Efficacy of Electrotherapy in Subacromial Impingement Syndrome

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

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Procedure: Inactive electrotherapy; Procedure: Ultrasonic therapy; Procedure: Medium-wave 448 kHz therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08017
    • Instituto de Rehabilitación Tres Torres -IR3T
  • Barcelona, Spain, 08037
    • Centro de Recuperación Funcional (CRF)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Inactive electrotherapy; Inactive electrotherapy is applied to the painful points	Procedure: Inactive electrotherapy; Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.
Active Comparator: Ultrasound; Ultrasound electrotherapy is applied to the painful points	Procedure: Ultrasonic therapy; Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove; Other Names: Ultrasound electrotherapy
Active Comparator: Monopolar radiofrequency; Monopolar radiofrequency electrotherapy is applied to the painful points	Procedure: Medium-wave 448 kHz therapy; 0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove; Other Names: Monopolar radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of pain intensity	Evaluation after 12 sessions of intervention (1 month)	12 sessions (1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation at pain intensity	Evaluation at 1.5 months	18 sessions (1.5 months)
Variation at pain intensity	Follow-up evaluation	6 months after intervention

Collaborators and Investigators

• Sponsor: Fundacio Espai Salut
• Collaborators: Hospital Clinic of Barcelona; Corporación Fisiogestión S.A.; Agència d'Avaluació de Tecnologia i Recerca Mèdiques
• Investigators: Principal Investigator: Conxita Closa, MD, Corporación Fisiogestión S.A.

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 7, 2011
• Last Update Submitted That Met QC Criteria: July 6, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Subacromial Impingement Syndrome; Shoulder Pain; Physical therapy; Electrotherapy; Ultrasonic therapy; Medium-wave 448 kHz therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: FES-2009-01