Efficacy of Electrotherapy in Subacromial Impingement Syndrome
|ClinicalTrials.gov Identifier: NCT01073956|
Recruitment Status : Unknown
Verified July 2011 by Fundacio Espai Salut.
Recruitment status was: Active, not recruiting
First Posted : February 23, 2010
Last Update Posted : July 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Impingement Syndrome||Procedure: Medium-wave 448 kHz therapy Procedure: Ultrasonic therapy Procedure: Inactive electrotherapy||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||December 2011|
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 Name: 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 Name: Monopolar radiofrequency
- Variation of pain intensity [ Time Frame: 12 sessions (1 month) ]Evaluation after 12 sessions of intervention (1 month)
- Variation at pain intensity [ Time Frame: 18 sessions (1.5 months) ]Evaluation at 1.5 months
- Variation at pain intensity [ Time Frame: 6 months after intervention ]Follow-up evaluation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073956
|Instituto de Rehabilitación Tres Torres -IR3T|
|Barcelona, Spain, 08017|
|Centro de Recuperación Funcional (CRF)|
|Barcelona, Spain, 08037|
|Principal Investigator:||Conxita Closa, MD||Corporación Fisiogestión S.A.|