NCT07360847

Brief Summary

Shoulder pain from rotator cuff disorders is common, affecting function and quality of life. Many patients in orthopaedic clinics are diagnosed with these conditions. Most do not need surgery and are treated with pain relief and physiotherapy. However, long physiotherapy waitlists cause delays, and some patients do not achieve good outcomes. There is limited evidence to predict who will recover well with non-surgical care. A cohort study at Croom Orthopaedic Hospital is proposed to explore this. Patients assessed as suitable for non-surgical care by the shoulder physiotherapist will provide consent and complete questionnaires on pain, disability, quality of life, and personal factors like age and gender. They will continue with prescribed care and repeat the questionnaires after six months. This study will identify factors predicting successful outcomes, improving treatment programs to better meet patients' needs. It is funded by the Irish Research Council and led by Professors Karen McCreesh and Rose Galvin, UL, and Mr. Tristan Cassidy, Orthopaedic Consultant. Collaborators include Catriona Foley, shoulder specialist physiotherapist at Croom.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Nov 2027

Study Start

First participant enrolled

January 5, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

January 13, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

RCRSPRotator Cuff Related Shoulder PainNon-operativePrognosisPrognostic Factor

Outcome Measures

Primary Outcomes (3)

  • Pain Visual Analogue Scale (VAS)

    Pain level on a scale from 0-10. 0 = no pain, 10 = worst pain. higher number = worse

    From enrollment to six month follow up

  • Shoulder Pain and Disability Index (SPADI)

    Shoulder Pain and Disability Index measures a patient's self-perceived pain and functional limitations due to shoulder problems. 0 = no pain/disability 100 = maximum pain/disability Higher scores = worse outcome

    From enrollment to six month follow up

  • Western Ontario Rotator Cuff Index (WORC)

    Western Ontario Rotator Cuff Index measures the impact of rotator cuff conditions on a person's quality of life. Scored from 0-2100. 0 = best (no impairment) 2100 = worst (maximum impairment)

    From enrollment to six month follow up

Study Arms (1)

Non-operatively managed Rotator Cuff Related Shoulder Pain patients

Non-operatively managed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults who present to the Specialist Shoulder clinic at Croom Orthopaedic Hospital between January 2026 and January 2027 (inclusive) will be considered eligible for inclusion to the study provided that they meet the inclusion criteria outlined above.

You may qualify if:

  • Adults
  • Clinically diagnosed Rotator Cuff Related Shoulder Pain (disorder of the rotator cuff muscles and/or sub acromial space).
  • Being referred to primary care physiotherapy or other non-surgical management.

You may not qualify if:

  • Under 18
  • Non-rotator cuff related pathologies of the shoulder such as fractures, frozen shoulder, concomitant neck pain.
  • Person undergoing shoulder surgery.
  • Neither the patient nor carer can communicate in English sufficiently to complete consent or baseline assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croom Orthopaedic Hospital

Limerick, Ireland

RECRUITING

Central Study Contacts

Roisin Cahill, MSc Physiotherapy

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations