Back to resultsEffectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy exercises guideline
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
Eligibility Criteria
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.
Sites / Locations
- Miguel Hernández de Elche
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
The intervention group received 6 sessions of shoulder exercises controlled by a physiotherapist.
The control group received a paper explaining the same exercises which were performed by the intervention group. This group made the exercises at home.
Outcomes
Primary Outcome Measures
Constant Murley Test
This test assesses daily activities.
Secondary Outcome Measures
Quick-DASH Test
This test assesses functional limitation in upper limb musculoskeletal disorders.
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'
Measurement of the average force
Average force: Measurement was assessed in newtons
Full Information
NCT ID
NCT02541279
First Posted
July 31, 2015
Last Updated
October 24, 2016
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Hospital Universitario San Juan de Alicante
1. Study Identification
Unique Protocol Identification Number
NCT02541279
Brief Title
Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
Official Title
Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Hospital Universitario San Juan de Alicante
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group received 6 sessions of shoulder exercises controlled by a physiotherapist.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group received a paper explaining the same exercises which were performed by the intervention group. This group made the exercises at home.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy exercises guideline
Intervention Description
Exercises controlled by a physiotherapist.
Primary Outcome Measure Information:
Title
Constant Murley Test
Description
This test assesses daily activities.
Time Frame
before/after intervention ( 6 weeks)
Secondary Outcome Measure Information:
Title
Quick-DASH Test
Description
This test assesses functional limitation in upper limb musculoskeletal disorders.
Time Frame
before/after intervention ( 6 weeks)
Title
Pain NRS (numeric rating scale)
Description
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'
Time Frame
before/after intervention ( 6 weeks)
Title
Measurement of the average force
Description
Average force: Measurement was assessed in newtons
Time Frame
before/after intervention ( 6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Rosario Asensio Garcia, Phd
Organizational Affiliation
Universidad Miguel Hernández de Elche Alicante Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miguel Hernández de Elche
City
San Juan
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
26093806
Citation
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.
Results Reference
background
PubMed Identifier
17333123
Citation
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.
Results Reference
background
PubMed Identifier
9250771
Citation
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.
Results Reference
background
PubMed Identifier
26160149
Citation
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.
Results Reference
background
PubMed Identifier
26092288
Citation
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.
Results Reference
background
PubMed Identifier
28857770
Citation
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.
Results Reference
derived
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Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies
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