Chronic Shoulder PainNCT04954391
Pulsed Radiofrequency One or Three Nerves for Chronic Shoulder Pain. A Prospective, Randomized, Double-blind Study
A study testing Pulsed radiofrequency neuromodulation of the suprascapular nerve only and Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves in people with Chronic Shoulder Pain, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
Pulsed radiofrequency (PRF) neuromodulation / or ablation is an interventional pain management method. Clinical use of PRF for shoulder pain management generally focuses on the suprascapular nerve, what is considered a safe and superior to placebo and physiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- Pulsed radiofrequency neuromodulation of the suprascapular nerve only and Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteRussia
- Study dates
- 5 Aug 2021to 30 Apr 2024
- 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
- Chronic pain (existing for more than three months at the time of examination) in the shoulder associated with the following pathology:
- rotator cuff injury
- adhesive capsulitis
- arthrosis of the shoulder joint
- arthrosis of the acromioclavicular joint
- subacromial impingement syndrome
Show all 10Show fewer
- a history of arthroscopic surgery
- Signed informed consent to participate in the study
- Lack of indications for shoulder surgery
- Age> 18 years old 5 The positive effect of the test blockade of the suprascapular, axillary and lateral thoracic nerves with a local anesthetic (reduction of the pain level from the baseline according to NRS by at least 50%)
Who cannot join
- Rotator cuff calcific tendinopathy
- infectious arthritis
- Instability of the shoulder joint
- cervical radiculopathy
- contraindications to local anesthetics
- coagulopathy and anticoagulant therapy
Show all 9Show fewer
- pregnancy
- oncology
- the impossibility of subjective assessment of the level of pain and function of the joint
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Saint Petersburg State University
Saint Petersburg
Konstantin Trukhin, 89213351044, k_truhin_dok@mail.ru
Andrey Povaliy, 89218746479, povandrey23@gmail.com
About this study
Official title: Pulsed Radiofrequency of the Suprascapular, Axillary Nerve and Articular Branch of the Lateral Pectoral Nerve vs Pulsed Radiofrequency of the Suprascapular Nerve Only for Chronic Shoulder Pain. A Prospective Randomized Double-blind Study
Pulsed radiofrequency (PRF) neuromodulation / or ablation is an interventional pain management method. Clinical use of PRF for shoulder pain management generally focuses on the suprascapular nerve, what is considered a safe and superior to placebo and physiotherapy. We study the use of the PRF neuromodulation the suprascapular, axillary, and articular branches of the lateral pectoral nerve, as well as the effectiveness of this combined technique compared to the PRF of the suprascapular nerve alone
Read the detailed description
Background: It's believed that PRf of the suprascapular nerve is a safe and reliable treatment for shoulder pain. But PRF of the suprascapular nerve may be less effective than intra-articular steroid injections (Eyigor et al., 2010). There is also evidence that even test, diagnostic suprascapular nerve blockade in some patients may not give a satisfactory analgesic effect (Sinha et al., 2020). Probably, the unsatisfactory results of PRF suprascapular nerve as a search for a solution force the use of standard thermal RF ablation. (Bone et al., 2013) It is possible to expect a greater clinical effect from the combination of PRF of the three main articular nerves of the suprascapular, axillary and lateral pectoral nerves than from PRF of the suprascapular nerve alone. Nevertheless, having the task of obtaining the maximum effect from PRF, it seems important to maintain a balance between inevitable intervention and excessive intervention, considering that any intervention is associated with the risk of complications.
Methods: The study is planned to include 142 adult patients who are planned to have PRF of the suprascapular nerve due to the presence of chronic shoulder pain.The study is planned as a prospective randomized double-blind controlled trial. According to inclusion / exclusion criteria, written informed consent signing, patients will be randomized in a 1: 1 ratio into two groups: PRF of the suprascapular nerve (n=71) and PRF of the suprascapular, axillary and lateral pectoral nerves (n=71). Patients will be evaluated by a physician 4 weeks and 16 weeks after discharge to receive information on treatment results.
