Shoulder PainNCT02465853
Hemiplegic Shoulder Pain and Rotator Cuff Injuries
A study testing Hyaluronic Acid, Physiological saline solution and physical therapy and occupational therapy in people with Shoulder Pain and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede rehabilitation programs and the motor recovery of affected upper extremity. HSP was associated with impaired daily life activities and prolong hospital stay after stroke. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Shoulder Pain, Stroke, Rotator Cuff Injuries
- What is being tested?
- Hyaluronic Acid, Physiological saline solution and physical therapy and occupational therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Dec 2017
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subacute stroke patients with hemiplegic shoulder pain
Who cannot join
- previous shoulder pain or injury in recent 6 months
- local infection near the injection area
- shoulder arthropathy
- systemic neuromuscular disease;
- severe cardiovascular or pulmoanry disease
- impaired cognition function leading to poor communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome in Subacute Stroke Patients With Hemiplegic Shoulder Pain and Rotator Cuff Injuries After Hyaluronic Acid Injection
Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede rehabilitation programs and the motor recovery of affected upper extremity. HSP was associated with impaired daily life activities and prolong hospital stay after stroke. Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff injuries. Previous researchers reported that HA could provide pain relief, improved motion, and increased daily activities. In this study, fifty subacute stoke patients will be enrolled. These patients will be allocated into group A and B randomly. The patients in group A received HA injection while patients in group B received normal saline injection. Patients from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All the patients will still receive rehabilitation programs of physical therapy and occupational therapy. Each patient will receive physical, sonographic examinations, and stroke Specific Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA injection on pain relief, motor function recovery, and life quality in subacute stroke patients with HSP before and after HA injection.
Read the detailed description
In this study, a two-year program is expected to receive a total cases of 50 subacute stroke patients with hemiplegic shoulder pain. The patients are randomly divided into two groups. In experimental group, the patients (25 people) will accept the shoulder hyaluronic acid injections for pain management. In control group, the patients (25 people) will receive 0.9% physiological saline injections. All participants will receive total 3 times shoulder injections at the 1st, 2nd, 3rd week. Except shoulder injections, stroke patients may receive regular rehabilitation program including physical therapy and occupational therapy. All measurements including shoulder sonography, physical examinations, and the questionnaire for life quality (SSQOL) will be conducted before the first injection, after completing shoulder injection, and 3/6 months after shoulder injection. Shoulder sonography is used to investigate shoulder soft tissue condition of hemiplegic shoulder including biceps tendon, infraspinatus tendon, supraspinatus tendon, subscapularis tendon, and subdeltoid bursa in this study. The physical examination includes all shoulder motion plane, shoulder sensory (light touch, pinprick, and position sense) and motor function (Fual Meyer scale and brunnstrom motor recovery stage), shoulder spasticity measured by modified Ashworth scale, and hemiplegic shoulder pain by visual analog scale. The investigators use Stroke Specific Quality of Life Scale to evaluate the quality of life in stroke patients with HSP. In this study, the investigators want to explore the short and long term effects of HA injection on pain relief, motor function recovery, and life quality in stroke patients with HSP.
- Conditions
- Shoulder Pain, Stroke, Rotator Cuff Injuries
- Being tested
- Hyaluronic Acid, Physiological saline solution, physical therapy and occupational therapy
- Keywords
- hemiplegic shoulder pain, quality of Life, stroke
- Medical subject headings
- Shoulder Pain, Stroke, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDrug
Also called sodium hyaluronate
Injection Hyaluronic Acid in the experimental group
Physiological saline solutionDrug
Also called saline
Injection 0.9% Physiological saline solution<1.0 ml
physical therapy and occupational therapyOther
rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Injection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy Receives: Drug: Physiological saline solution; Other: physical therapy and occupational therapy |
| Hyaluronic Acid | Experimental | injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy Receives: Drug: Hyaluronic Acid; Other: physical therapy and occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline on hemiplegic shoulder sonography
use sonographic to investigate the soft tissues surrounding the hemiplegic shoulder
Measured: 1 week , 4th week, 3 month and 6 month
Secondary outcomes (6)
shoulder range of motion
goniometer Shoulder abduction 0-180, flex 0-180, ext 0-60, internal rotation 0-90, external rotation 0-90
Measured: 1 week , 4th week, 3 month and 6 month
Quality of Life
Stroke Specific Quality of Life Scale questionnaire
Measured: 1 week , 4th week, 3 month and 6 month
shoulder sensory
light touch, pin prick, position sense
Measured: 1 week , 4th week, 3 month and 6 month
shoulder pain
visual analog scale
Measured: 1 week , 4th week, 3 month and 6 month
shoulder spasticity
modified Ashworth scale
Measured: 1 week , 4th week, 3 month and 6 month
motor function
Fual Meyer scale, brunnstrom motor recovery stage
Measured: 1 week , 4th week, 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang Yu Chi, Bachelor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465853
- Sponsor's protocol ID
- CMRPG8C0771
- Status last verified
- Aug 2016
- First submitted
- 16 Dec 2014
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no available now
Publications
Najenson T, Yacubovich E, Pikielni SS. Rotator cuff injury in shoulder joints of hemiplegic patients. Scand J Rehabil Med. 1971;3(3):131-7. No abstract available.
PubMed 5156175Griffin J, Reddin G. Shoulder pain in patients with hemiplegia. A literature review. Phys Ther. 1981 Jul;61(7):1041-5. doi: 10.1093/ptj/61.7.1041. No abstract available.
PubMed 6166017Bohannon RW, Larkin PA, Smith MB, Horton MG. Shoulder pain in hemiplegia: statistical relationship with five variables. Arch Phys Med Rehabil. 1986 Aug;67(8):514-6.
PubMed 3741075Turner-Stokes L, Jackson D. Shoulder pain after stroke: a review of the evidence base to inform the development of an integrated care pathway. Clin Rehabil. 2002 May;16(3):276-98. doi: 10.1191/0269215502cr491oa.
PubMed 12017515Snels IA, Dekker JH, van der Lee JH, Lankhorst GJ, Beckerman H, Bouter LM. Treating patients with hemiplegic shoulder pain. Am J Phys Med Rehabil. 2002 Feb;81(2):150-60. doi: 10.1097/00002060-200202000-00013.
PubMed 11807352Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.
PubMed 3942479Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. doi: 10.1177/000841740407100108.
PubMed 15015899Snels IA, Beckerman H, Twisk JW, Dekker JH, Peter De Koning, Koppe PA, Lankhorst GJ, Bouter LM. Effect of triamcinolone acetonide injections on hemiplegic shoulder pain : A randomized clinical trial. Stroke. 2000 Oct;31(10):2396-401. doi: 10.1161/01.str.31.10.2396.
PubMed 11022070Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.
PubMed 3804600Wanklyn P, Forster A, Young J. Hemiplegic shoulder pain (HSP): natural history and investigation of associated features. Disabil Rehabil. 1996 Oct;18(10):497-501. doi: 10.3109/09638289609166035.
PubMed 8902421Roy C SM, Hill L. Shoulder pain in acutely admitted hemiplegics. Clinical Rehabilitation. 1994;8:334-340
Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.
PubMed 14669184Ikai T, Tei K, Yoshida K, Miyano S, Yonemoto K. Evaluation and treatment of shoulder subluxation in hemiplegia: relationship between subluxation and pain. Am J Phys Med Rehabil. 1998 Sep-Oct;77(5):421-6. doi: 10.1097/00002060-199809000-00012.
PubMed 9798835Poulin de Courval L, Barsauskas A, Berenbaum B, Dehaut F, Dussault R, Fontaine FS, Labrecque R, Leclerc C, Giroux F. Painful shoulder in the hemiplegic and unilateral neglect. Arch Phys Med Rehabil. 1990 Aug;71(9):673-6.
PubMed 2375673Ada L, Goddard E, McCully J, Stavrinos T, Bampton J. Thirty minutes of positioning reduces the development of shoulder external rotation contracture after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2005 Feb;86(2):230-4. doi: 10.1016/j.apmr.2004.02.031.
PubMed 15706548
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome in Subacute Stroke Patients With Hemiplegic Shoulder Pain and Rotator Cuff Injuries After Hyaluronic Acid Injection
- ClinicalTrials.gov ID
- NCT02465853
- Acronym / sponsor ID
- CMRPG8C0771
- Conditions
- Shoulder Pain, Stroke, Rotator Cuff Injuries
- Keywords
- hemiplegic shoulder pain, quality of Life, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Jun 2015 (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.
Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede rehabilitation programs and the motor recovery of affected upper extremity. HSP was associated with impaired daily life activities and prolong hospital stay after stroke. Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff injuries. Previous researchers reported that HA could provide pain relief, improved motion, and increased daily activities. In this study, fifty subacute stoke patients will be enrolled. These patients will be allocated into group A and B randomly. The patients in group A received HA injection while patients in group B received normal saline injection. Patients from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All the patients will still receive rehabilitation programs of physical therapy and occupational therapy. Each patient will receive physical, sonographic examinations, and stroke Specific Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA injection on pain relief, motor function recovery, and life quality in subacute stroke patients with HSP before and after HA injection.
