Clinical trial NCT02631486: Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
Official title: Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder
Rehabilitation
Keywords: Rotator Cuff Tears
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
Collaborators: name: Wrightington, Wigan and Leigh NHS Foundation Trust
First posted: 2015-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline range of motion
timeFrame: Pre-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 outcomes:
measure: Change from baseline muscle activity in millivolts
timeFrame: Pre-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
measure: Re-tears ratio
timeFrame: 1 year
Other outcomes:
Locations:
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
state: Lancashire
Study officials:
affiliation: University of Central Lancashire
name: Jim Richards, Professor
role: PRINCIPAL_INVESTIGATOR
References: