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Completed

NCT Number: NCT02631486

Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?

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.

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Key information

Conditions

Shoulder Rehabilitation Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wrightington Hospital

Wigan, Lancashire, WN6 9EP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy

Other

Passive exercises, active exercises, strengthening, stretching

Primary outcomes

  1. Change from baseline range of motion

    Time frame: 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

  1. Change from baseline muscle activity in millivolts

    Time frame: 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

    The muscle activity will be measured using non-invasive electromyography

  2. Re-tears ratio

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Collaborators

  • Wrightington, Wigan and Leigh NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 16, 2015
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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