NCT04458025: RAPIDREHAB

Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.

Status unknown NA Last updated 7 July 2020

What this trial tests

NA trial testing Standard rehabilitation program in Rotator Cuff Tear Repair in 64 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
30 September 2023

31 December 2023

Quick facts

Lead sponsor	Borja Alcobía-Díaz MD, PhD
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	1 September 2020
Primary completion	30 September 2023
Estimated completion	31 December 2023

Drugs / interventions tested

• Standard rehabilitation program
• Early rehabilitation program

Conditions studied

• Rotator Cuff Tear Repair — all drugs for Rotator Cuff Tear Repair →

Sponsor

Borja Alcobía-Díaz MD, PhD

Who can join

Adults 18 to 70, any sex, with Rotator Cuff Tear Repair. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Arthroscopic suture for complete and partial \>50% thickness Rotator Cuff Tears (RCT) is the gold standard. However, there is no evidence of superiority of delayed postoperative mobilization protocols versus early ones, in terms of ROM, pain, quality of life and complications in last review published in 2019 by AAOS. Although, excessive immobilization can lead into stiffness, neuropathic pain or adhesive capsulitis. All of these are complications which can diminish patient quality of life or prolong their return to work or sports activities.

This is an experimental, prospective, non-blind, comparative, randomized clinical trial, between two options of treatment. On one treatment branch, we will continue applying our standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation. On the other treatment branch, we will start passive mobilization during second week after surgery, including controlled external rotation movements. All recruited patients will be followed-up during 12 months.

Our main objective is to compare differences in terms of functionality (using ASES scale). Secondary objectives are to compare differences in terms of ROM, functionality (using CMS and UCLA scales), pain (using VAS score), need of analgesic drugs, quality of life (using EQ-5D scale), return to previous work and sports activities, patient adhesion to protocol, complications and MRI rotator cuff retear ratio at 12 months follow-up.

After this study, we hope to develop a new postoperative mobilization protocol for patients. This protocol will be focused on timing, and self-administrated exercises in order to involve patients in their recovery, in the fastest and safest way for them.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.