AnalgesiaNCT06335472
Three Nerves Versus Suprascapular Nerve Radiofrequency Combined With Hydrodissection in Adhesive Capsulitis
A study testing 3 nerves pulsed radiofrequency with hydrodissection and suprascapular nerve pulsed radiofrequency with hydrodissection in people with Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- 3 nerves pulsed radiofrequency with hydrodissection and suprascapular nerve pulsed radiofrequency with hydrodissection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 5 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult patients aged 30-80 years old 2. Shoulder pain existing for more than one month and reduction range of motion in at least two planes (flexion, abduction, external rotation…)
Who cannot join
- Patient refusal
- malignancy
- Pre-existing neurological deficits or neuropathy
- Significant concomitant shoulder pathology as instability of shoulder joint, labral tears, labral tears, rotator cuff calcific tendinopathy, infectious arthritis, and rheumatological disease of the shoulder
- Previous history of fracture or shoulder dislocation, or cerebrovascular accidents.
- Known allergic history to local anesthetic
- Known contraindications to peripheral nerve block, including local skin infections in the block procedure area, bleeding diathesis, and coagulopathy.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound-guided Effect of Three Nerves Pulsed Radiofrequency Versus Supra-scapular Nerve Pulsed Radiofrequency Both Combined With Hydro-dissection in Reducing the Intensity of Pain in Adhesive Capsulitis
comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.
Read the detailed description
comparison between effect of three nerves suprascapular,axillary,lateral pectoral nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.
- Conditions
- Analgesia
- Being tested
- 3 nerves pulsed radiofrequency with hydrodissection, suprascapular nerve pulsed radiofrequency with hydrodissection
- Keywords
- shoulder pain
- Medical subject headings
- Agnosia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 nerves pulsed radiofrequency with hydrodissectionProcedure or surgery
Also called radiofrequency
Patient will be in a sitting position, targeting the SSN, needle will be pushed towards floor of the suprascapular fossa, SSN is just adjacent to the suprascapular artery.
The axillary nerve, between the deltoid muscle posteriorly, triceps muscle caudally and humerus anteriorly, axillary nerve appears as hyperechoic round in relation to posterior circumflex humeral artery.
Lateral pectoral nerve, middle of coracoid process should be targeted, lie within hyperechoic fascial plane between pectoralis major and pectoralis minor muscle.
hydrodissection, US transducer will be positioned inferior to scapular line , landmarks are contours of glenoid rim and humeral head, needle will be advanced until enter the GHJ capsule.
A solution composed of 3 mL of lidocaine 1%, 3 mL of bupivacaine 0.25%, and 1 mL of dexamethasone 40 mg, followed by infusion of up to 40 mL of normal saline, until capsule is adequately distended and resistance felt
suprascapular nerve pulsed radiofrequency with hydrodissectionProcedure or surgery
The patient will be positioned in a sitting position, PRF needle will be pushed forward towards the floor of the suprascapular fossa the SSN will be visualized just adjacent to the suprascapular artery.
hydrodissection will be done under all aseptic measures ,the US transducer will be positioned just inferior to the scapular line , landmarks are contours of posterior glenoid rim and humeral head, needle will be advanced until the needle tip will enter the GHJ capsule.
A solution composed of 3 mL of lidocaine 1%, 3 mL of bupivacaine 0.25%, and 1 mL of dexamethasone 40 mg, followed by an infusion of up to 40 mL of normal saline , until the capsule is adequately distended and resistance will be felt.
| Study group | Role | What they receive |
|---|---|---|
| three nerves pulsed radiofrequency with hydrodissection | Active comparator | suprascapular nerve ,axillary nerve, lateral pectoral nerve pulsed radiofrequency combined with hydrodissection in adesive capsultis Receives: Procedure: 3 nerves pulsed radiofrequency with hydrodissection |
| suprascapular nerve pulsed radiofrequency with hydrodissection | Active comparator | suprascapular nerve pulsed radiofrequency combined with hydrodissection Receives: Procedure: suprascapular nerve pulsed radiofrequency with hydrodissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score.
effect of pulsed radiofequency in reducing pain in patients suffer from adesive capsulitis
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion3 Feb 2027 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ultrasound-guided effect of three nerves pulsed radiofrequency versus supra-scapular nerve pulsed radiofrequency both combined with hydro-dissection in reducing the intensity of pain in adhesive capsulitis
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Sayed Noaman, Assiut University
- Investigators
- ekram osman, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335472
- Sponsor's protocol ID
- Three nerves radiofrequency
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Publications
3. Ruiz Ibán MA, García Navlet M, Ávila Lafuente J, Alonso Güemes S. Adhesive Capsulitis. In: Textbook of Musculoskeletal Disorders. Springer; 2023. p. 615-26.