Sample size assessment: To identify differences of 5 points on the SPADI scale at a 5% significance level with 80% power, assuming an expected mean SPADI of 25.5 points and SD - 10.1 according to the study by Korkmaz et al 2010, 64 people will be required for each group. The number 128 was increased to 142 in the sample in order to compensate for observation losses.
- Conditions
- Chronic Shoulder Pain
- Being tested
- Pulsed radiofrequency neuromodulation of the suprascapular nerve only, Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves
- Keywords
- chronic shoulder pain, pulsed radiofrequency, suprascapular nerve, axillary nerve, lateral pectoral nerve, shoulder arthroscopy, rotator cuff injury, adhesive capsulitis, subacromial impingement, glenohumeral arthrosis, acromioclavicular joint
- Medical subject headings
- Rotator Cuff Injuries, Bursitis, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed radiofrequency neuromodulation of the suprascapular nerve onlyProcedure or surgery
Also called PRF one nerve
PRF stimulation of the suprascapular nerve under ultrasound navigation in the notch of the scapula using the Cosman G4 apparatus with the introduction of stimulation: sensory: 50 Hz; 1 ms; up to 0.5 V; motor: 2 Hz; 1 ms; voltage - twice the sensory threshold, but not less than 1V; after introduction of 1 ml of 0.75% ropivacaine, PRF is performed: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec. Before removing the cannula, local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg.
Under the US navigation, an RF cannula will be placed sequentially at the axillary nerve in the quadrilateral foramen and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation and local administration of 0.75% ropivacaine 1 ml PRF session imitation lasting 480 sec will be carried out. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg
Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nervesProcedure or surgery
Also called PRF three nerves
Under ultrasound navigation an RF cannula will be placed sequentially at the suprascapular nerve, at the axillary nerve and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation from RF generator and local administration of 0.75% ropivacaine 1 ml to each nerve, PRF neuromodulation session will be carried out: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec to each nerve. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow to each nerve. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg
| Study group | Role | What they receive |
|---|---|---|
| PRF one nerve | Active comparator | Ultrasound guided PRF neuromodulation of suprascapular nerve and block axillary nerve, and articular branch of the lateral pectoral nerve with ropivacaine and dexamethasone Receives: Procedure: Pulsed radiofrequency neuromodulation of the suprascapular nerve only |
| PRF three nerves | Active comparator | Ultrasound guided PRF neuromodulation of suprascapular, axillary nerves, and articular branch of the lateral pectoral nerve Receives: Procedure: Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPADI value
Scale value Shoulder Pain And Disability Index (SPADI) in points from minimum 0 to maximum 130, where a lower scores means a better outcome
Measured: 16 weeks from the time of the procedure
Secondary outcomes (3)
Constant - Murley Shoulder Score
Scale value Constant - Murley Shoulder Score in points from minimum 0 to maximum 100, where a higher scores means the better of shoulder function.
Measured: 16 weeks from the time of the procedure
Recovery in the functionality of the shoulder - DASH value
Scale value "Disabilities of the Arm, Shoulder and Hand." (DASH) Recovery in the functionality of the shoulder and performing basic activities of daily living from a minimum scale value - 0 (no disability, good functionality) to a maximum - 100 (total disability)
Measured: 16 weeks from the time of the procedure
EQ-5D-5L value
Measuring health-related quality of life according to the EQ-5D-5L questionnaire. Intergroup comparison and deviation from baseline are assessed at 16 weeks from the time of the procedure. Form in the index. Minimum 0 and maximum 1. A higher indicator corresponds to a state of more complete health.
