Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies

Shoulder Pain Clinical Trial

Official title:

Effectiveness of a Group Intervention for the Treatment of Shoulder Pathologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541279
• Other study ID #: 14/324
• Status: Completed
• Phase: N/A
• First received: July 31, 2015
• Last updated: October 24, 2016
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Physiotherapy exercises guideline
Exercises controlled by a physiotherapist.

Locations

Country	Name	City	State
Spain	Miguel Hernández de Elche	San Juan	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Hospital Universitario San Juan de Alicante

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Bankes MJ, Emery RJ. An evaluation of the Constant-Murley shoulder assessment. J Bone Joint Surg Br. 1997 Jul;79(4):696. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Murley Test	This test assesses daily activities.	before/after intervention ( 6 weeks)	No
Secondary	Quick-DASH Test	This test assesses functional limitation in upper limb musculoskeletal disorders.	before/after intervention ( 6 weeks)	No
Secondary	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'	before/after intervention ( 6 weeks)	No
Secondary	Measurement of the average force	Average force: Measurement was assessed in newtons	before/after intervention ( 6 weeks)	No