Efficacy of Electrotherapy in Subacromial Impingement Syndrome

NCT ID: NCT01073956

Last Updated: 2011-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-12-31

Brief 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.

Detailed 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.

Conditions

Shoulder Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inactive electrotherapy

Inactive electrotherapy is applied to the painful points

Group Type: PLACEBO_COMPARATOR

Inactive electrotherapy

Intervention Type: PROCEDURE

Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.

Ultrasound

Ultrasound electrotherapy is applied to the painful points

Group Type: ACTIVE_COMPARATOR

Ultrasonic therapy

Intervention Type: PROCEDURE

Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove

Monopolar radiofrequency

Monopolar radiofrequency electrotherapy is applied to the painful points

Group Type: ACTIVE_COMPARATOR

Medium-wave 448 kHz therapy

Intervention Type: PROCEDURE

0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove

Interventions

Medium-wave 448 kHz therapy

0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove

Intervention Type: PROCEDURE

Ultrasonic therapy

Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove

Intervention Type: PROCEDURE

Inactive electrotherapy

Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.

Intervention Type: PROCEDURE

Other Intervention Names

Monopolar radiofrequency; Ultrasound electrotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporación Fisiogestión S.A.

UNKNOWN

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Agència d'Avaluació de Tecnologia i Recerca Mèdiques

OTHER

Sponsor Role: collaborator

Fundacio Espai Salut

OTHER

Sponsor Role: lead

Responsible Party

Corporación Fisiogestión

Principal Investigators

Conxita Closa, MD

Role: PRINCIPAL_INVESTIGATOR

Corporación Fisiogestión S.A.

Locations

Instituto de Rehabilitación Tres Torres -IR3T

Barcelona, Barcelona, Spain

Centro de Recuperación Funcional (CRF)

Barcelona, Barcelona, Spain

Countries

Spain

References

Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.

Reference Type: BACKGROUND

PMID: 12804509 (View on PubMed)

Other Identifiers

FES-2009-01

Identifier Type: -

Identifier Source: org_study_id