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

NCT ID: NCT05886296

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Injuries Surgery Empowerment, Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

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 Type BEHAVIORAL

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.

Usual care

Participants will undergo usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Montserrat Grau-Pellicer

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Fornieles-Bagur

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de Terrassa

Locations

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Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Montserrat Grau-Pellicer, PhD

Role: CONTACT

+34937003608

Facility Contacts

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Montserrat Grau-Pellicer, PhD

Role: primary

0034671631868

Montserrat Grau-Pellicer, PhD

Role: backup

0034937310007 ext. 1884

Other Identifiers

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01-23-280-028

Identifier Type: -

Identifier Source: org_study_id

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