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Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

F

Frederiksberg University Hospital

Status

Completed

Conditions

Shoulder Bursitis

Treatments

Other: methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT01506804
H-4-2010-002

Details and patient eligibility

About

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.

Full 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

Enrollment

99 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

99 participants in 2 patient groups, including a placebo group

Training of painful shoulder
Experimental group
Description:
Steroid injection X 2 and 10 weeks exercise program of painful shoulder
Treatment:
Other: methylprednisolone
Contralateral training
Placebo Comparator group
Description:
Steroid injection X 2 and 10 weeks exercise program of asymptomatic shoulder
Treatment:
Other: methylprednisolone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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