Tight Control for Rotator Cuff Tendinopathy
ConditionRotator Cuff Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNantes University Hospital
About this trial
The main objective of the study is to determine whether tight management of patients in early rotator cuff tendinopathy would lead to better clinical improvement than standard management. In a randomized study, we propose to compare two types of management, with a tight control group having one consultation per month for the first 3 months, in order to readapt or intensify management, whereas the control group will only be seen at 3 months after inclusion. We hypothesize that this close follow-up will lead to more rapid clinical improvement and reduce the transition to chronicity and the associated costs (inclusion of a medico-economic analysis taking into account, in particular, healthcare consumption and time off work).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65
Shoulder pain on activity for less than 6 months with VAS≥4/10 and/or OSS≥20
Pain compatible with rotator cuff tendinopathy according to the rotator cuff tendinopathy according to the BESS (British Elbow and Shoulder Society) guidelines
Disqualifiers
Contraindication to steroid injections
Shoulder pain related to trauma (dislocation, fracture) or acute tendon rupture requiring short-term surgery
Steroid injection already performed on the shoulder studied for the current episode
Neurological pathology affecting the shoulder
Trial design
Design model
Parallel
Treatments tested in this trial
tight control management
Other interventionPatients will be seen every month for the first 3 months of follow-up During these consultations, shoulder pain and function will be assessed. Treatment adjustments (steroid injections, drugs and physiotherapy) will be proposed in line with predefined objectives.
standard follow-up
Other interventionPatients are monitored according to standard practice
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Tight control groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oxford Shoulder Score
Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)
Time frame
6 monthsSecondary outcomes
1
Oxford Shoulder Score
Functional score including 12 items rated between 0 and 4 (total score/48) (best score = 48)
Time frame
3 months and 12 months2
pain at motion
Visual Analogic Scale / 100 mm
Time frame
3 Months, 6 months, 12 months3
Pain Self-Efficacy Questionnaire
10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain.
Time frame
3 Months, 6 months, 12 months4
Insomnia Severity Index
7 item auto-questionnaire
Time frame
3 Months, 6 months, 12 monthsSponsors and contacts
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Source ClinicalTrials.gov