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

October 25, 2010
July 26, 2012
October 2010
May 2012   (final data collection date for primary outcome measure)
  • 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.
  • 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, 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, 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, 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.
Complete list of historical versions of study NCT01232218 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Treatment Protocol for Hemiplegic Shoulder Pain
Effectiveness of a Three-Dimensional Scapular-Humeral Mobilization Technique on Hemiplegic Shoulder Pain

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Hemiplegia
  • Shoulder Pain
  • 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
  • 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
  • Active Comparator: Current Standard Treatment
    Current standard treatment for hemiplegic shoulder pain will be provided to this group.
    Intervention: Other: Standard education/exercises for hemiplegic shoulder pain
  • 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.
    Intervention: Other: Three dimensional Scapular-Humeral Mobilizations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2012
May 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01232218
DRLP-10-010
No
Denyse Richardson, Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
  • University of Toronto
  • Connect Learning Centre
  • Ontario Stroke Network
Principal Investigator: Denyse Richardson, MD; M.Ed Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP