Treatment Protocol for Hemiplegic Shoulder Pain (TPHSP)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Shoulder Pain; Hemiplegia
• Intervention / Treatment: Other: Standard education/exercises for hemiplegic shoulder pain; Other: Three dimensional 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2A2
      • Toronto Rehabilitation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week prior to intervention
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.	1 week after intervention
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.	one month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week prior to intervention
Chedoke McMaster Pain Inventory	A descriptive scale for quantifying hemiplegic shoulder pain	1 week prior to intervention
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.	1 week after intervention
Chedoke McMaster Pain Inventory	A descriptive scale for quantifying hemiplegic shoulder pain	1 week after intervention
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.	1 month after intervention
Chedoke McMaster Pain Inventory	A descriptive scale for quantifying hemiplegic shoulder pain	1 month after intervention

Collaborators and Investigators

• Sponsor: Toronto Rehabilitation Institute
• Collaborators: University of Toronto; Ontario Stroke Network; Connect Learning Centre
• Investigators: Principal Investigator: Denyse Richardson, MD; M.Ed, Toronto Rehabilitation Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (Estimate): November 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 26, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Stroke; Shoulder pain; range of motion; mobilization; Cerebral Vascular Accident; Hemiplegic; scapula
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Paralysis; Shoulder Pain; Hemiplegia
• Other Study ID Numbers: DRLP-10-010