3. Ruiz Ibán MA, García Navlet M, Ávila Lafuente J, Alonso Güemes S. Adhesive Capsulitis. In: Textbook of Musculoskeletal Disorders. Springer; 2023. p. 615-26. 4. Schiltz M, Goudman L, Moens M, Jo N, Hatem SM. The diagnostic value of physical examination tests in adhesive capsulitis: a systematic review. Eur J Phys Rehabil Med. 2023;59(6):724 5. Silva R, Pimentel A, Gutierres M. A literature review of the treatment options for Idiopathic Adhesive Capsulitis of the Shoulder. Orthop Spo Med Op Acc J. 2021;4:460-8. 6. . Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, et al. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elb Surg. 2020;29(12):e499-507. 7. Martínez-Gago A, García-Mesa Y, Cuendias P, Martín-Cruces J, Abellán JF, García-Suárez O, et al. SENSORY INNERVATION OF THE HUMAN SHOULDER JOINTS IN HEALTHY AND IN CHRONIC PAIN SHOULDER SYNDROMES. Ann Anatomy-Anatomischer Anzeiger. 2023;152206. 8. Bongiorno G, Bednarova R, Biancuzzi H, Dal Mas F, Rizzardo A, Tomasi A, et al. Pulsed Radiofrequency as a Standalone Treatment for Adhesive Capsulitis. Surgeries. 2023;4(3):335-41. 9. Eckmann MS, Johal J, Bickelhaupt B, McCormick Z, Abdallah RT, Menzies R, et al. Terminal sensory articular nerve radiofrequency ablation for the treatment of chronic intractable shoulder pain: a novel technique and case series. Pain Med. 2020;21(4):868-71. 10. Pushparaj H, Hoydonckx Y, Mittal N, Peng P, Cohen SP, Cao X, et al. A systematic review and meta-analysis of radiofrequency procedures on innervation to the shoulder joint for relieving chronic pain. Eur J Pain. 2021;25(5):986-1011. 11. Küçükbingöz, Çağatay, Bahşi, A., Bayram, T., Marufoglu , F., & Özbek, H. T. (2023). Comparison of the Effectiveness of Pulse Radiofrequency in the Treatment of Suprascapular Nerve in Chronic Shoulder Pain. European Journal of Therapeutics, 29(3), 334-340. 12. Paruthikunnan SM, Shastry PN, Kadavigere R, Pandey V, Karegowda LH. Intra-articular steroid for adhesive capsulitis: does hydrodilatation give any additional benefit? A randomized control trial. Skeletal Radiol. 2020;49:795-803. 13. Chen Y-C, Shen S-H, Chiou H-J, Wan Y-L. Management of Patients with Adhesive Capsulitis via Ultrasound-Guided Hydrodilatation without Concomitant Intra-Articular Lidocaine Infusion: A Single-Center Experience. Life. 2022;12(9):1293. 14. Faul, F., Erdfelder, E., Lang, A.-G. & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191. 15- Mousa, H. (2022): Adhesive Capsulitis Motor and Sensory Stimulation during Radiofrequency Treatment. Saudi J Med. Oct, 2022; 7(10): 549-554. 16- Shafshak TS, Elnemr R. The visual analogue scale versus numerical rating scale in measuring pain severity and predicting disability in low back pain. JCR J Clin Rheumatol. 2021;27(7):282-5.
Leafblad N, Mizels J, Tashjian R, Chalmers P. Adhesive Capsulitis. Phys Med Rehabil Clin N Am. 2023 May;34(2):453-468. doi: 10.1016/j.pmr.2022.12.009. Epub 2023 Feb 28.
PubMed 37003663Sarasua SM, Floyd S, Bridges WC, Pill SG. The epidemiology and etiology of adhesive capsulitis in the U.S. Medicare population. BMC Musculoskelet Disord. 2021 Sep 27;22(1):828. doi: 10.1186/s12891-021-04704-9.
