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

September 26, 2022 updated by: Neurological Associates of West Los Angeles

Neurogenic Thoracic Outlet Syndrome and Other Forms of Cervical Brachial Syndrome Treated With Plasma Concentrate Enriched for Alpha 2 Macroglobulin

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Neurological Associates of West Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

56 patients (43 women, 13 men) with an age range of 23 to 77 years old who had undergone the outlined procedure were included in this chart review.

Description

Inclusionary Criteria:

  • All patients had daily disabling cervical brachial pain that was continuously present for at least six months.
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: 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.
Baseline
Patient Global Impression of Change Scale (PGIC)
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: 1 month
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.
1 month
Brief Pain Inventory (BPI)
Time Frame: 3 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.
3 months
Brief Pain Inventory (BPI)
Time Frame: 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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event (AE) and Serious Adverse Event (SAE) Reporting
Time Frame: Reported throughout study duration, up to 12 months
Any suspected adverse events possibly related to study procedures were noted. Any serious adverse events were reported immediately. [NONE REPORTED THROUGHOUT STUDY DURATION]
Reported throughout study duration, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurological Associates of West Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33237/1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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