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Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?

Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02631486
Enrollment
20
Registered
2015-12-16
Start date
2016-04-30
Completion date
2018-07-31
Last updated
2019-04-18

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

Conditions

Rehabilitation, Shoulder

Keywords

Rotator Cuff Tears

Brief summary

Shoulder pain is among the most common musculoskeletal complaints, leading to high number of General Practioners consultations in the United Kingdom. On the top list of the disorders causing pain and dysfunction of shoulder is rotator cuff tears. The aetiology of rotator cuff tears is multifactorial and is likely to be a combination of age-related degenerative changes and trauma during life. It is present in approximately 25% of individuals in their 60s and 50% of individuals in their 80s and have been shown to start developing during the 40s. To recover functional status of this patients group, surgical repair is often recommended, but for optimal results the rehabilitation is of great importance and must be adequately planned. After surgery a period of movement restriction is followed, however, the optimal time of immobilisation is unknown. As a common practice, patients use a sling for six weeks and avoid any activities with the affected shoulder. This period is important to protect the tendon, allow good healing and to possibly prevent re-tear episodes. Although, the delayed motion may increase the risk of postoperative shoulder stiffness, muscle atrophy and potentially delay improvement of functionality. Based on the available evidence, it is difficult to make a clinical decision for a well-programmed rehabilitation regime and establish the most favourable postoperative time to start it. Moreover, it is not clear if early mobilisation will benefit more severe stages as published studies have methodological flaws that compromises the clinical decision for patients with higher commitments. The question whether early mobilisation application is beneficial is of high importance as the results will not just help improving patients quality of life, but also may reduce costs as further complication may be avoided.

Detailed description

The study will be a randomised controlled trial, which means that each participant will have equal chances to be assigned to one of 2 groups. The first group will start the rehabilitation after 3 weeks post-surgery and the second group will start after 6 weeks. The rehabilitation stages will start with passive movements, progressing to more active stages phases until full recovery. The whole program will last about 3 months, which is in accordance to what is normally used at the Wrightington Hospital. Each participant will have 4 assessment sessions: 1 pre-surgery, after 3 months post-surgery, after 6 months and the last after 12 months post-surgery. The assessment sessions will consist on answering questionnaires and a clinical assessment with equipment, which measures muscle activity and joint angles during clinical tasks. An ultrasound scan of the shoulder to assess the integrity of the rotator cuff would be carried out one year after surgery by a consultant radiologist. These assessments are timed with the routine orthopaedic clinic assessments so that patients do not have to make extra trips to take part in the research.

Interventions

OTHERPhysiotherapy

Passive exercises, active exercises, strengthening, stretching

Sponsors

Wrightington, Wigan and Leigh NHS Foundation Trust
CollaboratorOTHER
University of Central Lancashire
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age between 40 and 70 years old, * Confirmed diagnosis of rotator cuff tear * No previous shoulder surgery * No other musculoskeletal impairment in the assessed limb or cervical and thoracic spine.

Exclusion criteria

* Previous shoulder surgery * Fixation which does not allow early mobilisation * Other musculoskeletal impairment in the assessed limb or cervical and thoracic spine, * People with special needs who are unable to understand the instructions needed, * Non-English or non-Portuguese speakers.

Design outcomes

Primary

MeasureTime frame
Change from baseline range of motionPre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year

Secondary

MeasureTime frameDescription
Change from baseline muscle activity in millivoltsPre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 yearThe muscle activity will be measured using non-invasive electromyography
Re-tears ratio1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026