Pain SyndromeNCT03498976
RFp on Suprascapular N. Versus RFp on Suprascapular N. and Circumflex in the Treatment of Painful Shoulder
A study testing pulsed radiofrequency in people with Pain Syndrome, run by Hospital Universitario La Fe at 1 site in Spain.
Trial summary
Pulsed radiofrequency produces more lasting pain relief than use of peripheral blocks or analgesic medication in the treatment of chronic pain. We study the use of pulsed radiofrequency on the suprascapular nerve and the Circumflex nerve and the efficacy of the single technique on suprascapular nerve versus the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pain Syndrome
- What is being tested?
- pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 9 Nov 2016to 25 Feb 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Frozen shoulder syndrome (adhesive capsulitis) of more than 3 months evolution Massive rotator cuff tear Partial rupture of some tendon of the rotator cuff Arthrosis of the joint Humeral scapular periarthritis Calcifying tendinitis Bursitis Subacromial syndrome operated by shoulder arthroscopy and persistence of pain over 3 months evolution
Who cannot join
- Rejection of the realization of the technique Anticoagulation or active coagulopathies Infection at the puncture site Psychopathologies or psychiatric problems Judicial litigation at the beginning of the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
José Miguel Esparza Miñana
Valencia, 46013
JOSÉ MIGUEL ESPARZA MIÑANA, 627959771, jesparza@hospitalmanises.es
About this study
Official title: Evaluation of Pulsed Radiofrequency on the Suprascapular Nerve Versus Radiofrequency Pulsed on Suprascapular Nerve and Circumflex in the Treatment of Painful Shoulder
Pulsed radiofrequency produces more lasting pain relief than use of peripheral blocks or analgesic medication in the treatment of chronic pain.
We study the use of pulsed radiofrequency on the suprascapular nerve and the Circumflex nerve and the efficacy of the single technique on suprascapular nerve versus the circumflex and suprascapular combinated technique
Read the detailed description
The painful shoulder is responsible for approximately 16% of all musculoskeletal complaints, constituting one of the most frequent consultations in primary care only behind patients with low back and neck pain.
It has been estimated that 20% of the general population will suffer shoulder pain throughout their lives with a prevalence that can reach up to 50%. It is more prevalent in the elderly with 21% and up to 20% in diabetic patients.
The "painful shoulder syndrome" is a frequent and disabling pathology, of diverse etiology and complex diagnosis, being more common in the female population, and especially from the fifth decade of life in an age range between 45-65 years, although it may manifest itself in other age groups. The prevalence increases with age, some professions and certain sports activities.
Between 70% and 85% of consultations are due to rotator cuff pathology, the most frequent cause of shoulder pain being inflammation of the tendons that form it (supraspinatus, subscapularis, infraspinatus, teres minor and the long portion of the biceps). These are extra-articular muscles, so the clinical picture is called scapulohumeral periarthritis.
Objectives:
Main objective To evaluate the degree of decrease in pain assessment scales (VAS) and decrease in disability scale (SPADI).
Secondary objectives I. Measure the time during which the patient improves pain. II. Evaluate the improvement in the Constant Murley range of motion scale. III. Analyze the recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
IV. Analyze the decrease in the need for analgesic medication (NSAIDs and opiates).
- Assess the appearance of complications related to the performance of pulsed radiofrequency guided with ultrasound.
Study design The patients were evaluated following the usual protocol of the Pain Unit in which all demographic data, age, sex, reason for consultation, personal history, history of pain, exploration and proposed treatment as well as the complementary tests performed were collected. With the clinical judgment of painful shoulder syndrome, if it met at least one inclusion criterion (table), the patient was exposed to the therapeutic possibilities and the possibility of entering the study.
Subsequently, in a period of no more than 30 days, the interventionist technique is performed in the Pain Unit technique room. Finally, a clinical follow-up is carried out in consultation with the Pain Unit at month, three months, six months and nine months from the date of completion of the technique.
- Conditions
- Pain Syndrome
- Being tested
- pulsed radiofrequency
- Keywords
- painful shoulder
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed radiofrequencyProcedure or surgery
Echoguided technic
| Study group | Role | What they receive |
|---|---|---|
| Pulsed radiofrequency on SE nerve | Other | Single technic Receives: Procedure: pulsed radiofrequency |
| Pulsed radiofrequency on SE + CF nerves | Other | Combinated technic Receives: Procedure: pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of decrease in pain assessment scales (VAS)
Change From Baseline on the VAS
Measured: 9 MONTHS
Secondary outcomes (3)
Degree of SPADI scale improvement
Change From Baseline in SPADI scale
Measured: 9 MONTHS
Improvement in the Constant Murley range of motion scale.
