Pre-surgical Information Session for People Who Must Undergo Shoulder Rotator Cuff Surgery

Evaluation of the Impact of a Pre-surgical Information Session for People Who Must Undergo Shoulder Rotator Cuff Surgery on Empowerment for Their Functional Rehabilitation Process.

The shoulder is the most mobile joint in the human body. Movements are carried out in most of the activities we participate in, such as work, sports, household tasks, shopping and leisure activities. Shoulder diseases affect 21% of the western population and is one of the most frequent reasons for consultation in orthopedics and rehabilitation consultations.

Shoulder pain is in a large majority of cases related to the slope of the acromion and rotator cuff pathology, which would include the slope of the acromion syndrome. The degree of involvement can range from bursitis, tendinitis, to tendinous ruptures.

Initial treatment is usually conservative and may consist of anti-inflammatory medication and rehabilitation. When the pain is not relieved, surgery is usually recommended. Surgery for rotator cuff tears is increasingly performed minimally invasive, using arthroscopy.

Hospital admission days are currently being reduced, so many of the scheduled shoulder surgeries are performed via the Outpatient Surgery Unit. Often, users are not seen again by the surgeon until a week after the intervention. The affected person must empower themselves and participate actively and progressively in their recovery process. This process begins right after the surgical intervention. Therefore, it is very important that the person has all the necessary information about the surgical procedure that has been performed. Patient education is crucial to reduce anxiety and optimize surgical outcomes.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Surgery; Empowerment, Patient
• Intervention / Treatment: Behavioral: Evaluation of the impact of a pre-surgical information session for people who must undergo shoulder rotator cuff surgery on empowerment for their functional rehabilitation process.

Detailed Description

This is a randomized clinical trial with an intervention group (IG) and a control group (CG). As participants are visited by orthopedic surgery, they are referred to rehabilitation. Once in rehabilitation and in order of arrival of the rehabilitation requests, the participants will be randomized into groups of 8 people/week in the IG and the CG. The first group of 8 people will be IG and the following week the second group of 8 people will be CG and so on until reaching the required sample.

The intervention will take place at the Rehabilitation Unit of the Consorci Sanitari de Terrassa

Participants will be anonymized and randomized into two groups: IG and CG. All participants will receive detailed information about the surgical procedure to which they will be subjected during the pre-surgical visit, carried out by the doctor specializing in orthopedic surgery. The information received will include risks and benefits and all participants will be able to ask any questions they may have. The IG will participate in an informational session prior to shoulder surgery. The session aims to: (1) Know the anatomy and functionality of the shoulder, (2) Understand why pain and functional disability appear, (3) Learn what to do to reduce symptoms, (4) Empower people to face the rehabilitation process. The CG will receive the usual rehabilitation protocol at the Consorci Sanitari de Terrassa, which begins three weeks after the surgical intervention.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Montserrat Grau-Pellicer, PhD; Phone Number: +34937003608; Email: MGrauP@CST.CAT

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain
      • Recruiting
      • Consorci Sanitari de Terrassa
      • Contact: Montserrat Grau-Pellicer, PhD; Phone Number: 0034671631868; Email: MGrauP@CST.CAT
      • Contact: Montserrat Grau-Pellicer, PhD; Phone Number: 1884 0034937310007; Email: mgraupellicer@fisioterapeutes.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• People who need shoulder surgery for shoulder rotator cuff pathology
• Over 18 years old
• Understand Spanish or Catalan
• Acceptance of informed consent

Exclusion Criteria:

• People who have already received previous surgery on the same shoulder
• People who have had previous infections in the same shoulder
• Neurological deficits and/or presence of tumors
• People with visual or cognitive deficits that prevent them from following the information session

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pre-surgical information session for people who must undergo shoulder rotator cuff surgery; implementation of an information session for people who have to undergo rotator cuff surgery of the shoulder on the post-operative evolution	Behavioral: Evaluation of the impact of a pre-surgical information session for people who must undergo shoulder rotator cuff surgery on empowerment for their functional rehabilitation process.; To evaluate the effect of the implementation of an information session for people who have to undergo rotator cuff surgery of the shoulder on the post-operative evolution of functionality, quality of life, empowerment and self-efficacy in the three months of the surgical intervention.
No Intervention: Usual care; Participants will undergo usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Functionality	Change of shoulder function from baseline to 12 weeks assessed with Constant Test (Maximum Score is 100 and it means the best function of the shoulder. Minimum Score is 0 and it means the worse function of the shoulder)	baseline and 12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Function	Change of shoulder functionality from baseline to 12 weeks assessed with American Shoulder and Elbow Score (ASES Score). Maximum Score is 10 and it means the best function of the shoulder. Minimum Score is 0 and it means the worse function of the shoulder	baseline and 12 week
Empowerment	Ad-hoc self-efficacy perception questionnaire. Maximum Score is 60 and it means the best self-efficacy perception. Minimum Score is 0 and it means the worse self-efficacy perception	baseline
Participants' Quality of Life perception	Change of participant's Quality of life perception, assessed with the Euroquol questionnarie. Maximum Score is 25 and it means the best worse participant's Quality of Life perception. Minimum Score is 0 and it means the best participant's Quality of Life perception	baseline and 12 week
Participant's satisfaction	Ad-hoc participant's satisfaction perception questionnaire. Maximum Score is 45 and it means the best participant's satisfaction. Minimum Score is 0 and it means the worse participant's satisfaction	12 week

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa
• Investigators: Principal Investigator: Maria Fornieles-Bagur, Consorci Sanitari de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 01-23-280-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No