Cycloergometer and Rotator Cuff Tear

Rotator Cuff Tear Clinical Trial

Official title:

Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929433
• Other study ID #: cts 2012-13
• Status: Completed
• Phase: N/A
• First received: September 28, 2016
• Last updated: October 7, 2016
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2016
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. The cycloergometer has been already employed in many fields of medicine.

However, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in Rotator Cuff Tear patients.

Description:

To evaluate the effects of cycloergometer on pain during activities (primary outcome) and shoulder functionality, the investigators performed a prospective randomized controlled study (pilot study) in patients with a symptomatic full-thickness RCT.

Since cycloergometer works through a continuous active and passive joint mobilization, the investigators expect it can reduce pain and improve shoulder functionality becoming a useful tool for physicians in the management of RCT patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• positive imaging diagnosis of full-thickness RCT

• surgery not considered as the first treatment of choice

• willingness to sign the informed consent form.

Exclusion Criteria:

• inflammatory rheumatic diseases

• history of fracture or operations around the shoulder region

• neurological diseases

• infections or tumours

• diabetes

• coagulation diseases

• intra-articular injections of the involved shoulder within the last 12 months.

Study Design

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

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Other:
• Cycloergometer
Daily training of the RCT patients was provided by the use of a cycloergometer at home. Educational support once a month was guaranteed by a nurse of the telemedicine service

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Numeric Scale (VNS)	The scale evaluated shoulder pain during activity	Change from Baseline VNS at 6 months after the out-patient rehabilitation	Yes
Secondary	Constant-Murley scale	The scale evaluated shoulder functionality	Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation	Yes
Secondary	Health Assessment Questionnaire (HAQ)	The Questionnaire evaluated Disability	Change from Baseline HAQ at 6 months after the out-patient rehabilitation	Yes