PubMed 34579697
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Effect of Three Nerves Pulsed Radiofrequency Versus Supra-scapular Nerve Pulsed Radiofrequency Both Combined With Hydro-dissection in Reducing the Intensity of Pain in Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06335472
- Acronym / sponsor ID
- Three nerves radiofrequency
- Conditions
- Analgesia
- Keywords
- shoulder pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 28 Mar 2024 (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.
comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.
Detailed description
comparison between effect of three nerves suprascapular,axillary,lateral pectoral nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Ultrasound-guided effect of three nerves pulsed radiofrequency versus supra-scapular nerve pulsed radiofrequency both combined with hydro-dissection in reducing the intensity of pain in adhesive capsulitis
| Arm | Type | Receives |
|---|---|---|
| three nerves pulsed radiofrequency with hydrodissection | Active comparator | Procedure: 3 nerves pulsed radiofrequency with hydrodissectionsuprascapular nerve ,axillary nerve, lateral pectoral nerve pulsed radiofrequency combined with hydrodissection in adesive capsultis |
| suprascapular nerve pulsed radiofrequency with hydrodissection | Active comparator | Procedure: suprascapular nerve pulsed radiofrequency with hydrodissectionsuprascapular nerve pulsed radiofrequency combined with hydrodissection |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult patients aged 30-80 years old 2. Shoulder pain existing for more than one month and reduction range of motion in at least two planes (flexion, abduction, external rotation…)
Key exclusion criteria (8 listed)
- Patient refusal
- malignancy
- Pre-existing neurological deficits or neuropathy
- Significant concomitant shoulder pathology as instability of shoulder joint, labral tears, labral tears, rotator cuff calcific tendinopathy, infectious arthritis, and rheumatological disease of the shoulder
- Previous history of fracture or shoulder dislocation, or cerebrovascular accidents.
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 |
|---|---|---|
| 3 nerves pulsed radiofrequency with hydrodissectionAlso: radiofrequencyPatient will be in a sitting position, targeting the SSN, needle will be pushed towards floor of the suprascapular fossa, SSN is just adjacent to the suprascapular artery. The axillary nerve, between the deltoid muscle posteriorly, triceps muscle caudally and humerus anteriorly, axillary nerve appears as hyperechoic round in relation to posterior circumflex humeral artery. Lateral pectoral nerve, middle of coracoid process should be targeted, lie within hyperechoic fascial plane between pectoralis major and pectoralis minor muscle. hydrodissection, US transducer will be positioned inferior to scapular line , landmarks are contours of glenoid rim and humeral head, needle will be advanced until enter the GHJ capsule. A solution composed of 3 mL of lidocaine 1%, 3 mL of bupivacaine 0.25%, and 1 mL of dexamethasone 40 mg, followed by infusion of up to 40 mL of normal saline, until capsule is adequately distended and resistance felt | Procedure or surgery | three nerves pulsed radiofrequency with hydrodissection |
| suprascapular nerve pulsed radiofrequency with hydrodissectionThe patient will be positioned in a sitting position, PRF needle will be pushed forward towards the floor of the suprascapular fossa the SSN will be visualized just adjacent to the suprascapular artery. hydrodissection will be done under all aseptic measures ,the US transducer will be positioned just inferior to the scapular line , landmarks are contours of posterior glenoid rim and humeral head, needle will be advanced until the needle tip will enter the GHJ capsule. A solution composed of 3 mL of lidocaine 1%, 3 mL of bupivacaine 0.25%, and 1 mL of dexamethasone 40 mg, followed by an infusion of up to 40 mL of normal saline , until the capsule is adequately distended and resistance will be felt. | Procedure or surgery | suprascapular nerve pulsed radiofrequency with hydrodissection |
Primary outcome
The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score.
Time frame: 6 month
effect of pulsed radiofequency in reducing pain in patients suffer from adesive capsulitis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background3. Ruiz Ibán MA, García Navlet M, Ávila Lafuente J, Alonso Güemes S. Adhesive Capsulitis. In: Textbook of Musculoskeletal Disorders. Springer; 2023. p. 615-26.
