Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?

NCT02631486 | Completed DMC

• 1 other identifier: STEMH 277
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder; Rehabilitation

Keywords

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Change from baseline range of motion

  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 (2)

• Change from baseline muscle activity in millivolts

  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

• Re-tears ratio

  1 year

Study Arms (2)

Early

EXPERIMENTAL

The first group will use sling for comfort only. Active assisted exercises in closed chain and in safe zone are allowed in the first 4 weeks. The rehabilitation stages will start from active assisted progressing to more active stages phases until full recovery. The whole program will last about 3 months.

Other: Physiotherapy

Conservative

ACTIVE COMPARATOR

The second group will use a sling for 6 weeks. The rehabilitation stages will start with active assisted/closed chain movements with short levers, it will progress to more active stages phases until full recovery. The whole program will last about 3 months.

Other: Physiotherapy

Interventions

Physiotherapy OTHER

Passive exercises, active exercises, strengthening, stretching

Conservative; Early

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Lancashire: lead
• Wrightington, Wigan and Leigh NHS Foundation Trust: collaborator

Study Sites (1)

Wrightington Hospital

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Jim Richards, Professor

  University of Central Lancashire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 16, 2015
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)