Shoulder PainNCT02541279
Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
A study testing Physiotherapy exercises guideline in people with Shoulder Pain, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
The investigators determined the effectiveness of a group intervention for the treatment of shoulder pathologies. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Physiotherapy exercises guideline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Jul 2015
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patients who came to the Rehabilitation Service of the San Juan de Alicante Hospital between November 2014 and July 2015 with one of the diagnosed diseases indicated in the 726.10 ICD-9-CM code (nontraumatic rotator cuff tear, bursitis, tendinitis, and medical diagnostics impingement syndrome of any severity depending stadiums Neer (1990) unilateral or bilateral joint balance with free or minimally limited internal rotation).
Who cannot join
- Patients who cannot perform the exercises correctly (example: psychiatry disorders)
- Patients with Shoulder surgery
- Patients whose shoulder pain is above 7 according VAS pain.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators determined the effectiveness of a group intervention for the treatment of shoulder pathologies.
Read the detailed description
The investigators performed a two-armed prospective clinical trial study, analyzing a sample formed by 76 patients with shoulder pain. The patients were allocated to one group randomly (intervention or control group). The data was obtained in the San Juan de Alicante Hospital between November 2014 and July 2015.
- Conditions
- Shoulder Pain
- Being tested
- Physiotherapy exercises guideline
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy exercises guidelineProcedure or surgery
Exercises controlled by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group received 6 sessions of shoulder exercises controlled by a physiotherapist. Receives: Procedure: Physiotherapy exercises guideline |
| Control | Active comparator | The control group received a paper explaining the same exercises which were performed by the intervention group. This group made the exercises at home. Receives: Procedure: Physiotherapy exercises guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Murley Test
This test assesses daily activities.
Measured: before/after intervention ( 6 weeks)
Secondary outcomes (3)
Quick-DASH Test
This test assesses functional limitation in upper limb musculoskeletal disorders.
Measured: before/after intervention ( 6 weeks)
Pain NRS (numeric rating scale)
Instruct the patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean 'No pain' and 10 would mean 'Worst possible pain'
Measured: before/after intervention ( 6 weeks)
Measurement of the average force
Average force: Measurement was assessed in newtons
Measured: before/after intervention ( 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Juan de Alicante
- Responsible party
- Principal investigator, María Isabel Tomás-Rodríguez, PT, Universidad Miguel Hernandez de Elche
- Investigators
- M Rosario Asensio Garcia, Phd, Principal investigator, Universidad Miguel Hernández de Elche Alicante Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541279
- Sponsor's protocol ID
- 14/324
- Status last verified
- Oct 2016
- First submitted
- 31 Jul 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Bervoets DC, Luijsterburg PA, Alessie JJ, Buijs MJ, Verhagen AP. Massage therapy has short-term benefits for people with common musculoskeletal disorders compared to no treatment: a systematic review. J Physiother. 2015 Jul;61(3):106-16. doi: 10.1016/j.jphys.2015.05.018. Epub 2015 Jun 17.
PubMed 26093806Senbursa G, Baltaci G, Atay A. Comparison of conservative treatment with and without manual physical therapy for patients with shoulder impingement syndrome: a prospective, randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):915-21. doi: 10.1007/s00167-007-0288-x. Epub 2007 Feb 28.
PubMed 17333123Bankes MJ, Emery RJ. An evaluation of the Constant-Murley shoulder assessment. J Bone Joint Surg Br. 1997 Jul;79(4):696. No abstract available.
PubMed 9250771Littlewood C, Bateman M, Brown K, Bury J, Mawson S, May S, Walters SJ. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study). Clin Rehabil. 2016 Jul;30(7):686-96. doi: 10.1177/0269215515593784. Epub 2015 Jul 9.
PubMed 26160149Page MJ, McKenzie JE, Green SE, Beaton DE, Jain NB, Lenza M, Verhagen AP, Surace S, Deitch J, Buchbinder R. Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials. J Clin Epidemiol. 2015 Nov;68(11):1270-81. doi: 10.1016/j.jclinepi.2015.06.006. Epub 2015 Jun 16.
PubMed 26092288Asensio-Garcia MDR, Bernabeu-Casas RC, Palazon-Bru A, Tomas-Rodriguez MI, Nouni-Garcia R. Effectiveness of a Group Physiotherapy Intervention in Nontraumatic, Inoperable Painful Shoulder: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2018 Feb;97(2):110-115. doi: 10.1097/PHM.0000000000000817.
