Back to resultsEfficacy of Electrotherapy in Subacromial Impingement Syndrome
Primary Purpose
Shoulder Impingement Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Medium-wave 448 kHz therapy
Ultrasonic therapy
Inactive electrotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Subacromial Impingement Syndrome, Shoulder Pain, Physical therapy, Electrotherapy, Ultrasonic therapy, Medium-wave 448 kHz therapy
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
Sites / Locations
- Instituto de Rehabilitación Tres Torres -IR3T
- Centro de Recuperación Funcional (CRF)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Inactive electrotherapy
Ultrasound
Monopolar radiofrequency
Arm Description
Inactive electrotherapy is applied to the painful points
Ultrasound electrotherapy is applied to the painful points
Monopolar radiofrequency electrotherapy is applied to the painful points
Outcomes
Primary Outcome Measures
Variation of pain intensity
Evaluation after 12 sessions of intervention (1 month)
Secondary Outcome Measures
Variation at pain intensity
Evaluation at 1.5 months
Variation at pain intensity
Follow-up evaluation
Full Information
NCT ID
NCT01073956
First Posted
February 22, 2010
Last Updated
July 6, 2011
Sponsor
Fundacio Espai Salut
Collaborators
Corporación Fisiogestión S.A., Hospital Clinic of Barcelona, Agència d'Avaluació de Tecnologia i Recerca Mèdiques
1. Study Identification
Unique Protocol Identification Number
NCT01073956
Brief Title
Efficacy of Electrotherapy in Subacromial Impingement Syndrome
Official Title
Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fundacio Espai Salut
Collaborators
Corporación Fisiogestión S.A., Hospital Clinic of Barcelona, Agència d'Avaluació de Tecnologia i Recerca Mèdiques
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
Subacromial Impingement Syndrome, Shoulder Pain, Physical therapy, Electrotherapy, Ultrasonic therapy, Medium-wave 448 kHz therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inactive electrotherapy
Arm Type
Placebo Comparator
Arm Description
Inactive electrotherapy is applied to the painful points
Arm Title
Ultrasound
Arm Type
Active Comparator
Arm Description
Ultrasound electrotherapy is applied to the painful points
Arm Title
Monopolar radiofrequency
Arm Type
Active Comparator
Arm Description
Monopolar radiofrequency electrotherapy is applied to the painful points
Intervention Type
Procedure
Intervention Name(s)
Medium-wave 448 kHz therapy
Other Intervention Name(s)
Monopolar radiofrequency
Intervention Description
0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic therapy
Other Intervention Name(s)
Ultrasound electrotherapy
Intervention Description
Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove
Intervention Type
Procedure
Intervention Name(s)
Inactive electrotherapy
Intervention Description
Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.
Primary Outcome Measure Information:
Title
Variation of pain intensity
Description
Evaluation after 12 sessions of intervention (1 month)
Time Frame
12 sessions (1 month)
Secondary Outcome Measure Information:
Title
Variation at pain intensity
Description
Evaluation at 1.5 months
Time Frame
18 sessions (1.5 months)
Title
Variation at pain intensity
Description
Follow-up evaluation
Time Frame
6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conxita Closa, MD
Organizational Affiliation
Corporación Fisiogestión S.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Rehabilitación Tres Torres -IR3T
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Centro de Recuperación Funcional (CRF)
City
Barcelona
ZIP/Postal Code
08037
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
12804509
Citation
Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.
Results Reference
background
Learn more about this trial
Efficacy of Electrotherapy in Subacromial Impingement Syndrome
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