Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder

NCT01506804 | Completed

• 1 other identifier: H-4-2010-002
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Bursitis

Keywords

Shoulder; Impingement; Ultrasound; injection of glucocorticosteroid; exercise

Outcome Measures

Primary Outcomes (1)

• Pain in the shoulder in both rest and motion (VAS)

  6 months

Secondary Outcomes (4)

• Ultrasound

  6 months

• Strength

  6 months

• Clinical impingement

  6 months

• Shoulder function

  6 months

Study Arms (2)

Training of painful shoulder

EXPERIMENTAL

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

Other: methylprednisolone

Contralateral training

PLACEBO COMPARATOR

Steroid injection X 2 and 10 weeks exercise program of asymptomatic shoulder

Other: methylprednisolone

Interventions

methylprednisolone OTHER

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

Contralateral training; Training of painful shoulder

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain and reduced motion in the shoulder for more than four weeks
• Ultrasound verified swollenness of the bursa.

You may not qualify if:

• 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

Sponsors & Collaborators

• Frederiksberg University Hospital: lead
• Oak Foundation: collaborator
• The Danish Physiotherapy Foundation: collaborator
• Fund for Physiotherapy in Private Practice: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

• Ellegaard K, Christensen R, Rosager S, Bartholdy C, Torp-Pedersen S, Bandholm T, Danneskiold-Samsoe B, Bliddal H, Henriksen M. Exercise therapy after ultrasound-guided corticosteroid injections in patients with subacromial pain syndrome: a randomized controlled trial. Arthritis Res Ther. 2016 Jun 4;18(1):129. doi: 10.1186/s13075-016-1002-5.

  PMID: 27262892 DERIVED

Related Links

• The Parker Institute, Copenhagen

MeSH Terms

Conditions

Motor Activity

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Henning Bliddal, Professor

  The Parker Institute, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: January 10, 2012
• Study Start: November 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

DK (1)