Arthritis, Lyme Arthritis, Lyme Disease
Conditions
Keywords
Lyme Arthritis, Lyme, Lyme Disease, Arthritis, NSAID
Brief summary
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.
Detailed description
Specific Aims: 1. Demonstrate feasibility to ensure adequate patient enrollment and symptomatic follow-up of patients with Lyme arthritis. 2. Develop pilot data necessary for sample size and power calculations: The purpose of the research study is to evaluate whether there is symptomatic benefit of schedule NSAID therapy in patients with Lyme arthritis diagnosis. 1. Quantification of antibiotic-refractory Lyme arthritis in our population 2. Symptomatic outcomes of patients with Lyme arthritis on scheduled NSAIDs versus those not placed on scheduled NSAIDs (duration to resolution and number of patients with resistant arthritis) 3. Assess side effects of patients with Lyme arthritis placed on scheduled NSAIDs versus those not placed on scheduled NSAIDs 4. Assess changes in resources (follow-up visits, further prescriptions) required for patients taking scheduled NSAIDs versus not taking scheduled NSAIDs Background: Lyme disease is the systemic tick-borne disease caused by Borrelia burgdorferi infection, and is endemic to an expanding portion of the United States. Lyme arthritis is a common presentation of Lyme disease. While Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged inflammatory arthritis. Research suggests excessive up-regulation of the inflammatory process in patients with prolonged symptoms. The over-expressed pro- inflammatory cell mediators are downstream of NSAID inhibition, which would suggest NSAIDs may be beneficial in these patients. In fact, there is data that NSAIDs and/or disease-modifying anti-rheumatic drugs (DMARDs) may be beneficial in refractory Lyme arthritis cases, once diagnosed as refractory. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis 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. There are no known methods to identify patients who will develop antibiotic-refractory Lyme arthritis. This work is important to delineate optimal timing and duration of NSAIDs given the research that shows the anti- inflammatory effects during healing can potentially delay recovery. Significance: While antibiotic-refractory Lyme arthritis has been studied at a microbiologic/cytokine level as well as evaluated in terms of treatment once patients have been deemed antibiotic refractory, to our knowledge there are no published studies evaluating prevention. With no literature looking at the question of NSAIDs for the prevention of antibiotic- refractory Lyme arthritis, this pilot study is needed to adequately calculate sample size and power calculations for a large-scale multicenter study. There is anecdotal data from the Rheumatology and Infectious Disease departments at the UPMC Children's Hospital of Pittsburgh that early scheduled NSAIDs may decrease refractory cases, but there has been no formal evaluation into this question. Retrospective evaluation is challenging since the medications in question (NSAIDs) are over the counter, and clinicians may recommend scheduled or intermittent NSAID therapy without documentation, and certainly without prescriptions in the medical record. Many patients with refractory Lyme arthritis are placed on NSAIDs, but given the question of delayed healing with inhibition of prostaglandins during the healing phase of inflammation, the question of whether NSAIDs are beneficial in patients to prevent refractory arthritis is worthwhile rather than the current process of variable NSAID prescription.
