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Completed

NCT Number: NCT02813304

Comparison of Two Treatments for Acute Rotator Cuff Tendinopathy

The primary objective of this study is to compare the short-term effectiveness (2 and 6 weeks following the start of the rehabilitation program), in terms of symptoms and functional limitations, of a rehabilitation program centered on gradual reloading to a rehabilitation program centered on rest and cryotherapy in individuals with acute rotator cuff tendinopathy. The secondary objective is to explore the effects of these programs on shoulder control (acromiohumeral distance), subacromial structures (supraspinatus tendon thickness) and central pain modulation. The hypothesis is that the rehabilitation program centered on gradual reloading will lead to a faster improvement at week 2 and 6 when compared to the program centered on rest and cryotherapy.

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Key information

Conditions

Acute Rotator Cuff Tendinopathy Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)

Québec, Quebec, Canada

About this study

44 adults (aged between 18 and 65) with acute (< 6 weeks) unilateral symptomatic RC tendinopathy will be recruited.This single-blind (assessor), parallel-group RCT will include three evaluation sessions over 6 weeks (baseline, week 2, week 6) and one meeting with the treating physiotherapist (right after the baseline evaluation). All participants will take part in the baseline evaluation. They will first complete a questionnaire on sociodemographic, symptomatology and comorbidity, as well as self-administered questionnaires that evaluate symptoms and functional limitations (DASH, WORC and BPI). Then, ultrasonographic (US) measurements of AHD and of the supraspinatus tendon and subacromial bursal thickness will be conducted. Thereafter, pain inhibitory control will be assessed using conditioned pain modulation. Finally, the corticospinal excitability of the infraspinatus muscle will be evaluated. Thereafter, participants will be randomly assigned to one of two intervention groups, and then take part in their assigned home program. At week 2 and 6, the self-administered questionnaires will be re-administered (by phone for the week 6 evaluation). A global rating of change question (with % of change since baseline) will also be completed at week 2 and 6. US measurements, conditioned pain modulation and corticospinal excitability will only be revaluated at week 2. To evaluate the effectiveness of blinding, the assessor will complete a question related to his/her opinion of the allocation at week 2. The study will be carried out at the Centre interdisciplinaire de recherche en réadaptation et en intégration sociale (CIRRIS) by two different physiotherapists and in two different laboratories. Ethics approval will be obtained from Institutional Review Board of IRDPQ.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 18 and 65 years old
  • Acute (< 6 weeks) unilateral symptomatic rotator cuff tendinopathy
  • Positive sign in each of the following categories: a) painful arc of movement, b) positive Neer or Kennedy-Hawkins tests, and c) pain on resisted isometric lateral rotation or abduction, or positive Jobe test.

Exclusion criteria

  • Fracture at the symptomatic upper limb;
  • Previous neck or shoulder surgery;
  • Shoulder pain reproduced during active neck movement;
  • Shoulder capsulitis;
  • Clinical signs of a full thickness rotator cuff tear;
  • Rheumatoid, inflammatory, or neurological diseases;
  • Behavioural or cognitive problems.

Treatment and study plan

Gradual reloading

Behavioral

Participants will be asked to perform isometric strengthening exercises in lateral rotation and abduction. Participants will place their affected arm by the side with the elbow gently tucked in close to the body, elbow flexed at 90°, and the thumb pointing upwards. The opposite hand will resist the lateral rotation and abduction. They will be asked to push against the uninvolved hand, building up to sub-maximal pressure (approximately 50% to 75% of the maximum possible force) over five seconds. Then the contraction will be slowly released. A maximum pain level of 5/10 will be accepted when performing the contraction. Elevation movements will also be performed 3 times a day in the frontal, sagittal and scapular plane.

Rest and cryotherapy

Behavioral

Participants will be asked to apply ice wrap on their painful shoulder 3 times a day over the area of pain for 15 minutes. They will be asked to place the ice wrap inside a damp towel cloth (minimise the risk of an ice burn) and secure around the shoulder with a towel. After the 15 minutes, they will be asked to perform gentle, slow, pain free shoulder movements that do not provoke pain. All participants will be provided with a commercial ice wrap. They will also be asked to avoid painful movements, working above shoulder level, repeated or sustained elevation movements and lifting weights.

Primary outcomes

  1. Disabilities of the Arm, Shoulder and Hand questionnaire

    Time frame: Change from baseline at 2 weeks, change from baseline at 6 weeks

    Generic questionnaire assessing any upper limb disorders

Secondary outcomes

  1. Western Ontario Rotator Cuff index

    Time frame: Change from baseline at 2 weeks, change from baseline at 6 weeks

    Questionnaire specific to rotator cuff disorders

  2. Short form of Brief Pain Inventory (questions 1-6 only)

    Time frame: Change from baseline at 2 weeks, change from baseline at 6 weeks

    Pain questionnaire

  3. Acromiohumeral distance in cm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner

    Time frame: Change from baseline at 2 weeks

  4. Supraspinatus tendon thickness in mm using LogiqE9 (GE Healthcare, Milwaukee, WI, USA) ultrasound scanner

    Time frame: Change from baseline at 2 weeks

  5. Percentage change in pain perception using Conditioned Pain Modulation equipment

    Time frame: Change from baseline at 2 weeks

    This measurement represents the effectiveness of descending inhibitory mechanisms

  6. Isometric shoulder external rotation strength

    Time frame: Change from baseline at 2 weeks

    Measured using hand-held digital dynamometer

  7. Isometric shoulder abduction strength

    Time frame: Change from baseline at 2 weeks

    Measured using hand-held digital dynamometer

  8. Shoulder flexion, external rotation at 0 degrees and 90 degrees abduction, internal rotation at 90 degrees abduction

    Time frame: Change from baseline at 2 weeks

    Measured using a digital inclinometer

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Rest or Gradual Reloading in Acute Presentations of Rotator Cuff Tendinopathy - A Randomised Control Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2016
Registry last updated
Feb 27, 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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