Rotator CuffPrehabNCT06868472
Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery
A study testing Prehabilitation in people with Rotator Cuff, run by Prof. Arasch Wafaisade at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff
- What is being tested?
- Prehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 18 Mar 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a traumatic or degenerative rupture of the rotator cuff with whom surgical treatment has been discussed in the shoulder clinic.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Kliniken der Stadt Köln gGmbH
Cologne, 51067
Arasch Wafaisade, Prof. Dr. med., +49221 890718600, WafaisadeA@kliniken-koeln.de
Ute Westphal, +49221 89072429, Westphalu@kliniken-koeln.de
About this study
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?
Read more
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
- Being tested
- Prehabilitation, Control
- Keywords
- Preoperative Exercise, Enhanced Recovery After Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationProcedure or surgery
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.
ControlProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation-Group | Active comparator | Not described Receives: Procedure: Prehabilitation |
| Control-Group | Placebo comparator | Not described Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A brief, self-designed questionnaire was developed to measure overall satisfaction through patient satisfaction and willingness to recommend. It utilizes a 6-point Likert scale for responses.
Measured: before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
EQ-5D quality of life questionnaire
The EQ-5D is a standardized questionnaire developed by the EuroQol Research Foundation to measure health-related quality of life. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a scale of severity. Additionally, it includes a visual analogue scale (EQ VAS) for the patient's self-rated health. The EQ-5D is widely used in clinical studies, health economics, and routine care to assess and compare quality of life across different health conditions and populations. It provides a simple, reliable, and internationally recognized tool for evaluating overall health status.
Measured: 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
The Constant-Murley Score for self-evaluation, adapted by Boehm et al. in 2003, is a modified version of the original Constant-Murley Score that allows patients to independently assess their shoulder function. It includes parameters such as pain, activities of daily living, range of motion, and strength, scored on a standardized scale. This self-assessment tool provides a reliable and practical method for patients to evaluate their shoulder condition, enabling its use in clinical research and routine monitoring of treatment outcomes.
Measured: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Subjective shoulder value
The Subjective Shoulder Value (SSV) is a patient-reported numeric scale that reflects the subjective assessment of shoulder function. Patients rate their current shoulder function as a percentage compared to a normal, healthy shoulder, with 0% representing no function and 100% representing full, unrestricted function. Developed by Gilbart and Gerber in 2007, the SSV is a simple, quick, and reliable tool for evaluating subjective shoulder functionality. It is widely used in clinical studies and daily practice to monitor progress and document outcomes in shoulder conditions.
Measured: 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
Measured: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Survey on return to pre-operative sport
Patients are asked whether they have resumed the sport they practiced before the operation and at what level of performance they have returned (same level, slightly reduced, significantly reduced or no sport). In addition, it is recorded whether the sport is an overhead sport.
Measured: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Survey on return to preoperative occupation or daily responsibilities
Patients are asked whether they have returned to their preoperative occupation or daily responsibilities. Additionally, it is recorded whether their work involves a desk job."
Measured: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Examination for the presence of a re-rupture
It is recorded whether a re-rupture has occurred postoperatively.
Measured: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start18 Mar 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator CuffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Arasch Wafaisade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Arasch Wafaisade, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868472
- Sponsor's protocol ID
- Ethics number: 150/2024
- Acronym
- Prehab
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06868472
- Acronym / sponsor ID
- Prehab / Ethics number: 150/2024
- Conditions
- Rotator Cuff
- Keywords
- Preoperative Exercise, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Prof. Arasch WafaisadeUniversity, hospital or other
- Study start
- 18 Mar 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation-Group | Active comparator | Procedure: Prehabilitation |
| Control-Group | Placebo comparator | Procedure: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a traumatic or degenerative rupture of the rotator cuff with whom surgical treatment has been discussed in the shoulder clinic.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationThe 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. | Procedure or surgery | Prehabilitation-Group |
| ControlThe 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). | Procedure or surgery | Control-Group |
Primary outcome
Western Ontario Rotator Cuff Index (WORC)
Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
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.
8 secondary outcomes
Patient survey on Treatment satisfaction and willingness to recommend
Time frame: before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
EQ-5D quality of life questionnaire
Time frame: 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
Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Subjective shoulder value
Time frame: 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
Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Survey on return to pre-operative sport
Time frame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Survey on return to preoperative occupation or daily responsibilities
Time frame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Examination for the presence of a re-rupture
Time frame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Recruiting
Which Patient Group Shows Greater Improvement With Patient Education Alone in Rotator Cuff-Related Shoulder Pain? - A Cohort Study
Shoulder Pain Syndrome, Subacromial Pain Syndrome
Active, not recruiting
Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, and Function
Shoulder Pain and Stiffness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Rotator Cuff, run by Prof. Arasch Wafaisade at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arasch Wafaisade, Prof. Dr. med. (+49-221-8907-18600, WafaisadeA@kliniken-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index (WORC) (time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.