Skip to main content
OpenTrials
Completed

NCT Number: NCT01232218

Treatment Protocol for 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard education/exercises for hemiplegic shoulder pain

Other

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 names: Current Standard Treatment

Three dimensional Scapular-Humeral Mobilizations

Other

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

Primary outcomes

  1. Measurement of active and passive pain-free shoulder range of motion

    Time frame: 1 week prior to intervention

    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.

  2. Measurement of active and passive pain-free shoulder range of motion

    Time frame: 1 week after intervention

    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.

  3. Measurement of active and passive pain-free shoulder range of motion

    Time frame: one month after intervention

    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 outcomes

  1. Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)

    Time frame: 1 week prior to intervention

    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.

  2. Chedoke McMaster Pain Inventory

    Time frame: 1 week prior to intervention

    A descriptive scale for quantifying hemiplegic shoulder pain

  3. Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)

    Time frame: 1 week after intervention

    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.

  4. Chedoke McMaster Pain Inventory

    Time frame: 1 week after intervention

    A descriptive scale for quantifying hemiplegic shoulder pain

  5. Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)

    Time frame: 1 month after intervention

    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.

  6. Chedoke McMaster Pain Inventory

    Time frame: 1 month after intervention

    A descriptive scale for quantifying hemiplegic shoulder pain

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • Connect Learning Centre
  • Ontario Stroke Network
  • University of Toronto

Registry information

Official study title

Effectiveness of a Three-Dimensional Scapular-Humeral Mobilization Technique on Hemiplegic Shoulder Pain

Acronym: TPHSP

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2010
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.