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Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

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ClinicalTrials.gov Identifier: NCT01506804
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : August 10, 2016
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

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.

Condition or disease Intervention/treatment
Shoulder Bursitis 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  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2010
Primary Completion Date : December 2015
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Pain in the shoulder in both rest and motion (VAS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Ultrasound [ Time Frame: 6 months ]
  2. Strength [ Time Frame: 6 months ]
  3. Clinical impingement [ Time Frame: 6 months ]
  4. Shoulder function [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506804


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01506804     History of Changes
Other Study ID Numbers: H-4-2010-002
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

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

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