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

Primary Purpose

Rotator Cuff Injuries, Surgery, Empowerment, Patient

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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.
Sponsored by
Consorci Sanitari de Terrassa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Consorci Sanitari de TerrassaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

pre-surgical information session for people who must undergo shoulder rotator cuff surgery

Usual care

Arm Description

implementation of an information session for people who have to undergo rotator cuff surgery of the shoulder on the post-operative evolution

Participants will undergo usual care

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
May 18, 2023
Last Updated
August 30, 2023
Sponsor
Consorci Sanitari de Terrassa
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1. Study Identification

Unique Protocol Identification Number
NCT05886296
Brief Title
Pre-surgical Information Session for People Who Must Undergo Shoulder Rotator Cuff Surgery
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Consorci Sanitari de Terrassa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Surgery, Empowerment, Patient

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pre-surgical information session for people who must undergo shoulder rotator cuff surgery
Arm Type
Experimental
Arm Description
implementation of an information session for people who have to undergo rotator cuff surgery of the shoulder on the post-operative evolution
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants will undergo usual care
Intervention Type
Behavioral
Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shoulder Functionality
Description
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)
Time Frame
baseline and 12 week
Secondary Outcome Measure Information:
Title
Shoulder Function
Description
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
Time Frame
baseline and 12 week
Title
Empowerment
Description
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
Time Frame
baseline
Title
Participants' Quality of Life perception
Description
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
Time Frame
baseline and 12 week
Title
Participant's satisfaction
Description
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
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Montserrat Grau-Pellicer, PhD
Phone
+34937003608
Email
MGrauP@CST.CAT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fornieles-Bagur
Organizational Affiliation
Consorci Sanitari de Terrassa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montserrat Grau-Pellicer, PhD
Phone
0034671631868
Email
MGrauP@CST.CAT
First Name & Middle Initial & Last Name & Degree
Montserrat Grau-Pellicer, PhD
Phone
0034937310007
Ext
1884
Email
mgraupellicer@fisioterapeutes.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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