PAIN, INTRACTABLE, ShoulderPRFNCT03251703
Ultrasound-Guided Suprascapular Pulsed Radiofrequency
An observational study of PAIN, INTRACTABLE, Shoulder, run by Sakarya University.
Trial summary
Shoulder pain is the second most common musculoskeletal disease in adults, and it often becomes chronic due to treatment difficulties. Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of chronic shoulder pain due to its long duration of action and non-destructive method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAIN, INTRACTABLE, Shoulder
- What is being tested?
- Ultrasound-Guided Suprascapular Pulsed Radiofrequency .
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Mar 2017
- Phase
- Observational
- 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
- Adult, Older adult
Study population: shoulder pain lasting at least 3 months.
Who may be able to join
- Patients 18 years of age or older who were diagnosed with at least one of the following: adhesive capsulitis of the shoulder (M75.0), rotator cuff syndrome (M75.1), and impingement syndrome of shoulder (M75.4) according to the ICD-10 classifications. These patients lacked pain control despite systemic analgesics and conservative therapy (like physiotherapy) and applied to our pain polyclinics for shoulder pain lasting at least 3 months.
Who cannot join
- Patients with other diseases causing chronic pain, those with neuropathic pain, those who had undergone surgery on the same shoulder, those with an allergy history from local anesthesia, those with abnormal coagulation tests, and those with cardiac pacemakers were excluded from this study.
About this study
Official title: Effects of Ultrasound-Guided Suprascapular Pulsed Radiofrequency Therapy on Chronic Shoulder Pain
Shoulder pain is the second most common musculoskeletal disease in adults, and it often becomes chronic due to treatment difficulties.
Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of chronic shoulder pain due to its long duration of action and non-destructive method.
Read the detailed description
These patients lacked pain control despite systemic analgesics and conservative therapy and applied to our pain polyclinics for shoulder pain lasting at least 3 months.
The ultrasound-guided SSPRF was performed in those patients with a reduction of 50% or more VAS score and those that reported healing in the AROM in the diagnostic SNB.
The resting, motion and sleeping shoulder pain assessments of the patients were done using a visual analog scale (VAS). The shoulder joint function was assessed using the Shoulder Pain and Disability Index (SPADI) questionnaire and the active range of motion (AROM) of the joint was measured using a goniometer In this study, investigators aimed to reveal the effects of ultrasound-guided suprascapular PRF (SSPRF) therapy applied to patients with chronic shoulder pain on both shoulder pain and function.
- Conditions
- PAIN, INTRACTABLE, Shoulder
- Being tested
- Ultrasound-Guided Suprascapular Pulsed Radiofrequency .
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Suprascapular Pulsed Radiofrequency .Procedure or surgery
The ultrasound-Guided Suprascapular Pulsed Radiofrequency was administered under operating room conditions while the patient was monitored in a sitting position.An ultrasound-guided 22 G 5-mm active-tip 100-mm radiofrequency needle (SC-K; Top Neuropole, Tokyo, Japan) was pushed forward towards the suprascapular notch until it passed the transverse scapular ligament using an in-plane approach.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of The Efficacy of Ultrasound-Guided Suprascapular Pulsed Radiofrequency
Retroscopic study
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Jan 2015
- Primary completion1 Jan 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAIN, INTRACTABLE, ShoulderStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serbülent Gökhan BEYAZ, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251703
- Sponsor's protocol ID
- Sakaray University
- Acronym
- PRF
- Status last verified
- Aug 2017
- First submitted
- 13 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-Guided Suprascapular Pulsed Radiofrequency Therapy on Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT03251703
- Acronym / sponsor ID
- PRF / Sakaray University
- Conditions
- PAIN, INTRACTABLE, Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 16 Aug 2017 (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.
Shoulder pain is the second most common musculoskeletal disease in adults, and it often becomes chronic due to treatment difficulties.
Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of chronic shoulder pain due to its long duration of action and non-destructive method.
Detailed description
These patients lacked pain control despite systemic analgesics and conservative therapy and applied to our pain polyclinics for shoulder pain lasting at least 3 months.
The ultrasound-guided SSPRF was performed in those patients with a reduction of 50% or more VAS score and those that reported healing in the AROM in the diagnostic SNB.
The resting, motion and sleeping shoulder pain assessments of the patients were done using a visual analog scale (VAS). The shoulder joint function was assessed using the Shoulder Pain and Disability Index (SPADI) questionnaire and the active range of motion (AROM) of the joint was measured using a goniometer In this study, investigators aimed to reveal the effects of ultrasound-guided suprascapular PRF (SSPRF) therapy applied to patients with chronic shoulder pain on both shoulder pain and function.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- shoulder pain lasting at least 3 months.
Key inclusion criteria (1 listed)
- Patients 18 years of age or older who were diagnosed with at least one of the following: adhesive capsulitis of the shoulder (M75.0), rotator cuff syndrome (M75.1), and impingement syndrome of shoulder (M75.4) according to the ICD-10 classifications. These patients lacked pain control despite systemic analgesics and conservative therapy (like physiotherapy) and applied to our pain polyclinics for shoulder pain lasting at least 3 months.
Key exclusion criteria (1 listed)
- Patients with other diseases causing chronic pain, those with neuropathic pain, those who had undergone surgery on the same shoulder, those with an allergy history from local anesthesia, those with abnormal coagulation tests, and those with cardiac pacemakers were excluded from this 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 |
|---|---|---|
| Ultrasound-Guided Suprascapular Pulsed Radiofrequency .The ultrasound-Guided Suprascapular Pulsed Radiofrequency was administered under operating room conditions while the patient was monitored in a sitting position.An ultrasound-guided 22 G 5-mm active-tip 100-mm radiofrequency needle (SC-K; Top Neuropole, Tokyo, Japan) was pushed forward towards the suprascapular notch until it passed the transverse scapular ligament using an in-plane approach. | Procedure or surgery | – |
Primary outcome
Evaluation of The Efficacy of Ultrasound-Guided Suprascapular Pulsed Radiofrequency
Time frame: 1 years
Retroscopic study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for PAIN, INTRACTABLE, Shoulder
Recruiting
Transcatheter Arterial Embolization Using Nexsphere-F for Chronic Shoulder Pain Refractory to Conservative Treatment
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Active, not recruitingObservational study
Shoulder RFA Pilot Study
Shoulder Pain, Rotator Cuff Injuries
Recruiting
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Shoulder Pain, Tendinopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PAIN, INTRACTABLE, Shoulder, run by Sakarya University.
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: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of The Efficacy of Ultrasound-Guided Suprascapular Pulsed Radiofrequency (time frame: 1 years). 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 16 Aug 2017.