Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery

NCT06868472 | Not Yet Recruiting

• 1 other identifier: Ethics number: 150/2024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial is to investigate whether the intervention can improve the clinical outcome and patient satisfaction in elective reconstructive shoulder surgeries. The study participants are adults with a diagnosed rotator cuff tear for which surgical treatment is planned. This main question is to be answered by the study:

• Does prehabilitation before elective shoulder surgeries lead to an improvement in postoperative outcomes and patient satisfaction compared to the control group? The control group receives standard information about the hospital stay, while the intervention group undergoes the prehabilitation program in the approximately 6 weeks prior to surgery. This program includes:
• Information on the condition and pain management
• Recommendations for behavior modification
• A home exercise program Primary endpoint is the Western Ontario Rotator Cuff Index (WORC). The assessments are conducted at four time points: at study enrollment, immediately before surgery, and at 6, 12, and 24 months after surgery.

Conditions

Rotator Cuff

Keywords

Preoperative Exercise; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• Western Ontario Rotator Cuff Index (WORC)

  The WORC Index is a self-administered questionnaire designed to assess the quality of life in individuals with rotator cuff tendinopathy. It consists of 21 items across five domains: Physical Symptoms, Sports and Recreation, Work, Lifestyle, and Emotions. Each item is rated on a visual analogue scale (VAS) from 0 to 100. The total score ranges from 0 to 2100, which can be converted to a percentage for easier interpretation. A higher percentage indicates better shoulder function. The WORC Index is widely used in clinical settings to evaluate symptoms, functional limitations, and treatment outcomes.

  Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery

Secondary Outcomes (8)

• Patient survey on Treatment satisfaction and willingness to recommend

  before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery

• EQ-5D quality of life questionnaire

  Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery

• Constant Murely score for self-evaluation

  Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery

• Subjective shoulder value

  Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery

• Survey on the use of painkillers

  Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery

Study Arms (2)

Prehabilitation-Group

ACTIVE COMPARATOR

Procedure: Prehabilitation

Control-Group

PLACEBO COMPARATOR

Procedure: Control

Interventions

Prehabilitation PROCEDURE

The waiting time until the operation is about 6 weeks. The intervention is carried out during this time: The intervention group receives a brochure with an evidence-based exercise program for the shoulder and shoulder girdle. The brochure contains pages in which the patient documents how the exercises are carried out. The exercise program is supplemented by information in the form of a video/Power Point presentation on: Anatomy/function, pain management, hospitalization and subsequent rehabilitation. After 2 and after 4 weeks, the physiotherapist who has explained the exercise program will contact you by telephone/zoom.

Prehabilitation-Group

Control PROCEDURE

The control group receives a leaflet with general information for the period up to the operation (e.g. buy water-resistant plasters, arrange post-op physiotherapy appointments).

Control-Group

Eligibility Criteria

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

You may qualify if:

• Patients with a traumatic or degenerative rupture of the rotator cuff with whom surgical treatment has been discussed in the shoulder clinic.

You may not qualify if:

• Pre-existing fracture of the upper arm or shoulder girdle, rheumatic arthritis/fibromyalgia, additional findings in the shoulder joint (instability, frozen shoulder), neurological disease, cognitive or speech impairment

Sponsors & Collaborators

• Prof. Arasch Wafaisade: lead

Study Sites (1)

Kliniken der Stadt Köln gGmbH

Cologne, 51067, Germany

Location

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Arasch Wafaisade, Prof. Dr. med.

CONTACT

+49-221-8907-18600; WafaisadeA@kliniken-koeln.de

Ute Westphal

CONTACT

+49-221-8907-2421; Westphalu@kliniken-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 11, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)