Change From Baseline in Constant Murley range of motion scale
Measured: 9 MONTHS
Recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
Change From Baseline in DASH scale
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start9 Nov 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion25 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
- Investigators
- JOSÉ MIGUEL ESPARZA MIÑANA, MD, Principal investigator, Hospital de Manises
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498976
- Sponsor's protocol ID
- ESP-RF
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: WORK IN PROCESS
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulsed Radiofrequency on the Suprascapular Nerve Versus Radiofrequency Pulsed on Suprascapular Nerve and Circumflex in the Treatment of Painful Shoulder
- ClinicalTrials.gov ID
- NCT03498976
- Acronym / sponsor ID
- ESP-RF
- Conditions
- Pain Syndrome
- Keywords
- painful shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 25 Feb 2019 (estimated)
- First posted
- 17 Apr 2018 (actual)
- 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.
Pulsed radiofrequency produces more lasting pain relief than use of peripheral blocks or analgesic medication in the treatment of chronic pain.
We study the use of pulsed radiofrequency on the suprascapular nerve and the Circumflex nerve and the efficacy of the single technique on suprascapular nerve versus the circumflex and suprascapular combinated technique
Detailed description
The painful shoulder is responsible for approximately 16% of all musculoskeletal complaints, constituting one of the most frequent consultations in primary care only behind patients with low back and neck pain.
It has been estimated that 20% of the general population will suffer shoulder pain throughout their lives with a prevalence that can reach up to 50%. It is more prevalent in the elderly with 21% and up to 20% in diabetic patients.
The "painful shoulder syndrome" is a frequent and disabling pathology, of diverse etiology and complex diagnosis, being more common in the female population, and especially from the fifth decade of life in an age range between 45-65 years, although it may manifest itself in other age groups. The prevalence increases with age, some professions and certain sports activities.
Between 70% and 85% of consultations are due to rotator cuff pathology, the most frequent cause of shoulder pain being inflammation of the tendons that form it (supraspinatus, subscapularis, infraspinatus, teres minor and the long portion of the biceps). These are extra-articular muscles, so the clinical picture is called scapulohumeral periarthritis.
Objectives:
Main objective To evaluate the degree of decrease in pain assessment scales (VAS) and decrease in disability scale (SPADI).
Secondary objectives I. Measure the time during which the patient improves pain. II. Evaluate the improvement in the Constant Murley range of motion scale. III. Analyze the recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
IV. Analyze the decrease in the need for analgesic medication (NSAIDs and opiates).
- Assess the appearance of complications related to the performance of pulsed radiofrequency guided with ultrasound.
Study design The patients were evaluated following the usual protocol of the Pain Unit in which all demographic data, age, sex, reason for consultation, personal history, history of pain, exploration and proposed treatment as well as the complementary tests performed were collected. With the clinical judgment of painful shoulder syndrome, if it met at least one inclusion criterion (table), the patient was exposed to the therapeutic possibilities and the possibility of entering the study.
Subsequently, in a period of no more than 30 days, the interventionist technique is performed in the Pain Unit technique room. Finally, a clinical follow-up is carried out in consultation with the Pain Unit at month, three months, six months and nine months from the date of completion of the technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed radiofrequency on SE nerve | Other | Procedure: pulsed radiofrequencySingle technic |
| Pulsed radiofrequency on SE + CF nerves | Other | Procedure: pulsed radiofrequencyCombinated technic |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Frozen shoulder syndrome (adhesive capsulitis) of more than 3 months evolution Massive rotator cuff tear Partial rupture of some tendon of the rotator cuff Arthrosis of the joint Humeral scapular periarthritis Calcifying tendinitis Bursitis Subacromial syndrome operated by shoulder arthroscopy and persistence of pain over 3 months evolution
Key exclusion criteria (1 listed)
- Rejection of the realization of the technique Anticoagulation or active coagulopathies Infection at the puncture site Psychopathologies or psychiatric problems Judicial litigation at the beginning of the study
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 |
|---|---|---|
| pulsed radiofrequencyEchoguided technic | Procedure or surgery | Pulsed radiofrequency on SE + CF nerves, Pulsed radiofrequency on SE nerve |
Primary outcome
Degree of decrease in pain assessment scales (VAS)
Time frame: 9 MONTHS
Change From Baseline on the VAS
3 secondary outcomes
Degree of SPADI scale improvement
Time frame: 9 MONTHS
Improvement in the Constant Murley range of motion scale.
Time frame: 9 MONTHS
Recovery in the functionality of the shoulder and performing basic activities of daily living (DASH scale).
Time frame: 9 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided. WORK IN PROCESS
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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.
JOSÉ MIGUEL ESPARZA MIÑANA, MD principal investigator
Hospital de Manises
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed radiofrequency in people with Pain Syndrome, run by Hospital Universitario La Fe at 1 site 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 1 inclusion and 1 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Contact JOSÉ MIGUEL ESPARZA MIÑANA, MD (627959771, jesparza@hospitalmanises.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of decrease in pain assessment scales (VAS) (time frame: 9 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2018.