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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Bursitis
• Intervention / Treatment: Other: methylprednisolone

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

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • The Parker Institute, Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training of painful shoulder; Steroid injection X 2 and 10 weeks exercise program of painful shoulder	Other: methylprednisolone; Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder
Placebo Comparator: Contralateral training; Steroid injection X 2 and 10 weeks exercise program of asymptomatic shoulder	Other: methylprednisolone; Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain in the shoulder in both rest and motion (VAS)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Ultrasound	6 months
Strength	6 months
Clinical impingement	6 months
Shoulder function	6 months

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Collaborators: Oak Foundation; The Danish Physiotherapy Foundation; Fund for Physiotherapy in Private Practice; Aase and Ejnar Danielsens Foundation
• Investigators: Principal Investigator: Henning Bliddal, Professor, The Parker Institute, University of Copenhagen

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Parker Institute, Copenhagen

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasound; exercise; Shoulder; Impingement; injection of glucocorticosteroid
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: H-4-2010-002