Interventions
Patients will be randomized to an NSAID (naproxen)
Patients will be randomized to acetaminophen
Sponsors
Study design
Intervention model description
Prospective, randomized, controlled, non blinded
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey | Symptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter yes to symptoms completely resolved | If patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution |
| Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected | 0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey |
| Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected | 0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey |
| Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected | 0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey |
| Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected | 0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Compliance as Determined by Question in Serial Text Survey | days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) | 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 |
| The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) | survey asks parents to describe any medication side effects they feel their child has had - descriptive outcome only |
| The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) | Parents are asked to list any medications in addition to their study drug and the prescribed antibiotic that their child has taken- descriptive outcome only |
| Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) | Parents are asked if their child had fever in the 24 hours prior to taking the text survey |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 30 days, 60 days, 120 days, 1 year | Mean repeat medical visits for Lyme arthritis will be compared between treatment arms based on medical record review |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NSAID Naproxen at weight based standard dose given bid daily until symptoms resolve
Naproxen: Patients will be randomized to an NSAID (naproxen) | 1 |
| Acetaminophen Acetaminophen at weight based standard dose given qid until symptoms resolve
Acetaminophen: Patients will be randomized to acetaminophen | 2 |
| NSAID First, Then Acetaminophen Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve
Naproxen: Patients will be randomized to an NSAID (naproxen)
Acetaminophen: Patients will be randomized to acetaminophen | 0 |
| Standard Care Symptom observation only | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | NSAID | Acetaminophen | NSAID First, Then Acetaminophen | Standard Care | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9 years | 6 years | — | — | 7 years |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | — | — | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | — | — | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 2 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 | 0 / 0 | 0 / 0 |
Outcome results
Joint Movement Reported 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
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected
Population: Not all text survey instances completed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NSAID | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Enrollment, Day 0 | 35 score on a scale |
| NSAID | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 3 | 86 score on a scale |
| NSAID | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 7 | 100 score on a scale |
| NSAID | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 21 | 100 score on a scale |
| NSAID | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 28 | 100 score on a scale |
| NSAID | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 1 | 50 score on a scale |
| Acetaminophen | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Enrollment, Day 0 | 50 score on a scale |
| Acetaminophen | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 3 | 78 score on a scale |
| Acetaminophen | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 1 | 47 score on a scale |
| Acetaminophen | Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys | Day 14 | 84 score on a scale |
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys
0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey
Time frame: days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
Population: VAS score for pain across all groups
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NSAID | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Enrollment, Day 0 | 62 score on a scale |
| NSAID | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 7 | 0 score on a scale |
| NSAID | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 10 | 0 score on a scale |
| NSAID | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 21 | 0 score on a scale |
| NSAID | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 28 | 0 score on a scale |
| NSAID | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 1 | 50 score on a scale |
| NSAID | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 3 | 16 score on a scale |
| Acetaminophen | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Enrollment, Day 0 | 58 score on a scale |
| Acetaminophen | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 3 | 26 score on a scale |
| Acetaminophen | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 1 | 49.5 score on a scale |
| Acetaminophen | Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys | Day 14 | 20 score on a scale |
Joint Redness Reported 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
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected
Population: There was not 100% follow-up with text surveys
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NSAID | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Enrollment, Day 0 | 61 score on a scale |
| NSAID | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 3 | 7 score on a scale |
| NSAID | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 7 | 0 score on a scale |
| NSAID | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 21 | 0 score on a scale |
| NSAID | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 28 | 0 score on a scale |
| NSAID | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 1 | 38 score on a scale |
| Acetaminophen | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Enrollment, Day 0 | 20 score on a scale |
| Acetaminophen | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 3 | 19 score on a scale |
| Acetaminophen | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 1 | 22.5 score on a scale |
| Acetaminophen | Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys | Day 14 | 0 score on a scale |
Overall Function Reported 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
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
Population: Not all text surveys completed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NSAID | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Enrollment, Day 0 | 50 score on a scale |
| NSAID | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 7 | 100 score on a scale |
| NSAID | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 10 | 100 score on a scale |
| NSAID | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 21 | 100 score on a scale |
