StrokeTPHSPNCT01232218
Treatment Protocol for Hemiplegic Shoulder Pain
A study testing Standard education/exercises for hemiplegic shoulder pain and Three dimensional Scapular-Humeral Mobilizations in people with Stroke and Hemiplegia, run by Toronto Rehabilitation Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegia, Shoulder Pain
- What is being tested?
- Standard education/exercises for hemiplegic shoulder pain and Three dimensional Scapular-Humeral Mobilizations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Hemiplegia, Shoulder Pain
- Being tested
- Standard education/exercises for hemiplegic shoulder pain, Three dimensional Scapular-Humeral Mobilizations
- Keywords
- Cerebral Vascular Accident, Stroke, Hemiplegic, Shoulder pain, range of motion, scapula, mobilization
- Medical subject headings
- Stroke, Hemiplegia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard education/exercises for hemiplegic shoulder painOther
Also called Current Standard Treatment
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 MobilizationsOther
Also called Three-Demensional Scapular-Humeral Mobilization Technique, 3-D 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.
| Study group | Role | What they receive |
|---|---|---|
| Current Standard Treatment | Active comparator | Current standard treatment for hemiplegic shoulder pain will be provided to this group. Receives: 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. Receives: Other: Three dimensional Scapular-Humeral Mobilizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: one month after intervention
Secondary outcomes (6)
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.
Measured: 1 week prior to intervention
Chedoke McMaster Pain Inventory
A descriptive scale for quantifying hemiplegic shoulder pain
Measured: 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.
Measured: 1 week after intervention
Chedoke McMaster Pain Inventory
A descriptive scale for quantifying hemiplegic shoulder pain
Measured: 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.
Measured: 1 month after intervention
Chedoke McMaster Pain Inventory
A descriptive scale for quantifying hemiplegic shoulder pain
Measured: 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Connect Learning Centre, Ontario Stroke Network
- Responsible party
- Principal investigator, Denyse Richardson, Toronto Rehabilitation Institute
- Investigators
- Denyse Richardson, MD; M.Ed, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232218
- Sponsor's protocol ID
- DRLP-10-010
- Acronym
- TPHSP
- Status last verified
- Jul 2012
- First submitted
- 25 Oct 2010
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Three-Dimensional Scapular-Humeral Mobilization Technique on Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT01232218
- Acronym / sponsor ID
- TPHSP / DRLP-10-010
- Conditions
- Stroke, Hemiplegia, Shoulder Pain
- Keywords
- Cerebral Vascular Accident, Stroke, Hemiplegic, Shoulder pain, range of motion, scapula, mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- University of Toronto, Connect Learning Centre, Ontario Stroke Network
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Standard Treatment | Active comparator | Other: Standard education/exercises for hemiplegic shoulder painCurrent standard treatment for hemiplegic shoulder pain will be provided to this group. |
| Standard treatment + study technique | Experimental | Other: Three dimensional Scapular-Humeral MobilizationsParticipants will receive current standard treatment for hemiplegic shoulder pain PLUS an additional stretching/strengthening technique. Both groups will be allotted the same treatment time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard education/exercises for hemiplegic shoulder painAlso: Current Standard TreatmentEach 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 | Current Standard Treatment |
| Three dimensional Scapular-Humeral MobilizationsAlso: Three-Demensional Scapular-Humeral Mobilization Technique, 3-D Scapular-Humeral MobilizationsEach 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 | Standard treatment + study technique |
Primary outcome
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.
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.
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.
6 secondary outcomes
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Time frame: 1 week prior to intervention
Chedoke McMaster Pain Inventory
Time frame: 1 week prior to intervention
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Time frame: 1 week after intervention
Chedoke McMaster Pain Inventory
Time frame: 1 week after intervention
Visual Analogue Scale (used to report the degree of pain experienced during different levels of functional reaching)
Time frame: 1 month after intervention
Chedoke McMaster Pain Inventory
Time frame: 1 month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
- Evidence-Based Review of Stroke Rehabilitation: Module 11 - Painful Hemiplegic ShoulderLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denyse Richardson, MD; M.Ed principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard education/exercises for hemiplegic shoulder pain and Three dimensional Scapular-Humeral Mobilizations in people with Stroke and Hemiplegia, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of active and passive pain-free shoulder range of motion (time frame: 1 week prior to intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.