NCT02541279

Brief Summary

The investigators determined the effectiveness of a group intervention for the treatment of shoulder pathologies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

8 months

First QC Date

July 31, 2015

Last Update Submit

October 24, 2016

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

  • Constant Murley Test

    This test assesses daily activities.

    before/after intervention ( 6 weeks)

Secondary Outcomes (3)

  • Quick-DASH Test

    before/after intervention ( 6 weeks)

  • Pain NRS (numeric rating scale)

    before/after intervention ( 6 weeks)

  • Measurement of the average force

    before/after intervention ( 6 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group received 6 sessions of shoulder exercises controlled by a physiotherapist.

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.

Procedure: Physiotherapy exercises guideline

Interventions

Physiotherapy exercises guidelinePROCEDURE

Exercises controlled by a physiotherapist.

ControlIntervention

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Patients who cannot perform the exercises correctly (example: psychiatry disorders)
  • Patients with Shoulder surgery
  • Patients whose shoulder pain is above 7 according VAS pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Hernández de Elche

San Juan, Alicante, 03550, Spain

Location

Related Publications (6)

  • 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.

    PMID: 26093806BACKGROUND

  • 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.

    PMID: 17333123BACKGROUND

  • 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.

    PMID: 9250771BACKGROUND

  • 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.

    PMID: 26160149BACKGROUND

  • 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.

    PMID: 26092288BACKGROUND

  • 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.

    PMID: 28857770DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • M Rosario Asensio Garcia, Phd

    Universidad Miguel Hernández de Elche Alicante Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT MSC

Study Record Dates

First Submitted

July 31, 2015

First Posted

September 4, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

ES(1)