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NCT Number: NCT01506804

Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

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.

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Key information

Conditions

Shoulder Bursitis Behavior Motor Activity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Parker Institute, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone

Other

Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder

Primary outcomes

  1. Pain in the shoulder in both rest and motion (VAS)

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Collaborators

  • Aase and Ejnar Danielsens Foundation
  • Fund for Physiotherapy in Private Practice
  • Oak Foundation
  • The Danish Physiotherapy Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Jan 10, 2012
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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