Measured: 16 weeks from the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start5 Aug 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Shoulder PainStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantin Truhin, Saint Petersburg State University, Russia
- Investigators
- Konstantin Trukhin, Principal investigator, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954391
- Sponsor's protocol ID
- 06/21
- Status last verified
- May 2023
- First submitted
- 20 Jun 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korkmaz OK, Capaci K, Eyigor C, Eyigor S. Pulsed radiofrequency versus conventional transcutaneous electrical nerve stimulation in painful shoulder: a prospective, randomized study. Clin Rehabil. 2010 Nov;24(11):1000-8. doi: 10.1177/0269215510371417. Epub 2010 Aug 4.
PubMed 20685721Eyigor C, Eyigor S, Korkmaz OK, Uyar M. Intra-articular corticosteroid injections versus pulsed radiofrequency in painful shoulder: a prospective, randomized, single-blinded study. Clin J Pain. 2010 Jun;26(5):386-92. doi: 10.1097/AJP.0b013e3181cf5981.
PubMed 20473045Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, Bonnevialle N, Mansat P. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elbow Surg. 2020 Dec;29(12):e499-e507. doi: 10.1016/j.jse.2020.07.017. Epub 2020 Jul 23.
PubMed 32712453
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Radiofrequency of the Suprascapular, Axillary Nerve and Articular Branch of the Lateral Pectoral Nerve vs Pulsed Radiofrequency of the Suprascapular Nerve Only for Chronic Shoulder Pain. A Prospective Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT04954391
- Acronym / sponsor ID
- 06/21
- Conditions
- Chronic Shoulder Pain
- Keywords
- chronic shoulder pain, pulsed radiofrequency, suprascapular nerve, axillary nerve, lateral pectoral nerve, shoulder arthroscopy, rotator cuff injury, adhesive capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 8 Jul 2021 (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 (PRF) neuromodulation / or ablation is an interventional pain management method. Clinical use of PRF for shoulder pain management generally focuses on the suprascapular nerve, what is considered a safe and superior to placebo and physiotherapy. We study the use of the PRF neuromodulation the suprascapular, axillary, and articular branches of the lateral pectoral nerve, as well as the effectiveness of this combined technique compared to the PRF of the suprascapular nerve alone
Detailed description
Background: It's believed that PRf of the suprascapular nerve is a safe and reliable treatment for shoulder pain. But PRF of the suprascapular nerve may be less effective than intra-articular steroid injections (Eyigor et al., 2010). There is also evidence that even test, diagnostic suprascapular nerve blockade in some patients may not give a satisfactory analgesic effect (Sinha et al., 2020). Probably, the unsatisfactory results of PRF suprascapular nerve as a search for a solution force the use of standard thermal RF ablation. (Bone et al., 2013) It is possible to expect a greater clinical effect from the combination of PRF of the three main articular nerves of the suprascapular, axillary and lateral pectoral nerves than from PRF of the suprascapular nerve alone. Nevertheless, having the task of obtaining the maximum effect from PRF, it seems important to maintain a balance between inevitable intervention and excessive intervention, considering that any intervention is associated with the risk of complications.
Methods: The study is planned to include 142 adult patients who are planned to have PRF of the suprascapular nerve due to the presence of chronic shoulder pain.The study is planned as a prospective randomized double-blind controlled trial. According to inclusion / exclusion criteria, written informed consent signing, patients will be randomized in a 1: 1 ratio into two groups: PRF of the suprascapular nerve (n=71) and PRF of the suprascapular, axillary and lateral pectoral nerves (n=71). Patients will be evaluated by a physician 4 weeks and 16 weeks after discharge to receive information on treatment results.
