Treatment Protocol for Hemiplegic Shoulder Pain

Stroke Clinical Trial

— TPHSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232218
• Other study ID #: DRLP-10-010
• Status: Completed
• Phase: N/A
• First received: October 25, 2010
• Last updated: July 26, 2012
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Shoulder Pain
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Connect Learning Centre, Ontario Stroke Network, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Chedoke McMaster Pain Inventory	A descriptive scale for quantifying hemiplegic shoulder pain	1 week prior to intervention	No
Secondary	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	No
Secondary	Chedoke McMaster Pain Inventory	A descriptive scale for quantifying hemiplegic shoulder pain	1 week after intervention	No
Secondary	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	No
Secondary	Chedoke McMaster Pain Inventory	A descriptive scale for quantifying hemiplegic shoulder pain	1 month after intervention	No