Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Frederiksberg University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Oak Foundation
The Danish Physiotherapy Foundation
Fund for Physiotherapy in Private Practice
Aase and Ejnar Danielsens Foundation
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01506804
First received: May 5, 2011
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Shoulder Bursitis
Other: methylprednisolone

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

Resource links provided by NLM:


Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Pain in the shoulder in both rest and motion (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ultrasound [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical impingement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Shoulder function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506804

Contacts
Contact: Henning Bliddal, Professor +45 38164158 ext 4158 parker@frh.regionh.dk
Contact: Karen Ellegaard, PT, PhD +45 38164158 ext 4158 parker@frh.regionh.dk

Locations
Denmark
The Parker Institute, Frederiksberg Hospital Recruiting
Frederiksberg, Denmark, 2000
Contact: Bliddal, Professor    +45 38164158      
Contact: Ellegaard, PT, PhD    + 45 38164158      
Principal Investigator: Henning Bliddal, Professor         
Sponsors and Collaborators
Frederiksberg University Hospital
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
  More Information

No publications provided

Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01506804     History of Changes
Other Study ID Numbers: H-4-2010-002
Study First Received: May 5, 2011
Last Updated: January 5, 2012
Health Authority: The Capital Region of Denmark ':'

Keywords provided by Frederiksberg University Hospital:
Shoulder
Impingement
Ultrasound
injection of glucocorticosteroid
exercise

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014