| NSAID | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 28 | 100 score on a scale |
| NSAID | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 1 | 65 score on a scale |
| NSAID | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 3 | 85 score on a scale |
| Acetaminophen | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Enrollment, Day 0 | 50 score on a scale |
| Acetaminophen | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 3 | 89 score on a scale |
| Acetaminophen | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 1 | 55.5 score on a scale |
| Acetaminophen | Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys | Day 14 | 83 score on a scale |
Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey
If patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution
Time frame: Symptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter yes to symptoms completely resolved
Population: 3 enrolled patients - none of the acetaminophen patients continued until resolution
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NSAID | Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey | 6 days since enrollment |
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
Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Population: Randomized participants, report percentage of medication doses taken that were available. (while still reporting symptoms)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NSAID | Medication Compliance as Determined by Question in Serial Text Survey | Day 7 | 100 percentage of available med doses taken |
| NSAID | Medication Compliance as Determined by Question in Serial Text Survey | Day 10 | 100 percentage of available med doses taken |
| NSAID | Medication Compliance as Determined by Question in Serial Text Survey | Day 3 | 100 percentage of available med doses taken |
| NSAID | Medication Compliance as Determined by Question in Serial Text Survey | Day 1 | 100 percentage of available med doses taken |
| Acetaminophen | Medication Compliance as Determined by Question in Serial Text Survey | Day 3 | 100 percentage of available med doses taken |
| Acetaminophen | Medication Compliance as Determined by Question in Serial Text Survey | Day 1 | 75 percentage of available med doses taken |
| Acetaminophen | Medication Compliance as Determined by Question in Serial Text Survey | Day 14 | 25 percentage of available med doses taken |
Number of Participants Who Reported 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
Time frame: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Population: All enrolled patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NSAID | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 0 (Enrollment) | 1 Participants |
| NSAID | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 7 | 0 Participants |
| NSAID | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 10 | 0 Participants |
| NSAID | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 21 | 0 Participants |
| NSAID | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 28 | 0 Participants |
| NSAID | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 1 | 0 Participants |
| NSAID | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 3 | 0 Participants |
| Acetaminophen | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 0 (Enrollment) | 0 Participants |
| Acetaminophen | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 3 | 0 Participants |
| Acetaminophen | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 1 | 1 Participants |
| Acetaminophen | Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey | Day 14 | 0 Participants |
The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey
Parents are asked to list any medications in addition to their study drug and the prescribed antibiotic that their child has taken- descriptive outcome only
Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Population: randomized participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NSAID | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 7 | 0 Participants |
| NSAID | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 1 | 0 Participants |
| NSAID | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 3 | 0 Participants |
| NSAID | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 10 | 0 Participants |
| NSAID | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 21 | 0 Participants |
| NSAID | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 28 | 0 Participants |
| Acetaminophen | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 14 | 0 Participants |
| Acetaminophen | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 3 | 0 Participants |
| Acetaminophen | The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey | Day 1 | 0 Participants |
The Number of Participants With Reported 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
Time frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution)
Population: Randomized patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NSAID | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 28 | 0 Participants |
| NSAID | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 10 | 0 Participants |
| NSAID | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 21 | 0 Participants |
| NSAID | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 1 | 0 Participants |
| NSAID | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 3 | 0 Participants |
| NSAID | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 7 | 1 Participants |
| Acetaminophen | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 1 | 0 Participants |
| Acetaminophen | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 14 | 0 Participants |
| Acetaminophen | The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey | Day 3 | 0 Participants |
Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame
Mean repeat medical visits for Lyme arthritis will be compared between treatment arms based on medical record review
Time frame: 30 days, 60 days, 120 days, 1 year
Population: All patients were analyzed for return visits by: 30 days, 60 days, 120 days, 1 year
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NSAID | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 30 days | 0 return visits for Lyme arthritis symptom |
| NSAID | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 60 days | 0 return visits for Lyme arthritis symptom |
| NSAID | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 120 days | 0 return visits for Lyme arthritis symptom |
| NSAID | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 1 year | 0 return visits for Lyme arthritis symptom |
| Acetaminophen | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 1 year | 0 return visits for Lyme arthritis symptom |
| Acetaminophen | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 30 days | 0 return visits for Lyme arthritis symptom |
| Acetaminophen | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 120 days | 0 return visits for Lyme arthritis symptom |
| Acetaminophen | Need for Further Care as Determined by Medical Record Review as Mean Number of Visits in the System for Lyme Arthritis Symptoms During Each Time Frame | 60 days | 0 return visits for Lyme arthritis symptom |