Arthritis Clinical Trial
Official title:
Symptomatic Management of Lyme Arthritis
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing. It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms. The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility | Inclusion Criteria: - Arthritis - Undergoing Lyme disease testing (Lyme test positive) Exclusion Criteria: - Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative. Underlying diagnosis of rheumatoid or recurrent arthritis Already on scheduled NSAIDs Anything that restricts the prescription of naproxen or acetaminophen: - Hypersensitivity to naproxen (for example: anaphylactic reactions, serious skin reactions) or any component of the formulation; history of aspirin induced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, underlying kidney or liver impairment - Already taking daily NSAIDs (naproxen or ibuprofen) or daily acetaminophen - Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Desiree Neville, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Need for further care as determined by medical record review as number of visits in the system for Lyme arthritis symptoms | Mean repeat medical visits for Lyme arthritis will be compared between treatment arms based on medical record review | 30 days, 60 days, 120 days, 1 year | |
Primary | Change in the degree of joint pain determined by serial visual analog scale for pain via text surveys | 0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization | days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded | |
Primary | Change in the degree of joint redness determined by serial visual analog scale for joint redness via text surveys | 0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization | days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded | |
Primary | Change in degree of joint movement determined by serial visual analog scale for joint movement via text surveys | 0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization | days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded | |
Primary | Change in degree of overall function determined by serial visual analog scale for overall function via text surveys | 0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization | days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded | |
Primary | Time to complete symptom resolution as collected by a yes/no question on the text survey and a branching question asking the date that the symptoms were completely resolved. | If patient answers yes to symptoms completely resolved, they will receive a branching question to input the date. Time from diagnosis to symptom resolution will be compared between the treatment groups. | The branching question will appear on their text survey at any of the time points (days 1, 3, 7, 10, 14, 21, 28, 60) once they enter "yes" to symptoms completely resolved. | |
Secondary | Change in medication compliance as determined by question in serial text survey | Parents enter number of days patient has taken the medication in the past day as well as per day since the last survey in two questions on the text survey with their response being a drop down number list on the text survey- medication compliance will be compared to the number of doses that would be full compliance for that treatment arm | days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) | |
Secondary | Development of medication side effects as determined by question in serial text survey | survey asks parents to describe any medication side effects they feel their child has had - descriptive outcome only | days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) | |
Secondary | Other medications taken as determined by question in serial text survey | Parents are asked to list any medications in addition to their study drug and antibiotic that their child has taken- descriptive outcome only | days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) | |
Secondary | Fever as determined by question in serial text survey | Parents are asked if their child had fever in the 24 hours prior to taking the text survey, duration of fever compared between treatment arms | days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) |
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