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CompletedNCT02541279Updated Oct 25, 2016

Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies

An interventional study of Physiotherapy exercises guideline in Shoulder Pain, sponsored by Universidad Miguel Hernandez de Elche. Completed at 1 site in Spain. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-25.

Sponsored by Universidad Miguel Hernandez de Elche · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Shoulder Pain

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 76 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Universidad Miguel Hernandez de Elche is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Intervention

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

    Procedure: Physiotherapy exercises guideline

  • 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.

    Procedure: Physiotherapy exercises guideline

Interventions

  • ProcedurePhysiotherapy exercises guideline

    Exercises controlled by a physiotherapist.

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What researchers measure

Primary outcomes

  1. Constant Murley Test

    This test assesses daily activities.

    Time frame: before/after intervention ( 6 weeks)

Secondary outcomes

  1. Quick-DASH Test

    This test assesses functional limitation in upper limb musculoskeletal disorders.

    Time frame: before/after intervention ( 6 weeks)

  2. 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'

    Time frame: before/after intervention ( 6 weeks)

  3. Measurement of the average force

    Average force: Measurement was assessed in newtons

    Time frame: before/after intervention ( 6 weeks)

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Study locations

1 site
  • Miguel Hernández de Elche
    San Juan, Alicante 03550, Spain
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References and documents

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 26093806 ↗
  • 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. PubMed 17333123 ↗
  • 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. PubMed 9250771 ↗
  • 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. PubMed 26160149 ↗
  • 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. PubMed 26092288 ↗
  • 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. PubMed 28857770 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02541279
Lead sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Hospital Universitario San Juan de Alicante
Responsible party
María Isabel Tomás-Rodríguez, PT (PT MSC, Universidad Miguel Hernandez de Elche) — Principal investigator
First posted
Sep 4, 2015
Start date
Nov 2014
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Oct 25, 2016

Study contacts

M Rosario Asensio Garcia, Phd
principal investigator · Universidad Miguel Hernández de Elche Alicante Spain

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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