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Completed

NCT Number: NCT02929433

Cycloergometer and Rotator Cuff Tear

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.

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Key information

Conditions

Rotator Cuff Tear Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cycloergometer

Other

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

Primary outcomes

  1. Visual Numeric Scale (VNS)

    Time frame: Change from Baseline VNS at 6 months after the out-patient rehabilitation

    The scale evaluated shoulder pain during activity

Secondary outcomes

  1. Constant-Murley scale

    Time frame: Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation

    The scale evaluated shoulder functionality

  2. Health Assessment Questionnaire (HAQ)

    Time frame: Change from Baseline HAQ at 6 months after the out-patient rehabilitation

    The Questionnaire evaluated Disability

Sponsors and collaborators

Lead sponsor

Fondazione Salvatore Maugeri

Other

Registry information

Official study title

Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 11, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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