An observational study in Chronic Pain Syndrome, Fibromyalgia and Chronic Headache Disorder, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Boston Children's Hospital · Observational
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Among 369 studies in Fibromyalgia with a site in United States — 52 open to participants now, 63 under way, 2 of them phase 3. Fibromyalgia · United States.
Among the 369 studies in Fibromyalgia with a site in United States, this one is the 36th largest by enrollment of the 47 observational ones that give a count, is one of 13 that started in 2022, is one of 47 observational ones, and was the 312th registered.
1,244 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
Browse Fibromyalgia studies →52 of the 369 studies in Fibromyalgia with a site in United States are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 14–26
Spaulding Rehabilitation Hospital · Sites in United States
Ages 21–65
Pulkit Grover · Sites in United States
Ages 18–65
Theranica · Sites in United States, Israel
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 161 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 97 (60%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.
This study: 10 Years to 17 Years · all sexes · no healthy volunteers.
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369 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 61 · Phase 3 64 · Phase 4 24
First in 1994; this study’s year is marked. 13 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 43 is below the median of 100 across 279 observational studies indexed under Fibromyalgia.
Median enrollment 72 across the 320 interventional studies, 200 across the 47 observational. Of the 276 that completed or were terminated, 116 (42%) have results posted.
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101 of 369 have an industry lead sponsor. The 10 most frequent:
Boston Children's Hospital is the lead sponsor of 609 studies on the registry; 148 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Boston Children's Hospital has 2 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
29 of the studies in Fibromyalgia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02979574Memorial Sloan Kettering Cancer CenterPEACE: Comparing Chronic Pain Treatment Options | 2026-11 |
| NCT07116278University of California, San FranciscoTMS-EEG Biomarkers for Chronic Pain | 2026-12 |
| NCT04949100Paul CrawfordMicrocurrent for Fibromyalgia | 2026-12 |
| NCT07525063Duke UniversityPain & Reward Neuromodulation of CNS Circuits | 2026-12 |
| NCT06552728University of California, IrvineThe Effects of Energy Healing in Fibromyalgia | 2026-12 |
Add all 29 to your calendar (.ics) → With an account.
Among the 369 studies in Fibromyalgia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This work will answer two critical questions: 1) Does intensive interdisciplinary pain treatment (IIPT) involving aerobic exercise help normalize pain processing in youth with chronic pain syndromes and 2) Are aerobic fitness levels and the ability to modulate pain inter-related?
Currently, medications are ineffective for improving pain and disability in youth with chronic pain syndromes and identifying non-pharmacologic treatments, such as IIPT, that help strengthen the nervous system's ability to modulate or turn pain signals down will improve outcomes and quality of life for youth suffering from chronic pain. This study will help determine whether exercise based IIPT leads to physiologic improvements in how pain is processed, specifically if youth with chronic pain can better turn pain down during the offset analgesia test after an exercise based IIPT treatment, and also help elucidate the link between a child's aerobic fitness and their ability to modulate pain.
Thermal testing: A computer-controlled temperature paradigm is programmed to deliver each stimulus using the Medoc Thermosensory Analyzer (TSA)-II device (Medoc Ltd. Advanced Medical Systems, Ramat Yishai, Israel). The device operates by a microcomputer-driven 3 cm x 3 cm (9 cm2) Peltier contact thermode secured to the skin by a Velcro band without stretch. Testing is conducted on the non-dominant forearm using 4 locations to minimize skin sensitivity. Participants are blinded to the type of test being performed and expected response patterns.
Assessment of Pain Intensity: During all tests participants rate heat pain intensity continuously in real time using a linear electronic visual analogue scale (eVAS). Participants use their dominant hand to operate a knob on a horizontal sliding eVAS scale (0-100 mm) with the following two anchors: the left defined as "no heat pain sensation" (0 mm) and the right as "most intense heat pain sensation imaginable" (100 mm). Participants are instructed to move the knob on the scale in proportion to perceived heat pain intensity and not temperature intensity during testing.
Determination of the Individualized Test Temperature (ITT): To determine ITT the first temperature stimulus will ramp from baseline (32°C) to 46°C (the 75th percentile heat pain detection threshold for children ages 7-17 years) and held for 5 seconds.[22] The temperature will return to baseline (32°C) for 30 seconds and be repeated three times. If an eVAS of 75/100mm is not consistently reported on all three trials, this paradigm will be repeated at 48ºC. The lowest temperature that consistently evokes an eVAS 75/100mm will be used as the first temperature in all tests.
Offset Analgesia (OA) Test: We will use the same paradigm as our previous study, except for increasing the ITT threshold to 75/100mm.[37] The first temperature (T1) is set to the ITT and held for 5 seconds, followed by a second temperature (T2) 1°Celsius (C) higher for 5 seconds, and then returns to a third temperature (T3) that is equal to T1 for 20 seconds before returning to baseline (32ºC). OA responses are calculated as a percentage of perceived pain reduction following the 1ºC noxious thermal stimulus offset. A larger OA response (i.e., greater pain reduction) reflects a greater ability to actuate pain inhibition.
