Shoulder Impingement SyndromeNCT01073956
Efficacy of Electrotherapy in Subacromial Impingement Syndrome
A study testing Medium-wave 448 kHz therapy, Ultrasonic therapy and Inactive electrotherapy in people with Shoulder Impingement Syndrome, run by Fundacio Espai Salut at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Medium-wave 448 kHz therapy, Ultrasonic therapy and Inactive electrotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesSpain
- Study dates
- Feb 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Instituto de Rehabilitación Tres Torres -IR3T
Barcelona, Barcelona, 08017
Centro de Recuperación Funcional (CRF)
Barcelona, Barcelona, 08037
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Medium-wave 448 kHz therapy, Ultrasonic therapy, Inactive electrotherapy
- Keywords
- Subacromial Impingement Syndrome, Shoulder Pain, Physical therapy, Electrotherapy, Ultrasonic therapy, Medium-wave 448 kHz therapy
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium-wave 448 kHz therapyProcedure or surgery
Also called Monopolar radiofrequency
0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove
Ultrasonic therapyProcedure or surgery
Also called Ultrasound electrotherapy
Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove
Inactive electrotherapyProcedure or surgery
Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.
| Study group | Role | What they receive |
|---|---|---|
| Inactive electrotherapy | Placebo comparator | Inactive electrotherapy is applied to the painful points Receives: Procedure: Inactive electrotherapy |
| Ultrasound | Active comparator | Ultrasound electrotherapy is applied to the painful points Receives: Procedure: Ultrasonic therapy |
| Monopolar radiofrequency | Active comparator | Monopolar radiofrequency electrotherapy is applied to the painful points Receives: Procedure: Medium-wave 448 kHz therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of pain intensity
Evaluation after 12 sessions of intervention (1 month)
Measured: 12 sessions (1 month)
Secondary outcomes (2)
Variation at pain intensity
Evaluation at 1.5 months
Measured: 18 sessions (1.5 months)
Variation at pain intensity
Follow-up evaluation
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Espai Salut
- Sponsor type
- University, hospital or other
- Collaborators
- Corporación Fisiogestión S.A., Hospital Clinic of Barcelona, Agència d'Avaluació de Tecnologia i Recerca Mèdiques
- Investigators
- Conxita Closa, MD, Principal investigator, Corporación Fisiogestión S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073956
- Sponsor's protocol ID
- FES-2009-01
- Status last verified
- Jul 2011
- First submitted
- 22 Feb 2010
- Last updated
- 7 Jul 2011
- Results posted
- No
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.
PubMed 12804509
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01073956
- Acronym / sponsor ID
- FES-2009-01
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Subacromial Impingement Syndrome, Shoulder Pain, Physical therapy, Electrotherapy, Ultrasonic therapy, Medium-wave 448 kHz therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Fundacio Espai SalutUniversity, hospital or other
- Collaborators
- Corporación Fisiogestión S.A., Hospital Clinic of Barcelona, Agència d'Avaluació de Tecnologia i Recerca Mèdiques
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactive electrotherapy | Placebo comparator | Procedure: Inactive electrotherapyInactive electrotherapy is applied to the painful points |
| Ultrasound | Active comparator | Procedure: Ultrasonic therapyUltrasound electrotherapy is applied to the painful points |
| Monopolar radiofrequency | Active comparator | Procedure: Medium-wave 448 kHz therapyMonopolar radiofrequency electrotherapy is applied to the painful points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium-wave 448 kHz therapyAlso: Monopolar radiofrequency0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove | Procedure or surgery | Monopolar radiofrequency |
| Ultrasonic therapyAlso: Ultrasound electrotherapyPulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove | Procedure or surgery | Ultrasound |
| Inactive electrotherapyInactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove. | Procedure or surgery | Inactive electrotherapy |
Primary outcome
Variation of pain intensity
Time frame: 12 sessions (1 month)
Evaluation after 12 sessions of intervention (1 month)
2 secondary outcomes
Variation at pain intensity
Time frame: 18 sessions (1.5 months)
Variation at pain intensity
Time frame: 6 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
- Background: PubMed 12804509Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conxita Closa, MD principal investigator
Corporación Fisiogestión S.A.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium-wave 448 kHz therapy, Ultrasonic therapy and Inactive electrotherapy in people with Shoulder Impingement Syndrome, run by Fundacio Espai Salut at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of pain intensity (time frame: 12 sessions (1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2011.