The Arachnoiditis Patient Registry is an online registry for patients with Arachnoiditis. It will be hosted by the National Organization for Rare Disorders (NORD); an independent non-profit patient advocacy organization dedicated to individuals with rare diseases and the organizations who serve them and as such is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services. The registry will collect information from participants, (or their authorized respondents, heretofore referred to collectively as “participants”), who are affected by Arachnoiditis.
The arachnoid matter is one of three layers (the middle layer) comprising the meninges of the brain and the membranes surrounding the spinal cord. The cerebrospinal fluid, which functions in supporting/protecting the brain as well as circulating important nutrients and removing wastes, is located in the subarachnoid space. Arachnoid inflammation is a precursor for scar tissue synthesis (fibrosis) and spinal nerve adhesion. Arachnoiditis is a rare disorder involving inflammation of the arachnoid matter that is characterized by intense, chronic pain localized throughout the body. The causes and symptoms of Arachnoiditis vary; therefore, the disorder presents with a wide array of clinical features. Chronic pain is commonly experienced in the lumbar region (lower back), perineum, and lower extremities (legs and feet). Additional symptoms include, but are not limited to: joint pain (arthralgia), proprioceptive inhibition, tingling or burning sensations (paresthesia), epithelial sensations described as bugs crawling, muscle cramps, headaches, bowel and/or sexual dysfunction, and depression. Etiologies (causes) of Arachnoiditis include mechanical injuries, spinal cord trauma, epidural disc prolapse, spinal tap(s), multiple steroid epidural injections, intrathecal injections, blood in the cerebrospinal fluid, myelogram dye injection into the spinal cord, and infections (bacterial, viral or fungal).
Arachnoiditis gained recognition as its own disease state in 1909 courtesy of Sir Victor Horsley. Also commonly referred to as chronic adhesive Arachnoiditis, Arachnoiditis has been clinically documented less than 1000 times within the past fifty years (as of 2003). Soon after Horsley's discovery in 1909, a pattern of swelling inquiry, debate, and concern about spinal epidurals began to unfold. One case in particular, The Woolley and Roe Case of 1954, served as a potent impetus to plummeting public confidence in spinal procedures. In said case, two men became partially paralyzed for life upon hospital administration of spinal anesthesia. Today, Arachnoiditis affects more females than males probably due, in part, to the popular use of spinal/epidural anesthesia during childbirth. Furthermore, risk for Arachnoiditis is positively correlated with the quantity of surgical and/or anesthetic spinal interventions in an individual’s medical history. In other words, one may be at greater risk for Arachnoiditis should they have had several spinal surgeries and/or injections.
Four fundamental factors dictate the time to diagnosis of Arachnoiditis: (1) any history of conditions and/or procedures involving the spine, (2) the patient's comprehensive medical history report, (3) the patient's symptomatic expression, and (4) specialized tests including radiological confirmation of diagnosis. Initial presentation of symptoms tends to mimic those of other conditions such as failed back surgery syndrome, multiple sclerosis, fibromyalgia and chronic pain syndrome. Therefore, proper diagnoses are often difficult to make, and usually require significant testing and medical history evaluations. Magnetic resonance imaging (MRI) exam with contrast, myelogram followed by a computed tomography (CT) scan, computerized axial tomography (CAT) scan, electromyogram (EMG) and x-ray may be utilized to confirm diagnoses.
Arachnoiditis has no cure. Available treatments concentrate on chronic pain management. Optimal chronic pain management protocols incorporate a variety of therapy modalities including medication, physical therapy, and psychotherapy. Surgical intervention is generally reserved for extreme cases of Arachnoiditis because of the elevated susceptibility to worsening the condition (high risk for scar tissue and fibrosis formation). Medications commonly used include anti-inflammatories, anticonvulsants, and antidepressants. It is recommended that schedule II controlled substances (opiates) are used with extreme caution due to their high risk status for abuse and dependence. Non-medical treatment approaches such as nerve stimulation [ e.g. spinal cord stimulation and transcutaneous electrical nerve stimulation (TENS)] and acupuncture may provide pain relief as well. However, the Cleveland Clinic states that further clinical trials are necessary in determining the efficacy of steroid injections and electrical stimulation. All treatments and/or combinations of treatments should be overseen by the appropriate medical professional(s). External frames, mobility aids and orthotics are examples of common assistive devices used for affected individuals. Being that the symptomatic profile of Arachnoiditis is incredibly extensive and varying, the use of medical/assistive devices is ultimately case dependent.
Primary Aims
The primary aim of the Arachnoiditis Patient Registry is to conduct a prospectively-planned and efficient natural history study that will result in the most comprehensive understanding of the disease and its course and pace over time. Other registry objectives include the following:
Frequently Asked Questions
1. What is a Patient Registry?
A patient registry is a collection of standardized information about a group of patients who share a condition and is used for a variety of purposes such as conducting natural history studies and supporting disease specific clinical trial recruitment.
2. What is a Natural History Study?
A natural history study is a study designed to track the course of a disease over time and includes people who have a specific medical condition or disease and those who are at risk of developing such. This method of research explores the disease in a comprehensive way and identifies demographic, genetic, environmental, and other variables that correlate with the disease and its outcomes. Natural history studies have many potential uses such as patient care best practice developments and clinical trial recruitment.
3. What is a Research Study Sponsor?
An individual, company, institution, or organization that takes responsibility for choosing appropriately trained and experienced researchers as well as the initiation, management, and/or financing of a clinical trial. The study sponsor ensures that the study is conducted in a reputable manner and upholds regulations as they apply to the study.
4. What is a Principal Investigator?
The Principal Investigator is the research group leader or, the person with the primary responsibility for the design and conduct of the research project or study.
5. What is an Institutional Review Board (IRB)?
Any board, committee, or other group formally designated by an institution or investigator to review, approve the initiation of, and to conduct periodic review of research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. Also known as Ethics Committee (EC).
6. What types of data will be collected in the Arachnoiditis Patient Registry?
The data collected is uniform and includes but is not limited to
• Socio-demographics
• Medical and diagnostics
• Treatment and disease progression
• Management of care
• Quality of life
7. How is the data collected?
Data is collected through a secure web-based system developed by the National Organization for Rare Disorders (NORD), an independent non-profit committed to the identification, treatment, and cure of all 7,000 rare diseases. Study participants respond to questions grouped within a series of surveys developed per study standards and in collaboration with disease specific experts.
8. Who is a study participant?
A study participant is the individual who takes part in a research study and whose information is collected for that research. Study participants may consent to enter and share their own personal data.
9. Who is a reporter/respondent?
A reporter/respondent is an individual who completes the surveys on behalf of the patient/study participant, when they are unable to do so on their own behalf.
10. What is a legally authorized representative (LAR)?
An individual who is authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial. The LAR may be a parent, grandparent, caregiver, or guardian who has the legal authority to grant consent on behalf of another who is eligible to participate in research. When a LAR acts on behalf of a study participant, he/she is considered to be the reporter/respondent in the research.
11. What is an Informed Consent?
The Office for Human Research Protections (OHRP) states that, “… the informed consent process is the critical communication link between the prospective human subject and an investigator beginning with the initial approach of an investigator to the potential subject (e.g. through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study. […] The informed consent process involves three key features: (1) disclosing to potential research subjects’ information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.”1
12. Who can join the study?
This study is open to anyone who has a Arachnoiditis.
13. Is there a cost to participate?
There is no cost to the patient to join this study. The National Organization for Rare Disorders absorbs the cost of the registry for its members.
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