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Treatment Protocol for Hemiplegic Shoulder Pain (TPHSP)

This study has been completed.
Sponsor:
Collaborators:
University of Toronto
Connect Learning Centre
Ontario Stroke Network
Information provided by (Responsible Party):
Denyse Richardson, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01232218
First received: October 25, 2010
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
Hemiplegia
Shoulder Pain
 Other: Standard education/exercises for hemiplegic shoulder pain
Other: Three dimensional Scapular-Humeral Mobilizations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Three-Dimensional Scapular-Humeral Mobilization Technique on Hemiplegic Shoulder Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Measurement of active and passive pain-free shoulder range of motion [ Time Frame: 1 week prior to intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 week after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: one month after intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 week prior to intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 week prior to intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 week after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 week after intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    A descriptive scale for quantifying hemiplegic shoulder pain


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Current Standard Treatment
Current standard treatment for hemiplegic shoulder pain will be provided to this group.
 Other: Standard education/exercises for hemiplegic shoulder pain
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.
Other Name: Current Standard Treatment
Experimental: Standard treatment + study technique
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.
 Other: Three dimensional Scapular-Humeral Mobilizations
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.
Other Names:
  • Three-Demensional Scapular-Humeral Mobilization Technique
  • 3-D Scapular-Humeral Mobilizations

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232218

Locations
Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5G 2A2
Sponsors and Collaborators
Toronto Rehabilitation Institute
University of Toronto
Connect Learning Centre
Ontario Stroke Network
Investigators
Principal Investigator: Denyse Richardson, MD; M.Ed Toronto Rehabilitation Institute
  More Information

No publications provided

Responsible Party: Denyse Richardson, Dr. Denyse Richardson, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01232218     History of Changes
Other Study ID Numbers: DRLP-10-010
Study First Received: October 25, 2010
Last Updated: July 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Toronto Rehabilitation Institute:
Cerebral Vascular Accident
Stroke
Hemiplegic
Shoulder pain
 range of motion
scapula
mobilization

Additional relevant MeSH terms:
Hemiplegia
Shoulder Pain
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthralgia
 Joint Diseases
Musculoskeletal Diseases
Pain
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013