Pain, AcuteNCT03609957
Exercise and Pain in Non-Hispanic Blacks and Whites
A study testing Aerobic Exercise Training and Interval Training in people with Pain, Acute and Pain, Neuropathic, run by Georgia State University at 1 site in United States.
Trial summary
Non-Hispanic Blacks tend to report higher levels of pain, experience pain more frequently, and be under-treated for pain compared to non-Hispanic Whites. Acute (single session) exercise is known to be effective at reducing pain but it is unknown what effect chronic exercise training has on pain responses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Pain, Neuropathic, Analgesia
- What is being tested?
- Aerobic Exercise Training and Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Normotensive
- Identify as non-Hispanic Black or non-Hispanic White
- Healthy enough to participate in regular exercise
- Not taking any medications other than birth control
Who cannot join
- Heart disease (high blood pressure, previous stroke or heart attack)
- Type 1 or 2 diabetes
- History of cancer treated with chemotherapy
- History of nerve damage
- History of chronic pain
- Current smoker/tobacco user or quit less than 1 year ago
Show all 9Show fewer
- Skin disorders (psoriasis, etc.)
- Pregnant
- Taking any medications other than birth control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise on Pain Responses in Non-Hispanic Blacks and Whites
Non-Hispanic Blacks tend to report higher levels of pain, experience pain more frequently, and be under-treated for pain compared to non-Hispanic Whites. Acute (single session) exercise is known to be effective at reducing pain but it is unknown what effect chronic exercise training has on pain responses. The broad goal of this study is to determine whether regular exercise training is more effective at reducing pain responses in non-Hispanic Blacks compared to non-Hispanic Whites. The investigators are interested in comparing regular aerobic exercise training versus high-intensity interval training.
Read the detailed description
Racial discrepancy in the experience of pain is well documented within the literature. Non-Hispanic Blacks (NHB) report greater amounts and severity of clinical pain compared to non-Hispanic Whites (NHW) in a variety of clinical conditions. NHB also experience greater pain-related symptoms and disability, regardless of descriptive factors such as age, gender, and socioeconomic status or clinical factors such as comorbidities and duration of disease. Further, NHB tend to be medically undertreated for pain, regardless of nearly identical reporting of pain level and severity compared with NHW. Not only is adequate pain treatment infrequent, but many pain treatments are less effective in NHB than in NHW, commonly resulting in less reduction of pain severity in this population.
In comparison to NHW, NHB report greater sensitivity to several types of pain, including heat pain, cold pressor pain, ischemic pain, and electrical stimulation. NHB show increased temporal summation, implying central nervous system hypersensitivity and hyperexcitability to noxious (painful) stimuli. Specifically, regarding experimental heat pain, NHB differ minimally in pain threshold or ratings of pain intensity compared to NHW, but perceive greater unpleasantness of pain and show a lower pain tolerance. The physiological mechanisms underlying this racial discrepancy remain unknown.
Experimental pain assessment is valuable in understanding the experience of pain between individuals. Pain is an individual experience and differs from one to another. However, differences in experimental pain perceived may estimate the clinical pain one would experience. Studies show that greater experimental pain sensitivity is associated with greater experience of day-to-day pain in healthy adults and can predict higher levels of clinical pain in adult patients.
While affective (subjective) pain perception has been the focus of the majority of pain assessment studies, in 2008 Campbell et al. investigated the nociceptive flexion reflex (NFR), an involuntary and objective component of the pain response. The NFR is a spinal-mediated reflex that follows activation of nociceptive A-delta afferents by noxious stimuli. This study shows the NFR threshold in NHB is decreased compared to NHW, implying a physiological difference between these racial groups that may contribute to the discrepancy in pain perception. Skin blood flow via vasodilation, another physiological measure, has been shown to increase in response to noxious thermal stimuli in order to distribute heat away from a singular point in the cutaneous environment and prevent damage. Assessing changes in skin blood flow in response to noxious thermal stimuli may further elucidate physiological differences between races that affect pain perception.
It is important to investigate more effective prevention or treatment methods for pain in NHB. Exercise-induced hypoalgesia (EIH) is characterized by decreased pain sensation following physical exercise. Specifically, EIH leads to decreased sensitivity to noxious (painful) stimuli, increased pain thresholds, increased pain tolerance, and decreased pain ratings. EIH has been shown to occur following several types of exercise, such as acute bouts of submaximal, continuous aerobic exercise and acute bouts of isometric hand-grip exercise. Lending to the knowledge of racial discrepancy in pain perception, a study by Umeda et al. in 2016 showed NHB had a smaller magnitude of EIH compared to NHW following isometric hand-grip exercise, but racial differences in EIH remain incompletely understood.
It is suggested that hypoalgesia following exercise may be due to an overlapping of pain perception and cardiovascular mechanisms. For example, pain regulation and blood pressure control are associated with the same brain stem nuclei. Further, hypertensive individuals have shown reduced sensitivity to noxious (painful) stimuli compared to normotensives, and acute pharmacological elevations in blood pressure have been shown to alter pain perception. Therefore, it is important to investigate alterations in pain perception following both acute (which should elicit elevations in blood pressure) and chronic (which should elicit overall declines in blood pressure) exercise.
