Forms of Cervical Brachial Syndrome Treated With Plasma Concentrate Enriched for A2M

Active, not recruiting

• Conditions: Thoracic Outlet Neurologic Syndrome; Neuralgia; Complex Regional Pain Syndromes

• Registration Number: NCT04066933
• Lead Sponsor: Neurological Associates of West Los Angeles

Brief Summary

Alpha 2 macroglobulin (A2M) 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. This study reports on an experiencing using A2M to treat cervicobrachial syndrome which was predominant for either musculotendinous or neuralgic features.

Detailed Description

Regional pain in the neck, shoulder and arm is a common problem when there is exposure to repetitive work with a prevalence of about fifty percent. In the absence of a widespread pain conditions, and when cervical radiculopathy is ruled out with appropriate imaging, myalgia, tendinopathy or neurogenic sources of pain may predominate in a given case.

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.

Study Timeline

• Study Start: 2018-09-24
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	Baseline	Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points.
Patient Global Impression of Change Scale (PGIC)	3 months	Qualitative assessment of meaningful change obtained by a brief interview to estimate patients' overall perceived benefit of study procedures. The PGIC is structured as a 7-item scale ranging from 1 'very much improved' to 7 'very much worse.' Scores of 1 and 2 reflected notable subjective perception of benefit.

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	6 months	Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.

Trial Locations

Locations (1)

Neurological Associates of West Los Angeles; 🇺🇸 Santa Monica, California, United States