- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541279
Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alicante
-
San Juan, Alicante, Spain, 03550
- Miguel Hernández de Elche
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-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).
Exclusion Criteria:
- Patients who cannot perform the exercises correctly (example: psychiatry disorders)
- Patients with Shoulder surgery
- Patients whose shoulder pain is above 7 according VAS pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The intervention group received 6 sessions of shoulder exercises controlled by a physiotherapist.
|
Exercises controlled by a physiotherapist.
|
Active Comparator: Control
The control group received a paper explaining the same exercises which were performed by the intervention group.
This group made the exercises at home.
|
Exercises controlled by a physiotherapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constant Murley Test
Time Frame: before/after intervention ( 6 weeks)
|
This test assesses daily activities.
|
before/after intervention ( 6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quick-DASH Test
Time Frame: before/after intervention ( 6 weeks)
|
This test assesses functional limitation in upper limb musculoskeletal disorders.
|
before/after intervention ( 6 weeks)
|
Pain NRS (numeric rating scale)
Time Frame: before/after intervention ( 6 weeks)
|
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'
|
before/after intervention ( 6 weeks)
|
Measurement of the average force
Time Frame: before/after intervention ( 6 weeks)
|
Average force: Measurement was assessed in newtons
|
before/after intervention ( 6 weeks)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: M Rosario Asensio Garcia, Phd, Universidad Miguel Hernández de Elche Alicante Spain
Publications and helpful links
General 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.
- Senbursa 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.
- Bankes MJ, Emery RJ. An evaluation of the Constant-Murley shoulder assessment. J Bone Joint Surg Br. 1997 Jul;79(4):696. No abstract available.
- Littlewood 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.
- Page 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.
- Asensio-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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Pain
-
Helping Hand Institute of Rehabilitation SciencesRecruitingShoulder Injuries | Shoulder Capsulitis | Shoulder Arthritis | Shoulder Impingement | Shoulder Bursitis | Shoulder Pain ChronicPakistan
-
University of Southern DenmarkRegion of Southern Denmark; The Danish Rheumatism Association; Esbjerg Municipality and other collaboratorsCompletedHypermobility Syndrome Shoulder | Shoulder Pain Chronic | Shoulder LuxationDenmark
-
Oslo University HospitalUnknownShoulder Impingement Syndrome | Subacromial Shoulder PainNorway
-
Şeyhmus KAPLANCompletedSubacromial Impingement | Pain, Shoulder
-
Istanbul University - Cerrahpasa (IUC)Istanbul Aydın UniversityCompletedPain, Shoulder | Myofacial Pain | Adhesion; ShoulderTurkey
-
Helping Hand Institute of Rehabilitation SciencesCompletedShoulder Injuries | Shoulder Pain | Shoulder Capsulitis | Frozen Shoulder | Shoulder ImpingementPakistan
-
Mohamed R El TahanCompletedUnilateral Chronic Shoulder Pain | Bilateral Chronic Shoulder PainEgypt
-
Hasan Kalyoncu UniversityHacettepe UniversityCompletedShoulder Pain | Shoulder Injury | Shoulder ImpingementTurkey
-
Makassed General HospitalRecruiting
-
Zagazig UniversityCompleted
Clinical Trials on Physiotherapy exercises guideline
-
Karolinska InstitutetCompleted
-
University of EdinburghArthritis Research UKCompletedOsteoarthritis of the KneeUnited Kingdom
-
University of MaltaCompleted
-
Emilia Nozawa, PT PhDUniversity of Sao PauloCompletedCoronary Artery Disease | Cardiovascular Infections | Mediastinitis
-
King Saud UniversityCompleted
-
Uskudar UniversityCompletedChronic Pain | Neck Pain | Temporomandibular Joint Disorders | Temporomandibular Joint Dysfunction SyndromeTurkey
-
Hacettepe UniversityCompleted
-
Universidad de GranadaCompletedChronic Obstructive Pulmonary DiseaseSpain
-
Karolinska InstitutetCompleted