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Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

The Efficacy of Exercise Therapy Followed by Ultrasound Guided Injection in Patients With a Painful Shoulder - a Randomised Controlled Study With Blinded Observer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01506804
Enrollment
99
Registered
2012-01-10
Start date
2010-11-30
Completion date
2016-04-30
Last updated
2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Bursitis

Keywords

Shoulder, Impingement, Ultrasound, injection of glucocorticosteroid, exercise

Brief summary

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

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

Interventions

OTHERmethylprednisolone

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

Sponsors

Oak Foundation
CollaboratorOTHER
The Danish Physiotherapy Foundation
CollaboratorUNKNOWN
Fund for Physiotherapy in Private Practice
CollaboratorUNKNOWN
Aase and Ejnar Danielsens Foundation
CollaboratorOTHER
Frederiksberg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain in the shoulder in both rest and motion (VAS)6 months

Secondary

MeasureTime frame
Ultrasound6 months
Strength6 months
Clinical impingement6 months
Shoulder function6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026