Effects of Overload Progressive in the Treatment of Shoulder

NCT02870257 | Completed DMC

• 1 other identifier: 1.487.198
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Shoulder Impingement Syndrome

Outcome Measures

Primary Outcomes (3)

• Change in Numeric pain rating scale (0-10)

  baseline, 10 weeks, 3 months and 6 months

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

  baseline, 10 weeks, 3 months and 6 months

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

  baseline, 10 weeks, 3 months and 6 months

Secondary Outcomes (5)

• Disabilities

  Change from baseline at 10 weeks

• Quality of life

  Change from baseline at 10 weeks

• Muscle Strength

  Change from baseline at 10 weeks

• Scapular kinematic

  Change from baseline at 10 weeks

• Global impression of recovery

  Change from baseline at 10 weeks, 3 months and 6 months

Study Arms (2)

Progressive overload strengthening group

EXPERIMENTAL

Strengthening protocol with progressive load Strengthening muscle exercises for the shoulder and scapular with progressive increase of load during 10 weeks (20 sessions)

Other: Strengthening protocol with progressive load

Strengthening group

ACTIVE COMPARATOR

Strengthening protocol without progressive load Strengthening muscle exercises for the shoulder and scapular without increase of load (minimal load) during 10 weeks (20 sessions)

Other: Strengthening protocol without progressive load

Interventions

Strengthening protocol with progressive load OTHER

Strengthening protocol for scapular and shoulder muscles

Progressive overload strengthening group

Strengthening protocol without progressive load OTHER

Strengthening protocol for scapular and shoulder muscles

Strengthening group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

UNINOVE

São Paulo, São Paulo, 01504001, Brazil

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• André S Bley, Msd

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 17, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

BR (1)