- Background3. Ruiz Ibán MA, García Navlet M, Ávila Lafuente J, Alonso Güemes S. Adhesive Capsulitis. In: Textbook of Musculoskeletal Disorders. Springer; 2023. p. 615-26. 4. Schiltz M, Goudman L, Moens M, Jo N, Hatem SM. The diagnostic value of physical examination tests in adhesive capsulitis: a systematic review. Eur J Phys Rehabil Med. 2023;59(6):724 5. Silva R, Pimentel A, Gutierres M. A literature review of the treatment options for Idiopathic Adhesive Capsulitis of the Shoulder. Orthop Spo Med Op Acc J. 2021;4:460-8. 6. . Laumonerie P, Dalmas Y, Tibbo ME, Robert S, Faruch M, Chaynes P, et al. Sensory innervation of the human shoulder joint: the three bridges to break. J Shoulder Elb Surg. 2020;29(12):e499-507. 7. Martínez-Gago A, García-Mesa Y, Cuendias P, Martín-Cruces J, Abellán JF, García-Suárez O, et al. SENSORY INNERVATION OF THE HUMAN SHOULDER JOINTS IN HEALTHY AND IN CHRONIC PAIN SHOULDER SYNDROMES. Ann Anatomy-Anatomischer Anzeiger. 2023;152206. 8. Bongiorno G, Bednarova R, Biancuzzi H, Dal Mas F, Rizzardo A, Tomasi A, et al. Pulsed Radiofrequency as a Standalone Treatment for Adhesive Capsulitis. Surgeries. 2023;4(3):335-41. 9. Eckmann MS, Johal J, Bickelhaupt B, McCormick Z, Abdallah RT, Menzies R, et al. Terminal sensory articular nerve radiofrequency ablation for the treatment of chronic intractable shoulder pain: a novel technique and case series. Pain Med. 2020;21(4):868-71. 10. Pushparaj H, Hoydonckx Y, Mittal N, Peng P, Cohen SP, Cao X, et al. A systematic review and meta-analysis of radiofrequency procedures on innervation to the shoulder joint for relieving chronic pain. Eur J Pain. 2021;25(5):986-1011. 11. Küçükbingöz, Çağatay, Bahşi, A., Bayram, T., Marufoglu , F., & Özbek, H. T. (2023). Comparison of the Effectiveness of Pulse Radiofrequency in the Treatment of Suprascapular Nerve in Chronic Shoulder Pain. European Journal of Therapeutics, 29(3), 334-340. 12. Paruthikunnan SM, Shastry PN, Kadavigere R, Pandey V, Karegowda LH. Intra-articular steroid for adhesive capsulitis: does hydrodilatation give any additional benefit? A randomized control trial. Skeletal Radiol. 2020;49:795-803. 13. Chen Y-C, Shen S-H, Chiou H-J, Wan Y-L. Management of Patients with Adhesive Capsulitis via Ultrasound-Guided Hydrodilatation without Concomitant Intra-Articular Lidocaine Infusion: A Single-Center Experience. Life. 2022;12(9):1293. 14. Faul, F., Erdfelder, E., Lang, A.-G. & Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191. 15- Mousa, H. (2022): Adhesive Capsulitis Motor and Sensory Stimulation during Radiofrequency Treatment. Saudi J Med. Oct, 2022; 7(10): 549-554. 16- Shafshak TS, Elnemr R. The visual analogue scale versus numerical rating scale in measuring pain severity and predicting disability in low back pain. JCR J Clin Rheumatol. 2021;27(7):282-5.
- Results publication: PubMed 37003663Leafblad N, Mizels J, Tashjian R, Chalmers P. Adhesive Capsulitis. Phys Med Rehabil Clin N Am. 2023 May;34(2):453-468. doi: 10.1016/j.pmr.2022.12.009. Epub 2023 Feb 28.
- Results publication: PubMed 34579697Sarasua SM, Floyd S, Bridges WC, Pill SG. The epidemiology and etiology of adhesive capsulitis in the U.S. Medicare population. BMC Musculoskelet Disord. 2021 Sep 27;22(1):828. doi: 10.1186/s12891-021-04704-9.
- Individual participant dataSharing planned: Undecided. not yet decided
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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.
ekram osman, professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 nerves pulsed radiofrequency with hydrodissection and suprascapular nerve pulsed radiofrequency with hydrodissection in people with Analgesia, run by Assiut University at 1 site in Egypt.
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 8 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: opening soon, as of the sponsor's last update on 28 Mar 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact safaa noaman, assistant lecturer (01030333468, Safa2gmsy@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The most effective modality on pain management of shoulder adhesive capsulitis using visual analog score. (time frame: 6 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 NCT06335472, which also lists 4 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 28 Mar 2024.