Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder
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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 |
- Pain in the shoulder in both rest and motion (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| 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 |
| 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 | |
| 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:
|
Bursitis Joint Diseases Musculoskeletal Diseases 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 Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013