Forms of Cervical Brachial Syndrome Treated With Plasma Concentrate Enriched for A2M
NCT ID: NCT04066933
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
60 participants
OBSERVATIONAL
2018-09-24
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies
NCT02120625
Motor Cortex Stimulation for the Treatment of Chronic Facial, Upper Extremity, and Throat Pain.
NCT02321566
Microwave Diathermy for Treating Nonspecific Chronic Neck Pain
NCT01487122
Intra-articular Corticosteroid Injections to Platelet Rich Plasma (PRP) for Cervical Facetogenic Pain
NCT04392999
Superficial Cervical Plexus Block for IJCL Pain Management
NCT05252832
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Myalgia (MTPS) may be characterized by muscles that are tight and tender to palpation and where there may be radiation of pain down the limb. A twitch may be elicited with stimulation of affected muscle. Numerous treatments for myalgia have been proposed with variable or incomplete success including local anesthetic injections, botulinum chemodenervation and platelet rich plasma injections.
Neuralgic complaints may be caused by chronic compression in the interscalene triangle as in Thoracic Outlet Syndrome (NTOS) and other patients may have injury from sudden stretch, electrocution, inflammatory diseases, penetrating wounds or acute or chronic post-operative conditions. Botulinum chemodenervation and surgical decompression has been applied for treating nerve compression due to Thoracic Outlet Syndrome with partial success. \[9-13\] Chemodenervation tends to be transient in effect and surgery may have significant complications.
Previous reports have demonstrated relatively poor outcomes with targeted treatments when there is a coexistence of conditions characterized by increased sensitivity as in complex regional pain syndrome (CRPS) or fibromyalgia. In the present retrospective review, it was anticipated that patients with CRPS may not respond as well to targeted treatment so that they were evaluated separately from patients with NTOS along.
Because existing therapies for myofascial and neuralgic forms of cervicobrachial pain may have unsatisfactory outcomes, alternative therapies may be considered, particularly, for individuals who have failed to respond. Contemporary conceptualizations of chronic pain mechanisms include the contribution of inflammatory factors. Mindful of these considerations, locally targeted anti-inflammatory administrations may be thought to play a potential role in treatment of cervicobrachial pain.
Alpha 2 macroglobulin is a plasma protein that acts as a molecular trap for inflammatory factors such as tumor necrosis factor, TNF. After plasma is enriched for A2M, it may be injected for treating chronic inflammation. Plasma enriched for A2M may be considered as a possible injectable agent to counteract inflammation that may occur with a cervicobrachial pain syndrome. The present paper reports on an experience using A2M for treating cervicobrachial syndrome which was predominant for either musculotendinous or neuralgic features.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A2M enriched plasma
Plasma enriched for alpha2macroglobulin (A2M-PPP) was produced by a centrifugation and filtration process developed by Cytonics Corporation. Initially, 7 milliliters of Anticoagulant Citrate Dextrose Solution A, ubiquitous surface protein (USP) was drawn into a 60 cc syringe and then an additional 38 cc of autologous blood was drawn up through an antecubital vein. Two syringes were prepared in this manner and then centrifuged at 4000 rpm (1280G) for 4 minutes. The supernatant plasma fraction was then transferred to a roller pump system that circulates the fluid through a proprietary filter having a high molecular weight cutoff designed to trap larger molecules including alpha 2 macroglobulin (720 kDa).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* After examination by one or both of the authors, patients who were diagnosed as having a condition related to musculotendinous pain (MTPS), neuropathic Thoracic Outlet Syndrome (NTOS), or Complex Regional Pain Syndrome (CRPS) qualified for treatment and inclusion in the chart review.
Exclusionary Criteria:
* N/A
* (retrospective analysis of clinical treatment)
23 Years
77 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neurological Associates of West Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sheldon Jordan, MD, FAAN
Role: PRINCIPAL_INVESTIGATOR
Neurological Associates of West Los Angeles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurological Associates of West Los Angeles
Santa Monica, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Waersted M, Hanvold TN, Veiersted KB. Computer work and musculoskeletal disorders of the neck and upper extremity: a systematic review. BMC Musculoskelet Disord. 2010 Apr 29;11:79. doi: 10.1186/1471-2474-11-79.
