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Completed

NCT Number: NCT02870257

Effects of Overload Progressive in the Treatment of Shoulder

Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. The primary outcomes measures will be pain, function, quality of life, global impression of recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). The secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these data, change will be measure from baseline at 10 weeks (after 20 sessions).

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Key information

Conditions

Shoulder Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNINOVE

São Paulo, 01504001, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • People with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis
  • shoulder pain for more than 4 months, at least 4 points of pain in 0-10 NPRS
  • at least 130° shoulder active elevation
  • 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, Neer, empty can (Jobe) and Hawkins-Kennedy
  • positive dynamic scapular dyskinesis in clinical observation

Exclusion criteria

  • Referred pain from vertebral spine
  • previous shoulder, elbow or neck surgery
  • complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness)
  • neoplastic or neurological disorders
  • previous fracture or dislocation injury (shoulder, humerus, clavicle)
  • adhesive capsulitis signs
  • inflammatory diseases
  • specific treatment for the shoulder in the previous four months (injection, physiotherapy)
  • using drugs in the previous week
  • inability to understand portuguese language

Treatment and study plan

Strengthening protocol with progressive load

Other

Strengthening protocol for scapular and shoulder muscles

Strengthening protocol without progressive load

Other

Strengthening protocol for scapular and shoulder muscles

Primary outcomes

  1. Change in Numeric pain rating scale (0-10)

    Time frame: baseline, 10 weeks, 3 months and 6 months

  2. Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)

    Time frame: baseline, 10 weeks, 3 months and 6 months

  3. Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)

    Time frame: baseline, 10 weeks, 3 months and 6 months

Secondary outcomes

  1. Disabilities

    Time frame: Change from baseline at 10 weeks

    DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire (0-100)

  2. Quality of life

    Time frame: Change from baseline at 10 weeks

    WORC (The Western Ontario Rotator Cuff Index) Questionnaire (0-100)

  3. Muscle Strength

    Time frame: Change from baseline at 10 weeks

    Shoulder internal rotation, external rotation, adduction and abduction muscles measured by handheld dynamometer

  4. Scapular kinematic

    Time frame: Change from baseline at 10 weeks

    3D data of scapula at 30, 60, 90 and 120° of shoulder abduction

  5. Global impression of recovery

    Time frame: Change from baseline at 10 weeks, 3 months and 6 months

    GPE (global perceived effect) scale (-5 to +5)

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Oct 11, 2017

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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