Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

NCT ID: NCT01506804

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-04-30

Brief Summary

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Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. Injection in combination with exercise therapy might be a more sufficient therapy than injection alone. The aim of this study is to investigate a combination of steroid injection and a 10 week exercise program. In addition, the study tests the validity of clinical impingement tests using ultrasound verified impingement as gold standard.

Detailed Description

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For many patients unspecific pain and reduced motion in the shoulder is a common complaint. It is believed that the main reason for shoulder pain comes from inflammation of the bursa.

Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. Exercise therapy for the muscles around the shoulder joint is also common treatment for shoulder pain. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. The anti-inflammatory and pain releasing effect of steroid injection in combination with exercise therapy increasing the strength and control of the muscles around the shoulder joint, might be a more sufficient therapy than injection alone. Thus, the aim of this study is to investigate a combination of steroid injection and a 10 week exercise program in patients with a painful shoulder.

Many different clinical tests are used to examine the pathological compression of the bursa during motion in the shoulder joint (impingement). However, it is actually not known if the pain in motion is caused by compression of the bursa. Part of this study therefore is to test the validity of clinical impingement tests using ultrasound verified impingement as gold standard.

Studies comparing injection given guided by ultrasound to blind injections have shown that the ultrasound guided injections are more likely to place the active stuff correctly in the swollen bursa. In this study all injections will be given ultrasound guided. In the ultrasound examination the thickness of the bursa will be measured in all patients in order to investigate if swollenness of the bursa can explained the pain and dysfunction of the shoulder joint

Conditions

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Shoulder Bursitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Training of painful shoulder

Steroid injection X 2 and 10 weeks exercise program of painful shoulder

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type OTHER

Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder

Contralateral training

Steroid injection X 2 and 10 weeks exercise program of asymptomatic shoulder

Group Type PLACEBO_COMPARATOR

methylprednisolone

Intervention Type OTHER

Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder

Interventions

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methylprednisolone

Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pain and reduced motion in the shoulder for more than four weeks
* Ultrasound verified swollenness of the bursa.

Exclusion Criteria

* Bilateral pain in the shoulder joints
* Rupture of the rotator cuff or biceps tendons
* Generalised disease which can explain the shoulder pain
* OA in the shoulder joint
* Diabetes
* Positive compression test of the cervical spine
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oak Foundation

OTHER

Sponsor Role collaborator

The Danish Physiotherapy Foundation

UNKNOWN

Sponsor Role collaborator

Fund for Physiotherapy in Private Practice

UNKNOWN

Sponsor Role collaborator

Aase and Ejnar Danielsens Foundation

OTHER

Sponsor Role collaborator

Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Henning Bliddal

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henning Bliddal, Professor

Role: PRINCIPAL_INVESTIGATOR

The Parker Institute, University of Copenhagen

Locations

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The Parker Institute, Frederiksberg Hospital

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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Ellegaard K, Christensen R, Rosager S, Bartholdy C, Torp-Pedersen S, Bandholm T, Danneskiold-Samsoe B, Bliddal H, Henriksen M. Exercise therapy after ultrasound-guided corticosteroid injections in patients with subacromial pain syndrome: a randomized controlled trial. Arthritis Res Ther. 2016 Jun 4;18(1):129. doi: 10.1186/s13075-016-1002-5.

Reference Type DERIVED
PMID: 27262892 (View on PubMed)

Related Links

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http://www.parkerinst.dk

The Parker Institute, Copenhagen

Other Identifiers

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H-4-2010-002

Identifier Type: -

Identifier Source: org_study_id

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