Pascarelli EF, Hsu YP. Understanding work-related upper extremity disorders: clinical findings in 485 computer users, musicians, and others. J Occup Rehabil. 2001 Mar;11(1):1-21. doi: 10.1023/a:1016647923501.
Simons DG. The nature of myofascial trigger points. Clin J Pain. 1995 Mar;11(1):83-4. No abstract available.
Lavelle ED, Lavelle W, Smith HS. Myofascial trigger points. Med Clin North Am. 2007 Mar;91(2):229-39. doi: 10.1016/j.mcna.2006.12.004.
Cartagena-Sevilla J, Garcia-Fernandez MR, Vicente-Villena JP. Analgesic Effect of Botulinum Toxin A in Myofascial Pain Syndrome Patients Previously Treated with Local Infiltration of Anesthetic and Steroids. J Pain Palliat Care Pharmacother. 2016 Dec;30(4):269-275. doi: 10.1080/15360288.2016.1231742. Epub 2016 Nov 1.
Soares A, Andriolo RB, Atallah AN, da Silva EM. Botulinum toxin for myofascial pain syndromes in adults. Cochrane Database Syst Rev. 2014 Jul 25;2014(7):CD007533. doi: 10.1002/14651858.CD007533.pub3.
Tsikopoulos K, Tsikopoulos I, Simeonidis E, Papathanasiou E, Haidich AB, Anastasopoulos N, Natsis K. The clinical impact of platelet-rich plasma on tendinopathy compared to placebo or dry needling injections: A meta-analysis. Phys Ther Sport. 2016 Jan;17:87-94. doi: 10.1016/j.ptsp.2015.06.003. Epub 2015 Jun 18.
Jordan SE, Ahn SS, Gelabert HA. Combining ultrasonography and electromyography for botulinum chemodenervation treatment of thoracic outlet syndrome: comparison with fluoroscopy and electromyography guidance. Pain Physician. 2007 Jul;10(4):541-6.
Jordan SE, Ahn SS, Gelabert HA. Differentiation of thoracic outlet syndrome from treatment-resistant cervical brachial pain syndromes: development and utilization of a questionnaire, clinical examination and ultrasound evaluation. Pain Physician. 2007 May;10(3):441-52.
Christo PJ, Christo DK, Carinci AJ, Freischlag JA. Single CT-guided chemodenervation of the anterior scalene muscle with botulinum toxin for neurogenic thoracic outlet syndrome. Pain Med. 2010 Apr;11(4):504-11. doi: 10.1111/j.1526-4637.2010.00814.x. Epub 2010 Mar 1.
Torriani M, Gupta R, Donahue DM. Botulinum toxin injection in neurogenic thoracic outlet syndrome: results and experience using a ultrasound-guided approach. Skeletal Radiol. 2010 Oct;39(10):973-80. doi: 10.1007/s00256-010-0897-1. Epub 2010 Feb 26.
Thompson RW, Petrinec D. Surgical treatment of thoracic outlet compression syndromes: diagnostic considerations and transaxillary first rib resection. Ann Vasc Surg. 1997 May;11(3):315-23. doi: 10.1007/s100169900053. No abstract available.
Cuellar JM, Cuellar VG, Scuderi GJ. alpha2-Macroglobulin: Autologous Protease Inhibition Technology. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):909-918. doi: 10.1016/j.pmr.2016.06.008.
Wang S, Wei X, Zhou J, Zhang J, Li K, Chen Q, Terek R, Fleming BC, Goldring MB, Ehrlich MG, Zhang G, Wei L. Identification of alpha2-macroglobulin as a master inhibitor of cartilage-degrading factors that attenuates the progression of posttraumatic osteoarthritis. Arthritis Rheumatol. 2014 Jul;66(7):1843-53. doi: 10.1002/art.38576.
Pasquale, X.M., Jason, M.C., Gaetano, J.S., Intradiscal injection of an Autologous Alpha-2-Macroglobulin (A2M) Concentrate Alleviates Back Pain in FAC-Positive Patients. Ortho and Rheum, 2017. 4(2).
Eltayeb S, Staal JB, Kennes J, Lamberts PH, de Bie RA. Prevalence of complaints of arm, neck and shoulder among computer office workers and psychometric evaluation of a risk factor questionnaire. BMC Musculoskelet Disord. 2007 Jul 14;8:68. doi: 10.1186/1471-2474-8-68.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
33237/1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.