Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

Shoulder Bursitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506804
• Other study ID #: H-4-2010-002
• Status: Completed
• Phase: N/A
• First received: May 5, 2011
• Last updated: August 9, 2016
• Start date: November 2010
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Capital Region of Denmark ':'
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis
• Shoulder Bursitis

Intervention

Other:
• methylprednisolone
Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Frederiksberg

Sponsors (5)

Lead Sponsor	Collaborator
Frederiksberg University Hospital	Aase and Ejnar Danielsens Foundation, Fund for Physiotherapy in Private Practice, Oak Foundation, The Danish Physiotherapy Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain in the shoulder in both rest and motion (VAS)		6 months	No
Secondary	Ultrasound		6 months	No
Secondary	Strength		6 months	No
Secondary	Clinical impingement		6 months	No
Secondary	Shoulder function		6 months	No

External Links

•   The Parker Institute, Copenhagen