NCT01314196

Brief Summary

The aim of this study was to evaluate the influence of progressive resistance training of the biceps in shoulder rehabilitation in patients with subacromial impingement syndrome (SIS). Method: a randomized controlled clinical trial, with analysis intention-to-treat, approved by the Ethics and Research (1019/08), containing sixty patients of both sexes, SIS, evaluated at the initial time (T0), with 45 days (T45) and 90 days of treatment (T90). We analyzed the pain at rest (VAS), range of shoulder movement, strength, function by The Disabilities of Arm, Shoulder and Hand (DASH) and quality of life by Short Form-36 (SF-36) and Western Ontario Rotator Cuff Index (WORC). They recommended the use of NSAIDs and analgesics in the presence of pain exacerbated, every eight hours. Study groups will perform therapeutic exercises for the shoulder and scapula stabilizers. In the experimental group associate progressive resistance training of the biceps.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
Last Updated

March 14, 2011

Status Verified

December 1, 2010

Enrollment Period

1.8 years

First QC Date

March 9, 2011

Last Update Submit

March 11, 2011

Conditions

Keywords

bicepsresistance trainingrehabilitationimpact syndrome

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pain at rest and quality of life

    Pain assessment will be conducted at rest, using VAS ranging from 0 (no pain) to 10 cm (unbearable pain). The Westein Ontario Rotator Cuff Index (WORC) and Short form-36(SF-36) were the instruments used to assess the quality of life.

    initial time, 45 days and 90 days of treatment

Secondary Outcomes (1)

  • Evaluation range of motion,strength and physical symptoms of the shoulder

    initial time, 45 days and 90 days of treatment

Study Arms (2)

therapeutic exercises

ACTIVE COMPARATOR

therapeutic exercises for the shoulder and scapula stabilizers

Other: therapeutic exercises

progressive resistance training biceps

EXPERIMENTAL

therapeutic exercises for the shoulder and scapula stabilizers and biceps resistance training.

Other: biceps resistance training and therapeutic exercises

Interventions

therapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without producing subacromial impaction.

therapeutic exercises

The biceps resistance training based on calculations of maximum resistance (MR), being conduct in three series 10 reps with 50% of MR in the first series of training and 75% of MR in the second series, with 2 minutes between each and therapeutic exercises for the shoulder and scapula stabilizers.

Also known as: progressive resistance training
progressive resistance training biceps

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with a clinical diagnosis of injury to one or more muscles of the rotator cuff;
  • pain for three months or more, and pain between three and eight, according to visual analog scale (VAS);
  • Hawkins and Neer test positive;
  • aged between 18 and 65

You may not qualify if:

  • fractures of the upper phase of consolidation;
  • patients with total rupture of the long head of the biceps due to the impossibility of getting the muscle resistance training;
  • patients undergoing surgical procedures for shoulder in the three months preceding the study;
  • associated rheumatic diseases because they may interfere in the evaluation of patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 05360-160, Brazil

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • ANA C COÊLHO

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 14, 2011

Study Start

December 1, 2008

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

March 14, 2011

Record last verified: 2010-12

Locations