Overview

This trial is active, not recruiting.

Condition shoulder impingement syndrome
Treatments medium-wave 448 khz therapy, ultrasonic therapy, inactive electrotherapy
Sponsor Fundacio Espai Salut
Collaborator Corporación Fisiogestión S.A.
Start date February 2010
End date January 2011
Trial size 92 participants
Trial identifier NCT01073956, FES-2009-01

Summary

The purpose of this study is to determine the efficacy of electrotherapy as a coadjuvant in mobility and exercise treatment in the reduction of pain intensity in subacromial impingement syndrome.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Placebo Comparator)
Inactive electrotherapy is applied to the painful points
inactive electrotherapy
Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.
(Active Comparator)
Ultrasound electrotherapy is applied to the painful points
ultrasonic therapy Ultrasound electrotherapy
Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove
(Active Comparator)
Monopolar radiofrequency electrotherapy is applied to the painful points
medium-wave 448 khz therapy Monopolar radiofrequency
0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove

Primary Outcomes

Measure
Variation of pain intensity
time frame: 12 sessions (1 month)

Secondary Outcomes

Measure
Variation at pain intensity
time frame: 18 sessions (1.5 months)
Variation at pain intensity
time frame: 6 months after intervention

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Men and women over 18 years of age - Shoulder pain secondary to subacromial impingement syndrome - Pain at rest and/or with free movement and/or with movement against resistance with a score on the visual analogue scale of 3 or higher. - Documented X-ray (XR), ultrasound (US) and/or magnetic resonance imaging (MRI) evidence of cuff injury involving oedema, tendonitis, fibrosis or torn tendon. - Potentially available for the next six months. Exclusion Criteria: - Documented US and/or MRI evidence of complete tearing of the cuff and clinical inability to lift the arm (drop arm sign) - Radiological findings of tumour lesions, avascular necrosis, glenoid development defects, acromial bone, severe degenerative signs affecting inter-articular space and fractures - Limited range of passive movement with capsular pattern - Recent history of trauma (contusion, falls or sudden jarring) - Ischaemic cardiopathy in subacute phase - History of more than five infiltrations and/or shoulder surgery - History of rehabilitation treatment for the same reason in the last 12 months - Cognitive deficit, psychiatric alterations or behavioural disorders that might compromise the patient's collaboration - Unsuitable for electrotherapy: pregnancy, epilepsy, pacemaker, osteosynthesis, undergoing treatment with Sintrom - Patients in litigation or in the process of making work-related claims - Failure to understand Spanish

Additional Information

Official title Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial
Principal investigator Conxita Closa, MD
Description Among the different diagnoses covered by the concept of shoulder pain, the most common is subacromial impingement syndrome, which represents 44%-60% of the total.Specific supervised exercises obtain improvements in the range of movement and muscular function by restoring the shoulder's mobility and stability. Physiotherapeutic options include several electrotherapy techniques. Ultrasound is no more beneficial than exercise alone. Likewise, the results of some more recent studies evaluating the application of ultrasound alone versus placebo, showed that ultrasound alone in physiotherapy treatment of shoulder pain is only effective in patients with calcific tendonitis of the shoulder. All the authors, however, suggest that effectiveness can vary, depending on application conditions, dosage and timing. The primary objective of the trial is to analyze the efficacy of electrotherapy treatment (monopolar radiofrequency or ultrasound) coadjuvant to mobility and exercise therapy in the reduction of pain intensity in subacromial impingement syndrome. The secondary objectives of this study are to determine the differences between three intervention groups: monopolar radiofrequency, ultrasound and inactive radiofrequency, in improvement of performance status, quality of life and global impression of improvement.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Fundacio Espai Salut.