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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

JOSÉ MIGUEL ESPARZA MIÑANA, MD contact

627959771

jesparza@hospitalmanises.es

Spain1 site, 1 recruiting
  • José Miguel Esparza Miñana

    Valencia, 46013

    JOSÉ MIGUEL ESPARZA MIÑANA, 627959771, jesparza@hospitalmanises.es

    Recruiting

Other trials in Spain

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).

  1. 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 groups in NCT03498976
Study groupRoleWhat they receive
Pulsed radiofrequency on SE nerveOtherSingle technic
Receives: Procedure: pulsed radiofrequency
Pulsed radiofrequency on SE + CF nervesOtherCombinated technic
Receives: Procedure: pulsed radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Degree of decrease in pain assessment scales (VAS)

    Change From Baseline on the VAS

    Measured: 9 MONTHS

Secondary outcomes (3)
  1. Degree of SPADI scale improvement

    Change From Baseline in SPADI scale

    Measured: 9 MONTHS

  2. Improvement in the Constant Murley range of motion scale.

    Change From Baseline in Constant Murley range of motion scale

    Measured: 9 MONTHS

  3. 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.

  1. First posted17 Apr 2018
  2. Study start9 Nov 2016
  3. Primary completion31 Dec 2018 (estimated)
  4. Study completion25 Feb 2019 (estimated)

Resources

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)
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

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.

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