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

NCT05886296 | Unknown DMC

• 1 other identifier: 01-23-280-028
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries; Surgery; Empowerment, Patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Shoulder Function

  baseline and 12 week

• Empowerment

  baseline

• Participants' Quality of Life perception

  baseline and 12 week

• Participant's satisfaction

  12 week

Study Arms (2)

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

EXPERIMENTAL

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.

Usual care

NO INTERVENTION

Participants will undergo usual care

Interventions

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. 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Patient Participation

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Maria Fornieles-Bagur

  Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Montserrat Grau-Pellicer, PhD

CONTACT

+34937003608; MGrauP@CST.CAT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 2, 2023
• Study Start: May 19, 2023
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)