Control Test: For control tests, T1 and T2 temperatures are identical to those used in the OA paradigm, but T3 is set at the non-noxious baseline temperature (32°C). The control test serves as a physiological discriminative stimulus to examine participants' pain perception in the presence versus absence of a noxious heat stimulus.
Constant Test: For constant tests, the ITT (T1) is applied and held for 30 seconds before returning to baseline (32ºC). The constant test compares the magnitude of habituation and summation occurring during constant and OA tests.
Cardiovascular Endurance Assessment: The Fitkids Treadmill Test (FTT) is a reliable and valid measure of pediatric submaximal cardiovascular endurance.[16; 17] Time to exhaustion (TTE) on the FTT provides an objective, norm-referenced marker of cardiovascular endurance in youth ages 6-18 years and is defined as the total time completed on the test, excluding the warm-up and cool-down phases. Our recent study demonstrated that youth with chronic pain demonstrate impaired cardiovascular endurance compared to age and sex matched peers at baseline and improves significantly after IIPT.[36] The FTT is completed at PPRC admission and discharge as per standard of care for participants who can safely ambulate on a treadmill.
Biopsychosocial Characteristics: A battery of psychosocial and clinical questionnaires are administered as part of routine clinical care at the Mayo Family PPRC and stored in an IRB approved data registry for which Dr. Shulman and Dr. Sethna are co-investigators (P-0015943). Data for responses to these questionnaires will be shared for the current protocol to reduce participant burden. These measures include reliable and valid pediatric questionnaires of physical and emotional functioning including: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety short form 8a ,[42] PROMIS Depressive Symptoms short form 8a,[42] PROMIS Pediatric Pain Interference short form 8a,[42] Central Sensitization Inventory,[27; 28] Functional Disability Inventory.[21; 43] Participant characteristics at IIPT admission including, age, sex, diagnosis, pain intensity ratings, time since symptom onset, and medications will also be included to evaluate similarities and differences among OA responders and non-responders for Aim 3 based on prior research.[23; 25; 33; 39]
Youth with all types of chronic pain syndromes (including but not limited to: headaches, abdominal pain, complex regional pain syndrome, amplified pain syndrome) admitted to the Mayo Family Pediatric Pain Rehabilitation Center for intensive interdisciplinary pain treatment.
Inclusion Criteria:]
i) age 10-17 years
ii) first test completed within 5 days of admission
iii) established diagnosis of primary or secondary chronic pain
iv) report of constant moderate pain (≥ 5/10 on a numeric rating scale of 0-10 points) for at least 3 months duration
v) stable use of medications for at least one week prior to the study visit.
Exclusion Criteria:
i) presence of allodynia in either upper extremity
ii) a history of central nervous system, heart, kidney, liver and respiratory system diseases, and psychiatric disorders (e.g., bipolar, conversion, psychosis)
iii) reported consumption of alcohol, cannabis or tobacco products
iv) unable to read English or follow testing instructions
v) intolerant to the thermal test stimulus, or vi) no pain reported at maximum stimulus (48ºC).
We will recruit 38 youth with primary and secondary chronic pain syndromes\[29; 31\] ages 10-17 years who are admitted to the Mayo Family Pediatric Pain Rehabilitation Center at Boston Children's Hospital. This longitudinal cohort study will examine responses to the OA and Fitkids Treadmill tests at 2 timepoints: 1) within 5 days of IIPT admission and 2) within 1 week of IIPT discharge. Twelve participants will complete a 3rd visit within 5 days of the first study visit to examine OA test-retest reliability.
Change in Offset Analgesia
Percent reduction in pain following the small, 1º C stimulus offset.
Time frame: through study completion, an average of 4-6 weeks
Change in Control Test Response
Percent reduction in pain following a large stimulus offset to a non-noxious temperature.
Time frame: through study completion, an average of 4-6 weeks
Change in Constant Test Response
Pain response (area under the curve) during a 30 second constant, moderate heat pain stimulus.
Time frame: through study completion, an average of 4-6 weeks
Change in Cardiovascular Endurance
Total time to exhaustion (minutes) on the Fitkids Treadmill Test.
Time frame: through study completion, an average of 4-6 weeks
Change in Anxiety
PROMIS Pediatric Anxiety short form 8a T-score, range 0-100, higher scores = higher anxiety
Time frame: through study completion, an average of 4-6 weeks
Change in Depressive Symptoms
PROMIS Depressive Symptoms short form 8a T-score, range = 0-100; higher scores = more depressive symptoms
Time frame: through study completion, an average of 4-6 weeks
Change in Pain Interference
PROMIS Pain Interference short form 8a T score; range 0-100; higher scores = higher pain interference
Time frame: through study completion, an average of 4-6 weeks
Change in Central Sensitization
Central Sensitization Inventory Total Score (0-100), higher scores = more central sensitization
Time frame: through study completion, an average of 4-6 weeks
Plan to share: No
Ran from Oct 2022 to primary completion in Nov 2023, 13 months.
Of 81 non-industry observational studies under Fibromyalgia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 109. This study's 13 months is below that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 8 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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