Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies

October 24, 2016 updated by: María Isabel Tomás-Rodríguez, PT, Universidad Miguel Hernandez de Elche
The investigators determined the effectiveness of a group intervention for the treatment of shoulder pathologies.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alicante
      • San Juan, Alicante, Spain, 03550
        • Miguel Hernández de Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: M Rosario Asensio Garcia, Phd, Universidad Miguel Hernández de Elche Alicante Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 14/324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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