Treatment Protocol for Hemiplegic Shoulder Pain

NCT01232218 | Completed

• 1 other identifier: DRLP-10-010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Hemiplegia; Shoulder Pain

Keywords

Cerebral Vascular Accident; Stroke; Hemiplegic; Shoulder pain; range of motion; scapula; mobilization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

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

  1 week prior to intervention

• Chedoke McMaster Pain Inventory

  1 week prior to intervention

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

  1 week after intervention

• Chedoke McMaster Pain Inventory

  1 week after intervention

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

  1 month after intervention

Study Arms (2)

Current Standard Treatment

ACTIVE COMPARATOR

Current standard treatment for hemiplegic shoulder pain will be provided to this group.

Other: Standard education/exercises for hemiplegic shoulder pain

Standard treatment + study technique

EXPERIMENTAL

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

Interventions

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.

Also known as: Current Standard Treatment

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.

Also known as: Three-Demensional Scapular-Humeral Mobilization Technique, 3-D Scapular-Humeral Mobilizations

Standard treatment + study technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• University of Toronto: collaborator
• Connect Learning Centre: collaborator
• Ontario Stroke Network: collaborator

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

MeSH Terms

Conditions

Stroke; Hemiplegia; Shoulder Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Denyse Richardson, MD; M.Ed

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Denyse Richardson

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

CA (1)