation Institute
Collaborators
University of Toronto, Connect Learning Centre, Ontario Stroke Network
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1. Study Identification

Unique Protocol Identification Number
NCT01232218
Brief Title
Treatment Protocol for Hemiplegic Shoulder Pain
Acronym
TPHSP
Official Title
Effectiveness of a Three-Dimensional Scapular-Humeral Mobilization Technique on Hemiplegic Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
University of Toronto, Connect Learning Centre, Ontario Stroke Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia, Shoulder Pain
Keywords
Cerebral Vascular Accident, Stroke, Hemiplegic, Shoulder pain, range of motion, scapula, mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Current Standard Treatment
Arm Type
Active Comparator
Arm Description
Current standard treatment for hemiplegic shoulder pain will be provided to this group.
Arm Title
Standard treatment + study technique
Arm Type
Experimental
Arm Description
Participants will receive current standard treatment for hemiplegic shoulder pain PLUS an additional stretching/strengthening technique. Both groups will be allotted the same treatment time.
Intervention Type
Other
Intervention Name(s)
Standard education/exercises for hemiplegic shoulder pain
Other Intervention Name(s)
Current Standard Treatment
Intervention Description
Each participant will receive standard education for safe positioning and movement of the painful hemiplegic shoulder. Participants will also be provided with standard stretching and strengthening exercises by and experienced Occupational Therapist who will grade the level of exercise to suit their needs. Intervention will take place 3x/week for 1 hour.
Intervention Type
Other
Intervention Name(s)
Three dimensional Scapular-Humeral Mobilizations
Other Intervention Name(s)
Three-Demensional Scapular-Humeral Mobilization Technique, 3-D Scapular-Humeral Mobilizations
Intervention Description
Each participant will receive standard education for safe positioning and movement of the painful hemiplegic shoulder. Participants will also be provided with stretching and strengthening exercises by and experienced Occupational Therapist who will grade the level of exercise to suit their needs. Intervention will take place 3x/week for 1 hour. Participants in this group will receive an additional scapular humeral mobilization while simultaneously performing the standard stretching/strengthening exercise protocol.
Primary Outcome Measure Information:
Title
Measurement of active and passive pain-free shoulder range of motion
Description
Using a 3-dimensional motion capture system and digitizer system, we will determine degrees of pain-free active and passive movement of the shoulder and arm for each participant. Changes in range of motion between pre and post-treatment will be calculated.
Time Frame
1 week prior to intervention
Title
Measurement of active and passive pain-free shoulder range of motion
Description
Using a 3-dimensional motion capture system and digitizer system, we will determine degrees of pain-free active and passive movement of the shoulder and arm for each participant. Changes in range of motion between pre and post-treatment will be calculated.
Time Frame
1 week after intervention
Title
Measurement of active and passive pain-free shoulder range of motion
Description
Using a 3-dimensional motion capture system and digitizer system, we will determine degrees of pain-free active and passive movement of the shoulder and arm for each participant. Changes in range of motion between pre and post-treatment will be calculated.
Time Frame
one month after intervention
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Description
Participants will be asked to subjectively rate their level of pain (on a scale of 1-10) when progressively reaching to the top of the head and behind the back.
Time Frame
1 week prior to intervention
Title
Chedoke McMaster Pain Inventory
Description
A descriptive scale for quantifying hemiplegic shoulder pain
Time Frame
1 week prior to intervention
Title
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Description
Participants will be asked to subjectively rate their level of pain (on a scale of 1-10) when progressively reaching to the top of the head and behind the back.
Time Frame
1 week after intervention
Title
Chedoke McMaster Pain Inventory
Description
A descriptive scale for quantifying hemiplegic shoulder pain
Time Frame
1 week after intervention
Title
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Description
Participants will be asked to subjectively rate their level of pain (on a scale of 1-10) when progressively reaching to the top of the head and behind the back.
Time Frame
1 month after intervention
Title
Chedoke McMaster Pain Inventory
Description
A descriptive scale for quantifying hemiplegic shoulder pain
Time Frame
1 month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denyse Richardson, MD; M.Ed
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada

12. IPD Sharing Statement

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Treatment Protocol for Hemiplegic Shoulder Pain

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