Sample size assessment: To identify differences of 5 points on the SPADI scale at a 5% significance level with 80% power, assuming an expected mean SPADI of 25.5 points and SD - 10.1 according to the study by Korkmaz et al 2010, 64 people will be required for each group. The number 128 was increased to 142 in the sample in order to compensate for observation losses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF one nerve | Active comparator | Procedure: Pulsed radiofrequency neuromodulation of the suprascapular nerve onlyUltrasound guided PRF neuromodulation of suprascapular nerve and block axillary nerve, and articular branch of the lateral pectoral nerve with ropivacaine and dexamethasone |
| PRF three nerves | Active comparator | Procedure: Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nervesUltrasound guided PRF neuromodulation of suprascapular, axillary nerves, and articular branch of the lateral pectoral nerve |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Chronic pain (existing for more than three months at the time of examination) in the shoulder associated with the following pathology:
- Signed informed consent to participate in the study
- Lack of indications for shoulder surgery
- Age> 18 years old 5 The positive effect of the test blockade of the suprascapular, axillary and lateral thoracic nerves with a local anesthetic (reduction of the pain level from the baseline according to NRS by at least 50%)
Key exclusion criteria (9 listed)
- Rotator cuff calcific tendinopathy
- infectious arthritis
- Instability of the shoulder joint
- cervical radiculopathy
- contraindications to local anesthetics
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 radiofrequency neuromodulation of the suprascapular nerve onlyAlso: PRF one nervePRF stimulation of the suprascapular nerve under ultrasound navigation in the notch of the scapula using the Cosman G4 apparatus with the introduction of stimulation: sensory: 50 Hz; 1 ms; up to 0.5 V; motor: 2 Hz; 1 ms; voltage - twice the sensory threshold, but not less than 1V; after introduction of 1 ml of 0.75% ropivacaine, PRF is performed: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec. Before removing the cannula, local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg. Under the US navigation, an RF cannula will be placed sequentially at the axillary nerve in the quadrilateral foramen and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation and local administration of 0.75% ropivacaine 1 ml PRF session imitation lasting 480 sec will be carried out. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg | Procedure or surgery | PRF one nerve |
| Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nervesAlso: PRF three nervesUnder ultrasound navigation an RF cannula will be placed sequentially at the suprascapular nerve, at the axillary nerve and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation from RF generator and local administration of 0.75% ropivacaine 1 ml to each nerve, PRF neuromodulation session will be carried out: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec to each nerve. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow to each nerve. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg | Procedure or surgery | PRF three nerves |
Primary outcome
SPADI value
Time frame: 16 weeks from the time of the procedure
Scale value Shoulder Pain And Disability Index (SPADI) in points from minimum 0 to maximum 130, where a lower scores means a better outcome
3 secondary outcomes
Constant - Murley Shoulder Score
Time frame: 16 weeks from the time of the procedure
Recovery in the functionality of the shoulder - DASH value
Time frame: 16 weeks from the time of the procedure
EQ-5D-5L value
Time frame: 16 weeks from the time of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 20685721Korkmaz OK, Capaci K, Eyigor C, Eyigor S. Pulsed radiofrequency versus conventional transcutaneous electrical nerve stimulation in painful shoulder: a prospective, randomized study. Clin Rehabil. 2010 Nov;24(11):1000-8. doi: 10.1177/0269215510371417. Epub 2010 Aug 4.
- Results publication: PubMed 20473045Eyigor C, Eyigor S, Korkmaz OK, Uyar M. Intra-articular corticosteroid injections versus pulsed radiofrequency in painful shoulder: a prospective, randomized, single-blinded study. Clin J Pain. 2010 Jun;26(5):386-92. doi: 10.1097/AJP.0b013e3181cf5981.
- Results publication: PubMed 32712453Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, Bonnevialle N, Mansat P. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elbow Surg. 2020 Dec;29(12):e499-e507. doi: 10.1016/j.jse.2020.07.017. Epub 2020 Jul 23.
- Individual participant dataSharing planned: No
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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.
Konstantin Trukhin principal investigator
Saint Petersburg State University, Russia
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 neuromodulation of the suprascapular nerve only and Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves in people with Chronic Shoulder Pain, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 10 inclusion and 9 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 23 May 2023. 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 Russia. 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 Konstantin Trukhin (89213351044, k_truhin_dok@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPADI value (time frame: 16 weeks from the time of the procedure). 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 NCT04954391, which also lists 3 linked publications.
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 23 May 2023.