Clinical trial NCT01506804: Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Bursitis
Keywords: Shoulder
Impingement
Ultrasound
injection of glucocorticosteroid
exercise
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
Collaborators: name: Oak Foundation
name: The Danish Physiotherapy Foundation
name: Fund for Physiotherapy in Private Practice
name: Aase and Ejnar Danielsens Foundation
First posted: 2012-01-10
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain in the shoulder in both rest and motion (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Ultrasound
timeFrame: 6 months
measure: Strength
timeFrame: 6 months
measure: Clinical impingement
timeFrame: 6 months
measure: Shoulder function
timeFrame: 6 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: The Parker Institute, University of Copenhagen
name: Henning Bliddal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.