NCT01257113

Brief Summary

The purpose of this study is to determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with shoulder pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

December 8, 2010

Last Update Submit

November 20, 2019

Conditions

Shoulder Impingement Syndrome

Keywords

shoulder painshoulder impingementrotatorcuff pathologysupervised exercisehomebased exercise

Outcome Measures

Primary Outcomes (3)

  • Pain and function 1

    Shoulder Pain and Disability Index

    Baseline

  • Pain and function 2

    Shoulder Pain and Disability Index

    At 6 weeks

  • Pain and function 3

    Shoulder Pain and Disability Index

    At 6 months

Secondary Outcomes (13)

  • Fear avoidance 1

    Baseline

  • Fear avoidance 2

    At 6 weeks

  • Quality of life 1

    Baseline

  • Quality of life 2

    At 6 weeks

  • Pain the last week

    Baseline and once a week for 6 weeks

  • +8 more secondary outcomes

Study Arms (2)

supervised exercise

EXPERIMENTAL

The group gets 10 supervised exerciseclasses at the physiotherapy clinic in addition to homebased exercises

Other: supervised exercise

homebased exercises

EXPERIMENTAL

The group gets 1 supervised exerciseclass before they do all their exercises at home

Other: homebased exercises

Interventions

supervised exerciseOTHER

This group will receive 10 classes of supervised exercise in the 6 weeks intervention. In this classes the patients will be with a physiotherapist that will adjust their home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises

supervised exercise
homebased exercisesOTHER

This group will receive 1 class of supervised exercise at the beginning of the 6 weeks intervention. In this class the patients will be with a physiotherapist that will put together a home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises

homebased exercises

Eligibility Criteria

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

You may qualify if:

  • Pain in one shoulder
  • Had the condition for more than 12 weeks
  • Pain at abduction (must be present in some part between 60 and 120 degrees)
  • Pain/ weakness in isometric external rotation
  • Positive Hawkins test

You may not qualify if:

  • Instability
  • Labral pathology
  • Acromioclavicular joint (AC-joint) pathology
  • Complete rupture in the rotatorcuff
  • Glenohumeral osteoarthritis
  • Previously operated on current shoulder
  • The pain comes from neck pathology
  • Rheumatoid arthritis or other serious physical or mental illness
  • Lack of Norwegian language
  • Unable to start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tverrfaglig Poliklinikk, rygg-nakke-skulder. Fys.Med. og rehab., St.Olavs Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.

    PMID: 26093810RESULT

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ottar Vasseljen, Dr.Philos

    Norwegian University of Science and Technology

    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

December 8, 2010

First Posted

December 9, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

NO(1)