PubMed 28857770
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
- ClinicalTrials.gov ID
- NCT02541279
- Acronym / sponsor ID
- 14/324
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Hospital Universitario San Juan de Alicante
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Sep 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.
The investigators determined the effectiveness of a group intervention for the treatment of shoulder pathologies.
Detailed description
The investigators performed a two-armed prospective clinical trial study, analyzing a sample formed by 76 patients with shoulder pain. The patients were allocated to one group randomly (intervention or control group). The data was obtained in the San Juan de Alicante Hospital between November 2014 and July 2015.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Physiotherapy exercises guidelineThe intervention group received 6 sessions of shoulder exercises controlled by a physiotherapist. |
| Control | Active comparator | Procedure: Physiotherapy exercises guidelineThe control group received a paper explaining the same exercises which were performed by the intervention group. This group made the exercises at home. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients who came to the Rehabilitation Service of the San Juan de Alicante Hospital between November 2014 and July 2015 with one of the diagnosed diseases indicated in the 726.10 ICD-9-CM code (nontraumatic rotator cuff tear, bursitis, tendinitis, and medical diagnostics impingement syndrome of any severity depending stadiums Neer (1990) unilateral or bilateral joint balance with free or minimally limited internal rotation).
Key exclusion criteria (3 listed)
- Patients who cannot perform the exercises correctly (example: psychiatry disorders)
- Patients with Shoulder surgery
- Patients whose shoulder pain is above 7 according VAS pain.
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 |
|---|---|---|
| Physiotherapy exercises guidelineExercises controlled by a physiotherapist. | Procedure or surgery | Control, Intervention |
Primary outcome
Constant Murley Test
Time frame: before/after intervention ( 6 weeks)
This test assesses daily activities.
3 secondary outcomes
Quick-DASH Test
Time frame: before/after intervention ( 6 weeks)
Pain NRS (numeric rating scale)
Time frame: before/after intervention ( 6 weeks)
Measurement of the average force
Time frame: before/after intervention ( 6 weeks)
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 25 Oct 2016.
- Background: PubMed 26093806Bervoets DC, Luijsterburg PA, Alessie JJ, Buijs MJ, Verhagen AP. Massage therapy has short-term benefits for people with common musculoskeletal disorders compared to no treatment: a systematic review. J Physiother. 2015 Jul;61(3):106-16. doi: 10.1016/j.jphys.2015.05.018. Epub 2015 Jun 17.
- Background: PubMed 17333123Senbursa G, Baltaci G, Atay A. Comparison of conservative treatment with and without manual physical therapy for patients with shoulder impingement syndrome: a prospective, randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):915-21. doi: 10.1007/s00167-007-0288-x. Epub 2007 Feb 28.
- Background: PubMed 9250771Bankes MJ, Emery RJ. An evaluation of the Constant-Murley shoulder assessment. J Bone Joint Surg Br. 1997 Jul;79(4):696. No abstract available.
- Background: PubMed 26160149Littlewood C, Bateman M, Brown K, Bury J, Mawson S, May S, Walters SJ. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study). Clin Rehabil. 2016 Jul;30(7):686-96. doi: 10.1177/0269215515593784. Epub 2015 Jul 9.
- Background: PubMed 26092288Page MJ, McKenzie JE, Green SE, Beaton DE, Jain NB, Lenza M, Verhagen AP, Surace S, Deitch J, Buchbinder R. Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials. J Clin Epidemiol. 2015 Nov;68(11):1270-81. doi: 10.1016/j.jclinepi.2015.06.006. Epub 2015 Jun 16.
- Derived from this study: PubMed 28857770Asensio-Garcia MDR, Bernabeu-Casas RC, Palazon-Bru A, Tomas-Rodriguez MI, Nouni-Garcia R. Effectiveness of a Group Physiotherapy Intervention in Nontraumatic, Inoperable Painful Shoulder: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2018 Feb;97(2):110-115. doi: 10.1097/PHM.0000000000000817.
- Individual participant dataSharing planned: Yes
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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.
M Rosario Asensio Garcia, Phd principal investigator
Universidad Miguel Hernández de Elche Alicante Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy exercises guideline in people with Shoulder Pain, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 3 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 25 Oct 2016. 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 Spain. 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?
Constant Murley Test (time frame: before/after intervention ( 6 weeks)). 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 NCT02541279, which also lists 6 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 25 Oct 2016.