NCT01508715

Brief Summary

The purpose of this study is to compare two different physical therapy exercise programs in persons who have shoulder pain in order to determine if they have a different affect on pain level and ability to use the injured shoulder after treatment. Both exercise groups will attend physical therapy for an hour,two to three times a week, for eight weeks. The first two weeks of therapy sessions will involve learning the exercises and testing to determine what weight to use during exercises. One group will perform a traditional therapy exercise program for shoulders using hand weights. The other group will perform a version of the same shoulder exercises but with a different exercise technique. Exercises in both programs are part of the standard of care for shoulder impingement in physical therapy but one program concentrates on the lowering portion of the exercise (eccentrics) while the other emphasizes the lifting portion of the exercise (concentrics). Both groups will perform the same warm-up, stretching, and cool-down exercises. Participants will also be required to perform a daily home exercise program of stretches and range of motion that will take about 20 minutes to complete. Exercise testing will determine the hand weight resistance used by each person during their therapy sessions and re-testing will occur every two weeks to determine any changes in the weight used for the exercises to keep them challenging. Pain level, ability to use the injured arm for daily activities, strength, and amount of movement in the shoulder, will be measured at the start of physical therapy and after five and eight weeks (end of study) of the exercise treatments. A concurrent study investigating the reliability of the shoulder motion and strength measurements used in the larger study will also be performed. Research hypotheses:

  1. 1.Adults with shoulder pain who complete the eccentric progressive resistive exercise intervention will demonstrate significantly greater improvements in the outcome measures at three weeks, earlier in the intervention, than the concentric progressive resistive exercise intervention group.
  2. 2.Adults with shoulder pain who perform progressive resistive exercise interventions, regardless of contraction type, will demonstrate significant improvement in the shoulder outcome measures at three and six weeks of intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

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

First Submitted

Initial submission to the registry

January 4, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

January 4, 2012

Last Update Submit

April 15, 2014

Conditions

Keywords

subacromialrotator cuffimpingementphysical therapyeccentric exerciseconcentric exercise

Outcome Measures

Primary Outcomes (1)

  • Change in Shoulder function

    Measured by change in numeric pain rating scale (NPRS)score for shoulder pain, change in disabilities of the arm, shoulder, and hand (DASH) self-report of function score, change in shoulder abduction and external rotation strength assessed with a hand-held dynamometer, and change in shoulder flexion and scapular plane elevation pain-free range of motion assessed with a digital inclinometer.

    baseline, after 3 weeks and 6 weeks of intervention

Secondary Outcomes (1)

  • Intratester reliability

    over course of study

Study Arms (2)

Concentric exercise group

ACTIVE COMPARATOR

The participants in this group will perform the intervention exercises by actively completing the lifting portion of the resistive shoulder exercises. The physical therapist will then perform the lowering portion of the exercise for the participant.

Other: Shoulder resistive exercise

Eccentric exercise group

EXPERIMENTAL

The participants in this group will actively perform the lowering portion of the resistive shoulder exercises in the intervention. The physical therapist will perform the lifting portion of the exercise for the participant.

Other: Shoulder resistive exercise

Interventions

Both groups will perform the seated "full can", sidelying internal rotation (IR), sidelying external rotation (ER) with towel roll, supine protraction at 120° of flexion, sidelying horizontal abduction, sidelying abduction, and seated pulley extension using resistance weights in the participant's pain-free shoulder motion. One group will complete only the eccentric portion of the exercise actively, the other will complete only the concentric portion actively. The treating physical therapist will reposition the weights to avoid active resistance occuring in the opposite direction of the desired intervention. Both groups will use 70% of their predicted one repetition maximum (1RM), progressing to 80% with 1RM reassessed and training weight adjusted every two weeks.

Concentric exercise groupEccentric exercise group

Eligibility Criteria

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

You may qualify if:

  • years of age and older
  • Present with clinical signs of subacromial impingement syndrome
  • Have not yet initiated physical or occupational therapy treatment

You may not qualify if:

  • Previous shoulder, cervical, or thoracic surgery.
  • History of shoulder fracture, dislocation, labral tear, or full thickness rotator cuff tear
  • Treatment for neoplasm in the last year
  • Rheumatic disease
  • Adhesive capsulitis
  • Shoulder pain currently rated greater than or equal to 8/10 on the NPRS
  • Cardiac, neurological, or musculoskeletal condition that precludes ability to perform upper extremity resisted exercise
  • Pregnancy
  • inability to understand spoken or written English
  • Inability to arrange transport to evaluation or treatment sessions or not planning to stay in the area long enough to complete study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Health Resources, Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Christiana L Blume, PT, PhD, OCS

    Texas Woman's University, Texas Health Resources, Dallas

    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
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 12, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations