Pulsed Radiofrequency of Suprascapular Nerve and Shoulder Joint for Chronic Shoulder Pain

NCT04737993 | Unknown

• 1 other identifier: 1184/13.01/2018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The suprascapular nerve block is frequently used to treat chronic shoulder pain. The nerve blockade provides probably only a short-term relief, and more compelling approaches have been investigated. Pulsed radiofrequency stimulation of suprascapular nerve has been reported as safe and reliable method for pain treatment. However, formal efficacy study for pRF stimulation of the shoulder joint has not been published. Evidence-based validation of a new method is necessary for both scholastic and practical purposes. Methods: This study is a randomized active controlled blind trial. Lidocaine injections alone and pRF stimulation with two different combinations will be performed. Participants will be followed during 6 months, and subjective and objective outcome variables will be recorded. Patients are randomly allocated for suprascapular nerve block (n=50), for suprascapular nerve pRF stimulation (n=50) or for both suprascapular nerve blocks and humeroscapular joint pRF stimulation (n=50). All patients will receive standardized physical therapy at the unit of physical medicine and rehabilitation. Results: Pulsed radiofrequency is thought to be a non-neurolytic neuromodulation method with some effectiveness in relieving of both experimental and clinical neuropathic pain. Our earlier results suggest additional therapeutic benefit obtained when pRF was performed in addition to physiotherapy (TAU). In a review, Chan et al. (2016) concluded that SSNB treatment could be more effective in treating pain in patients with longstanding rheumatoid arthritis when compared to intra-articular injection of corticosteroid. Also short-term pain reduction occurred in patients with chronic rotator cuff lesions. With regard to adhesive capsulitis, SSNB treatment showed a greater effect in relieving pain but on functional outcome, the results were inconclusive. Discussion: In summary, this study investigate effects of pRF for patients with chronic shoulder pain from arthritis, frozen shoulder and/or degenerative shoulder disease. PRF can be performed in an outpatient department and provides the clinician with an alternative or additional approach to oral drug treatment and intra-articular injection. Further, it may prove to be a useful treatment for patients who are unfit or unwilling to consider surgical intervention.

Conditions

Chronic Shoulder Pain

Outcome Measures

Primary Outcomes (3)

• SPADI change is being assessed

  Shoulder Pain and Disability Index change from baseline is being assessed at 2 and 6 months . Disability, pain and total scores 0-100% when 100 is worst.

  0, 2, 6 months

• Active maximal shoulder adduction movement change is being assessed

  Active shoulder joint adduction min 0- max 180. Change from baseline is being assessed at 2 and 6 months

  0,2,6 months

• Active maximal shoulder flexion movement change is being assessed

  Active Shoulder joint flexion min 0 -max 180. Change from baseline is being assessed at 2 and 6 months

  0,2,6 months

Secondary Outcomes (2)

• HQoL 15 d change is being assessed

  0,6 months

• EQ5D change is being aseessed

  0, 6 months

Study Arms (3)

prf shoulder joint

ACTIVE COMPARATOR

pulsed rf stimulation of joint capsel and prf stimlation of subscapular nerve

Drug: licocain; Other: pulsed radiofrequency stimulation

prf subscapular nerve

ACTIVE COMPARATOR

pulsed RF stimulation of subscapular nerve

Drug: licocain; Other: pulsed radiofrequency stimulation

subscapular nerve block

ACTIVE COMPARATOR

lidocain injection of subscapular nerve

Drug: licocain

Interventions

licocain DRUG

pulsed radiofrequency stimulation

Also known as: radiofrequency stimulation

prf shoulder joint; prf subscapular nerve; subscapular nerve block

pulsed radiofrequency stimulation OTHER

pulsed radiofrequency stimulation of joint capsel

prf shoulder joint; prf subscapular nerve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder joint pain \>3 moths

You may not qualify if:

• Other ethiology as cervical root leasion or cancer.-

Sponsors & Collaborators

• Satasairaala: lead

Study Sites (1)

dep of physical medicine and rehabilitation Satasairaala

Pori, 28100, Finland

RECRUITING

Related Publications (34)

• Krismer M, van Tulder M; Low Back Pain Group of the Bone and Joint Health Strategies for Europe Project. Strategies for prevention and management of musculoskeletal conditions. Low back pain (non-specific). Best Pract Res Clin Rheumatol. 2007 Feb;21(1):77-91. doi: 10.1016/j.berh.2006.08.004.

  PMID: 17350545 BACKGROUND

• Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

  PMID: 16550448 BACKGROUND

• Jensen I, Harms-Ringdahl K. Strategies for prevention and management of musculoskeletal conditions. Neck pain. Best Pract Res Clin Rheumatol. 2007 Feb;21(1):93-108. doi: 10.1016/j.berh.2006.10.003.

  PMID: 17350546 BACKGROUND

• Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, Carr A. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology (Oxford). 2006 Feb;45(2):215-21. doi: 10.1093/rheumatology/kei139. Epub 2005 Nov 1.

  PMID: 16263781 BACKGROUND

• Silverstein BA, Viikari-Juntura E, Fan ZJ, Bonauto DK, Bao S, Smith C. Natural course of nontraumatic rotator cuff tendinitis and shoulder symptoms in a working population. Scand J Work Environ Health. 2006 Apr;32(2):99-108. doi: 10.5271/sjweh.985.

  PMID: 16680380 BACKGROUND

• Coghlan JA, Buchbinder R, Green S, Johnston RV, Bell SN. Surgery for rotator cuff disease. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD005619. doi: 10.1002/14651858.CD005619.pub2.

  PMID: 18254085 BACKGROUND

• Saltychev M, Aarimaa V, Virolainen P, Laimi K. Conservative treatment or surgery for shoulder impingement: systematic review and meta-analysis. Disabil Rehabil. 2015;37(1):1-8. doi: 10.3109/09638288.2014.907364. Epub 2014 Apr 2.

  PMID: 24694286 BACKGROUND

• Saltychev M, Virolainen P, Laimi K. Conservative treatment or surgery for shoulder impingement: updated meta-analysis. Disabil Rehabil. 2020 Jun;42(11):1634-1635. doi: 10.1080/09638288.2019.1622796. Epub 2019 May 30. No abstract available.

  PMID: 31144999 BACKGROUND

• van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.

  PMID: 8546527 BACKGROUND

• Cook T, Minns Lowe C, Maybury M, Lewis JS. Are corticosteroid injections more beneficial than anaesthetic injections alone in the management of rotator cuff-related shoulder pain? A systematic review. Br J Sports Med. 2018 Apr;52(8):497-504. doi: 10.1136/bjsports-2016-097444. Epub 2018 Jan 5.

  PMID: 29305377 BACKGROUND

• Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.

  PMID: 12535501 BACKGROUND

• Habib GS, Saliba W, Nashashibi M. Local effects of intra-articular corticosteroids. Clin Rheumatol. 2010 Apr;29(4):347-56. doi: 10.1007/s10067-009-1357-y. Epub 2010 Jan 26.

  PMID: 20101428 BACKGROUND

• Habib GS. Systemic effects of intra-articular corticosteroids. Clin Rheumatol. 2009 Jul;28(7):749-56. doi: 10.1007/s10067-009-1135-x. Epub 2009 Feb 28.

  PMID: 19252817 BACKGROUND

• Muto T, Kokubu T, Mifune Y, Inui A, Harada Y, Yoshifumi, Takase F, Kuroda R, Kurosaka M. Temporary inductions of matrix metalloprotease-3 (MMP-3) expression and cell apoptosis are associated with tendon degeneration or rupture after corticosteroid injection. J Orthop Res. 2014 Oct;32(10):1297-304. doi: 10.1002/jor.22681. Epub 2014 Jul 2.

  PMID: 24985902 BACKGROUND

• Nichols AW. Complications associated with the use of corticosteroids in the treatment of athletic injuries. Clin J Sport Med. 2005 Sep;15(5):370-5. doi: 10.1097/01.jsm.0000179233.17885.18.

  PMID: 16162982 BACKGROUND

• Vorster W, Lange CP, Briet RJ, Labuschagne BC, du Toit DF, Muller CJ, de Beer JF. The sensory branch distribution of the suprascapular nerve: an anatomic study. J Shoulder Elbow Surg. 2008 May-Jun;17(3):500-2. doi: 10.1016/j.jse.2007.10.008. Epub 2008 Feb 11.

  PMID: 18262803 BACKGROUND

• Dean BJ, Gwilym SE, Carr AJ. Why does my shoulder hurt? A review of the neuroanatomical and biochemical basis of shoulder pain. Br J Sports Med. 2013 Nov;47(17):1095-104. doi: 10.1136/bjsports-2012-091492. Epub 2013 Feb 21.

  PMID: 23429268 BACKGROUND

• Borstad J, Woeste C. The role of sensitization in musculoskeletal shoulder pain. Braz J Phys Ther. 2015 Jul-Aug;19(4):251-7. doi: 10.1590/bjpt-rbf.2014.0100. Epub 2015 Aug 7.

  PMID: 26443971 BACKGROUND

• Fernandes MR, Barbosa MA, Sousa AL, Ramos GC. Suprascapular nerve block: important procedure in clinical practice. Rev Bras Anestesiol. 2012 Jan-Feb;62(1):96-104. doi: 10.1016/S0034-7094(12)70108-3.

  PMID: 22248771 BACKGROUND

• Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.

