A randomized controlled trial to determine whether injection before physiotherapy improves the outcome for massive rotator cuff tears and which muscles are used to replace the rotator cuff in patients with good function and known massive cuff tear

Randomized controlled trial to determine whether injection prior to physiotherapy improves the outcome for large to massive rotator cuff tears: which muscles are used to replace the rotator cuff in patients with good function and known large massive cuff tear, and does the location of the tear affect outcomes?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17324599

Enrollment

Registered

2024-10-22

Start date

2015-04-20

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Massive rotator cuff tears in the shoulder Musculoskeletal Diseases

Interventions

Randomized controlled trial: Patients with an acute cuff tear of 3 cm or more of age 65 years and who met other recruitment criteria were offered the opportunity to take part in the study to test the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age over 65 years 2. Acute massive cuff tears (onset within 6 months) 3. Massive cuff tear confirmed by ultrasound scan (>3 cm) 4. Weakness of shoulder external rotation 5. Painful shoulder 6. Limited range of movement actively (<90 degrees elevation)

Exclusion criteria

Exclusion criteria: 1. Patients under 65 years of age 2. Patients not able to exercise due to medical reasons 3. Previous surgery to the shoulder 4. Patients with poor comprehension using the mini-mental score 5. Previous physiotherapy for the same condition 6. Patients currently undergoing physiotherapy for the same condition 7. Patients with multiple joint pathologies 8. Patients unable to comply with daily exercise and weekly appointments due to other commitments 9. Passive stiffness 10. Chronic tears with no acute increase in pain 11. Needle phobia

Design outcomes

Primary

Measure	Time frame
Shoulder pain and function were measured using the Oxford Shoulder score prior to treatment starting and at 6 months or the end of treatment, whichever was earlier	—

Secondary

Measure	Time frame
1. The EMGs of the muscles around the shoulders were measured using a wireless EMG system using sensor locations according to SENIAM guidelines. Data was recorded at 2000 Hz via Delys EMG Works software. Prior to data collection of five functional tasks of five repetitions, each patient performed a maximal effort resistive task to determine their maximal voluntary contraction for each of 13 muscles examined. Measurements were taken prior to the start of treatment and at the end of treatment. 2. The location of the rotator cuff tears in the shoulder was measured by ultrasound prior to recruitment into the study.	—

Measure

Time frame

1. The EMGs of the muscles around the shoulders were measured using a wireless EMG system using sensor locations according to SENIAM guidelines. Data was recorded at 2000 Hz via Delys EMG Works software. Prior to data collection of five functional tasks of five repetitions, each patient performed a maximal effort resistive task to determine their maximal voluntary contraction for each of 13 muscles examined. Measurements were taken prior to the start of treatment and at the end of treatment. 2. The location of the rotator cuff tears in the shoulder was measured by ultrasound prior to recruitment into the study.

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Countries

England, United Kingdom

Contacts

Public ContactAlison Armstrong

alison.armstrong@uhl-tr.nhs.uk+44 (0)1162588112

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026