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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01073956
Other study ID # FES-2009-01
Secondary ID
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


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
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