  PMID: 21654552 BACKGROUND

• Chang KV, Hung CY, Wu WT, Han DS, Yang RS, Lin CP. Comparison of the Effectiveness of Suprascapular Nerve Block With Physical Therapy, Placebo, and Intra-Articular Injection in Management of Chronic Shoulder Pain: A Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2016 Aug;97(8):1366-80. doi: 10.1016/j.apmr.2015.11.009. Epub 2015 Dec 14.

  PMID: 26701762 BACKGROUND

• Liu A, Zhang W, Sun M, Ma C, Yan S. Evidence-based Status of Pulsed Radiofrequency Treatment for Patients with Shoulder Pain: A Systematic Review of Randomized Controlled Trials. Pain Pract. 2016 Apr;16(4):518-25. doi: 10.1111/papr.12310. Epub 2015 May 19.

  PMID: 25990576 BACKGROUND

• Ozyuvaci E, Akyol O, Acikgoz A, Leblebici H. Intraarticular pulsed mode radiofrequency lesioning of glenohumeral joint in chronic shoulder pain: 3 cases. Korean J Pain. 2011 Dec;24(4):239-41. doi: 10.3344/kjp.2011.24.4.239. Epub 2011 Nov 30. No abstract available.

  PMID: 22220248 BACKGROUND

• Kukkonen J, Kauko T, Vahlberg T, Joukainen A, Aarimaa V. Investigating minimal clinically important difference for Constant score in patients undergoing rotator cuff surgery. J Shoulder Elbow Surg. 2013 Dec;22(12):1650-5. doi: 10.1016/j.jse.2013.05.002. Epub 2013 Jul 12.

  PMID: 23850308 BACKGROUND

• Gofeld M, Restrepo-Garces CE, Theodore BR, Faclier G. Pulsed radiofrequency of suprascapular nerve for chronic shoulder pain: a randomized double-blind active placebo-controlled study. Pain Pract. 2013 Feb;13(2):96-103. doi: 10.1111/j.1533-2500.2012.00560.x. Epub 2012 May 4.

  PMID: 22554345 BACKGROUND

• Chester R, Shepstone L, Daniell H, Sweeting D, Lewis J, Jerosch-Herold C. Predicting response to physiotherapy treatment for musculoskeletal shoulder pain: a systematic review. BMC Musculoskelet Disord. 2013 Jul 8;14:203. doi: 10.1186/1471-2474-14-203.

  PMID: 23834747 BACKGROUND

• Kuijpers T, van der Windt DAWM, van der Heijden GJMG, Bouter LM. Systematic review of prognostic cohort studies on shoulder disorders. Pain. 2004 Jun;109(3):420-431. doi: 10.1016/j.pain.2004.02.017.

  PMID: 15157703 BACKGROUND

• Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.

  PMID: 11188601 BACKGROUND

• MacDermid JC, Solomon P, Prkachin K. The Shoulder Pain and Disability Index demonstrates factor, construct and longitudinal validity. BMC Musculoskelet Disord. 2006 Feb 10;7:12. doi: 10.1186/1471-2474-7-12.

  PMID: 16472394 BACKGROUND

• Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009 May 15;61(5):623-32. doi: 10.1002/art.24396.

  PMID: 19405008 BACKGROUND

• Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001 Jul;33(5):328-36. doi: 10.3109/07853890109002086.

  PMID: 11491191 BACKGROUND

• Vartiainen P, Heiskanen T, Sintonen H, Roine RP, Kalso E. Health-related quality of life and burden of disease in chronic pain measured with the 15D instrument. Pain. 2016 Oct;157(10):2269-2276. doi: 10.1097/j.pain.0000000000000641.

  PMID: 27355183 BACKGROUND

• Kane TP, Rogers P, Hazelgrove J, Wimsey S, Harper GD. Pulsed radiofrequency applied to the suprascapular nerve in painful cuff tear arthropathy. J Shoulder Elbow Surg. 2008 May-Jun;17(3):436-40. doi: 10.1016/j.jse.2007.10.007. Epub 2008 Mar 7.

  PMID: 18328740 BACKGROUND

• Gurbet A, Turker G, Bozkurt M, Keskin E, Uckunkaya N, Sahin S. [Efficacy of pulsed mode radiofrequency lesioning of the suprascapular nerve in chronic shoulder pain secondary to rotator cuff rupture]. Agri. 2005 Jul;17(3):48-52. Turkish.

  PMID: 16158343 BACKGROUND

Study Officials

• hannu v heikkilä

  Satasairaala

  STUDY DIRECTOR

Central Study Contacts

hannu v heikkilä, MD Phd

CONTACT

+358401493233; hannu.heikkila@satasairaala.fi

aet v ristmägi, MD

CONTACT

+358447073212; aet.ristmagi@satasairaala.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of unit for physical medicine and rehabilitation

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: February 4, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: February 4, 2021

Record last verified: 2021-01

Locations

FI (1)