Center for Global Research Data

Exploration of ailments related to back pain in the medical history data from clinical studies of healthy subjects using formal hypothesis testing and data mining

Lead Investigator: Harry Southworth, Data Clarity Consulting Ltd
Title of Proposal Research:  Exploration of ailments related to back pain in the medical history data from clinical studies of healthy subjects using formal hypothesis testing and data mining
Vivli Data Request: 7598
Funding Source: None
Potential Conflicts of Interest: We see no conflicts of interest. The proposal is to do some basic scientific research. There is no commercial product. For completeness, though, please see below, Dr. Schubiner reports:
Owner, Mind Body Publishing, Inc. Book royalties for Unlearn Your Pain and Unlearn Your Anxiety and Depression.
Co-Owner, Psychophysiologic Press, Inc. Book royalties for Hidden From View.
Co-owner, Freedom From Chronic Pain, Inc. (Australia). Online pain recovery program.
Co-owner, OVID DX. Mobile educational app for diagnosis and treatment of chronic pain.
Consultant, United Health Group Research and Development. Model pain clinic in Las Vegas.
Consultant, Karuna Labs. Online pain recovery program.
Consultant, Curable Health. Online pain recovery program.

 

Summary of the Proposed Research:

According to a 2018 report, 20.4% of adults in the USA had chronic pain in the 2016 study period, and the associated economic cost, including additional health care costs, is estimated to be between $560 and $635 billion per annum.A systematic review published in 2016 estimated the prevalence of chronic pain in UK adults to be as high as 40.3%, and the economic cost of back pain alone is estimated to be £21 billion per annum.

There is a growing literature on overlap between common chronic pain syndromes, in which irritable bowel syndrome and chronic fatigue syndrome are included.

The popular literature on pain syndromes includes many claims that chronic pain is usually psychosomatic in nature: that is, that the mind and body interact to create or worsen the condition. Some go so far as to claim that hay fever, acid reflux, migraine, eczema, tinnitus, frequent urination and other common ailments are also psychosomatic in nature and are related to chronic back pain. That is, the number of conditions claimed to overlap is larger that apparently recognized in the recent scholarly literature and goes considerably beyond just pain syndromes.

Whilst the claim that ailments in such diverse body systems are related and neurological in origin may appear unlikely, a 1998 study found that degree of childhood abuse was predictive of depression, suicidality, heart disease, cancer, lung disease, skeletal fractures and liver disease. It might, therefore, be the case that normal levels of trauma are associated with lesser, but important, morbidities.

The proposed research aims to use existing medical history data from large clinical trials of relatively healthy people to investigate if back pain is related to hay fever, acid reflux, migraine and other conditions, to either negate or effectively prove the relationships.

Should it be found that there are relationships between pain, allergies, gastrointestinal and central nervous system conditions, it cannot be proved that the causes of those conditions are sometimes neurological or the result of normal levels of trauma encountered in life. However, in the absence of an alternative credible overarching explanation that links all those body systems together, neurological origin becomes a strong candidate for patients and physicians to consider.

 

Requested Studies:

Efficacy, Safety, and Immunogenicity Study of GSK Biologicals’ Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Data Contributor: GlaxoSmithKline
Study ID: NCT01165177
Sponsor ID: 110390

Efficacy, Safety and Immunogenicity Study of GSK Biologicals’ Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
Data Contributor: GlaxoSmithKline
Study ID: NCT01165229
Sponsor ID: 113077

Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals’ Influenza Vaccine GSK2186877A in Elderly Subjects
Data Contributor: GlaxoSmithKline
Study ID: NCT00753272
Sponsor ID: 106372

JUPITER – Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
Data Contributor: AstraZeneca
Study ID: NCT00239681