Efficacy of Electrotherapy in Subacromial Impingement Syndrome

Shoulder Impingement Syndrome Clinical Trial

Official title:

Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01073956
• Other study ID #: FES-2009-01
• Status: Active, not recruiting
• Phase: N/A
• First received: February 22, 2010
• Last updated: July 6, 2011
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Fundacio Espai Salut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

Procedure:
• Medium-wave 448 kHz therapy
0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove
• Ultrasonic therapy
Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove
• Inactive electrotherapy
Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.

Locations

Country	Name	City	State
Spain	Centro de Recuperación Funcional (CRF)	Barcelona
Spain	Instituto de Rehabilitación Tres Torres -IR3T	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Fundacio Espai Salut	Agència d'Avaluació de Tecnologia i Recerca Mèdiques, Corporación Fisiogestión S.A., Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;(2):CD004258. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of pain intensity	Evaluation after 12 sessions of intervention (1 month)	12 sessions (1 month)	Yes
Secondary	Variation at pain intensity	Evaluation at 1.5 months	18 sessions (1.5 months)	Yes
Secondary	Variation at pain intensity	Follow-up evaluation	6 months after intervention	Yes