Detailed description
In this study, a two-year program is expected to receive a total cases of 50 subacute stroke patients with hemiplegic shoulder pain. The patients are randomly divided into two groups. In experimental group, the patients (25 people) will accept the shoulder hyaluronic acid injections for pain management. In control group, the patients (25 people) will receive 0.9% physiological saline injections. All participants will receive total 3 times shoulder injections at the 1st, 2nd, 3rd week. Except shoulder injections, stroke patients may receive regular rehabilitation program including physical therapy and occupational therapy. All measurements including shoulder sonography, physical examinations, and the questionnaire for life quality (SSQOL) will be conducted before the first injection, after completing shoulder injection, and 3/6 months after shoulder injection. Shoulder sonography is used to investigate shoulder soft tissue condition of hemiplegic shoulder including biceps tendon, infraspinatus tendon, supraspinatus tendon, subscapularis tendon, and subdeltoid bursa in this study. The physical examination includes all shoulder motion plane, shoulder sensory (light touch, pinprick, and position sense) and motor function (Fual Meyer scale and brunnstrom motor recovery stage), shoulder spasticity measured by modified Ashworth scale, and hemiplegic shoulder pain by visual analog scale. The investigators use Stroke Specific Quality of Life Scale to evaluate the quality of life in stroke patients with HSP. In this study, the investigators want to explore the short and long term effects of HA injection on pain relief, motor function recovery, and life quality in stroke patients with HSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Physiological saline solution, Other: physical therapy and occupational therapyInjection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy |
| Hyaluronic Acid | Experimental | Drug: Hyaluronic Acid, Other: physical therapy and occupational therapyinjection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The subacute stroke patients with hemiplegic shoulder pain
Key exclusion criteria (6 listed)
- previous shoulder pain or injury in recent 6 months
- local infection near the injection area
- shoulder arthropathy
- systemic neuromuscular disease;
- severe cardiovascular or pulmoanry disease
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 |
|---|---|---|
| Hyaluronic AcidAlso: sodium hyaluronateInjection Hyaluronic Acid in the experimental group | Drug | Hyaluronic Acid |
| Physiological saline solutionAlso: salineInjection 0.9% Physiological saline solution<1.0 ml | Drug | Placebo group |
| physical therapy and occupational therapyrehabilitation | Other | Hyaluronic Acid, Placebo group |
Primary outcome
the change from baseline on hemiplegic shoulder sonography
Time frame: 1 week , 4th week, 3 month and 6 month
use sonographic to investigate the soft tissues surrounding the hemiplegic shoulder
6 secondary outcomes
shoulder range of motion
Time frame: 1 week , 4th week, 3 month and 6 month
Quality of Life
Time frame: 1 week , 4th week, 3 month and 6 month
shoulder sensory
Time frame: 1 week , 4th week, 3 month and 6 month
shoulder pain
Time frame: 1 week , 4th week, 3 month and 6 month
shoulder spasticity
Time frame: 1 week , 4th week, 3 month and 6 month
motor function
Time frame: 1 week , 4th week, 3 month and 6 month
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 26 Feb 2018.
- Background: PubMed 5156175Najenson T, Yacubovich E, Pikielni SS. Rotator cuff injury in shoulder joints of hemiplegic patients. Scand J Rehabil Med. 1971;3(3):131-7. No abstract available.
- Background: PubMed 6166017Griffin J, Reddin G. Shoulder pain in patients with hemiplegia. A literature review. Phys Ther. 1981 Jul;61(7):1041-5. doi: 10.1093/ptj/61.7.1041. No abstract available.
- Background: PubMed 3741075Bohannon RW, Larkin PA, Smith MB, Horton MG. Shoulder pain in hemiplegia: statistical relationship with five variables. Arch Phys Med Rehabil. 1986 Aug;67(8):514-6.
- Background: PubMed 12017515Turner-Stokes L, Jackson D. Shoulder pain after stroke: a review of the evidence base to inform the development of an integrated care pathway. Clin Rehabil. 2002 May;16(3):276-98. doi: 10.1191/0269215502cr491oa.
- Background: PubMed 11807352Snels IA, Dekker JH, van der Lee JH, Lankhorst GJ, Beckerman H, Bouter LM. Treating patients with hemiplegic shoulder pain. Am J Phys Med Rehabil. 2002 Feb;81(2):150-60. doi: 10.1097/00002060-200202000-00013.
- Background: PubMed 3942479Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.
- Background: PubMed 15015899Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. doi: 10.1177/000841740407100108.
- Background: PubMed 11022070Snels IA, Beckerman H, Twisk JW, Dekker JH, Peter De Koning, Koppe PA, Lankhorst GJ, Bouter LM. Effect of triamcinolone acetonide injections on hemiplegic shoulder pain : A randomized clinical trial. Stroke. 2000 Oct;31(10):2396-401. doi: 10.1161/01.str.31.10.2396.
- Background: PubMed 3804600Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.
- Background: PubMed 8902421Wanklyn P, Forster A, Young J. Hemiplegic shoulder pain (HSP): natural history and investigation of associated features. Disabil Rehabil. 1996 Oct;18(10):497-501. doi: 10.3109/09638289609166035.
- BackgroundRoy C SM, Hill L. Shoulder pain in acutely admitted hemiplegics. Clinical Rehabilitation. 1994;8:334-340
- Background: PubMed 14669184Lo SF, Chen SY, Lin HC, Jim YF, Meng NH, Kao MJ. Arthrographic and clinical findings in patients with hemiplegic shoulder pain. Arch Phys Med Rehabil. 2003 Dec;84(12):1786-91. doi: 10.1016/s0003-9993(03)00408-8.
- Individual participant dataSharing planned: No. no available now
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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.
Huang Yu Chi, Bachelor principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid, Physiological saline solution and physical therapy and occupational therapy in people with Shoulder Pain and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 6 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 26 Feb 2018. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
the change from baseline on hemiplegic shoulder sonography (time frame: 1 week , 4th week, 3 month and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02465853, which also lists 32 linked publications.
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 26 Feb 2018.