Several studies have investigated the effects of submaximal exercise on various types of pain and it is typical to see moderate-intensity continuous (MIC) exercise incorporated into pain management programs (generally 30 minutes of 70% VO2max exercise). However, two studies in particular display data indicating that as workload increases, pain thresholds increase in a stepwise manner. Other studies show EIH occurs more consistently following exercise at higher intensities (> 70% VO2max), indicating that high intensity interval training (HIIT) may produce more beneficial results in affective and/or objective responses to pain than MIC exercise. Several studies have looked at affective pain perception following acute submaximal bouts of aerobic and isometric exercise. Those that have investigated acute HIIT have only examined affective responses. The investigators do not know of any studies that have looked at the acute and chronic effect of MIC exercise and HIIT on affective and objective pain perception in NHB and NH There are three main purposes of this study, and they are as follows: 1) to assess objective and subjective responses to pain in NHB and NHW, 2) to assess the use of acute versus chronic exercise in pain management for NHW and NHB, and 3) to assess the use of MIC exercise versus HITT in pain management for NHW and NHB. The investigators hypothesize that 1) NHB will show decreased skin blood flow response to noxious stimuli compared to NHW prior to exercise training, 2) NHB will report greater pain ratings than NHW prior to exercise training, and 3) chronic HIIT will mitigate the differences in skin blood flow and pain ratings between NHB and NHW.
- Conditions
- Pain, Acute, Pain, Neuropathic, Analgesia, Aerobic Exercise, Exercise Training
- Being tested
- Aerobic Exercise Training, Interval Training
- Medical subject headings
- Acute Pain, Neuralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
Traditional, continuous aerobic exercise (cycling) at a moderate intensity
Interval TrainingOther
High-intensity interval exercise consisting of short bursts of exercise interspersed with rest periods
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Training | Experimental | Moderate intensity (75% heart rate reserve) cycling exercise for 32 minutes, 3 days per week for 5 weeks Receives: Other: Aerobic Exercise Training |
| Interval Training | Experimental | High intensity (95% heart rate reserve) cycling exercise for 20 minutes, 3 days per week for 5 weeks Receives: Other: Interval Training |
| Control | No intervention | Control (no exercise intervention) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin blood flow response to local heating
Vasodilation in response to painful and non-painful heating of the skin
Measured: Baseline (prior to intervention or control) and at the conclusion of the 5-week intervention or control. The post-intervention assessment will be performed no later than 3-5 days after completion of the 5-week intervention or control.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startFeb 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Did not have time to complete this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Wong, Georgia State University
- Investigators
- Brett J Wong, Ph.D., Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609957
- Sponsor's protocol ID
- R01HL141205
- Status last verified
- Dec 2018
- First submitted
- 11 Jul 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The current approved IRB and informed consent state that we will not share participants' data except with applicable oversight bodies (IRB, FDA, OHRP, etc.).
Publications
Green CR, Anderson KO, Baker TA, Campbell LC, Decker S, Fillingim RB, Kalauokalani DA, Lasch KE, Myers C, Tait RC, Todd KH, Vallerand AH. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003 Sep;4(3):277-94. doi: 10.1046/j.1526-4637.2003.03034.x.
PubMed 12974827Klonoff EA. Disparities in the provision of medical care: an outcome in search of an explanation. J Behav Med. 2009 Feb;32(1):48-63. doi: 10.1007/s10865-008-9192-1. Epub 2009 Jan 6.
PubMed 19127421Riley JL 3rd, Wade JB, Myers CD, Sheffield D, Papas RK, Price DD. Racial/ethnic differences in the experience of chronic pain. Pain. 2002 Dec;100(3):291-298. doi: 10.1016/S0304-3959(02)00306-8.
PubMed 12468000Edwards RR, Doleys DM, Fillingim RB, Lowery D. Ethnic differences in pain tolerance: clinical implications in a chronic pain population. Psychosom Med. 2001 Mar-Apr;63(2):316-23. doi: 10.1097/00006842-200103000-00018.
PubMed 11292281Green CR, Baker TA, Sato Y, Washington TL, Smith EM. Race and chronic pain: A comparative study of young black and white Americans presenting for management. J Pain. 2003 May;4(4):176-83. doi: 10.1016/s1526-5900(02)65013-8.
PubMed 14622701Bruce B, Fries JF, Murtagh KN. Health status disparities in ethnic minority patients with rheumatoid arthritis: a cross-sectional study. J Rheumatol. 2007 Jul;34(7):1475-9. Epub 2007 Jun 1.
PubMed 17552045Cano A, Mayo A, Ventimiglia M. Coping, pain severity, interference, and disability: the potential mediating and moderating roles of race and education. J Pain. 2006 Jul;7(7):459-68. doi: 10.1016/j.jpain.2006.01.445.
PubMed 16814685Golightly YM, Dominick KL. Racial variations in self-reported osteoarthritis symptom severity among veterans. Aging Clin Exp Res. 2005 Aug;17(4):264-9. doi: 10.1007/BF03324608.
PubMed 16285190Vallerand AH, Hasenau S, Templin T, Collins-Bohler D. Disparities between black and white patients with cancer pain: the effect of perception of control over pain. Pain Med. 2005 May-Jun;6(3):242-50. doi: 10.1111/j.1526-4637.2005.05038.x.
PubMed 15972088Mechlin B, Heymen S, Edwards CL, Girdler SS. Ethnic differences in cardiovascular-somatosensory interactions and in the central processing of noxious stimuli. Psychophysiology. 2011 Jun;48(6):762-73. doi: 10.1111/j.1469-8986.2010.01140.x. Epub 2010 Oct 29.
PubMed 21039586Anderson KO, Mendoza TR, Valero V, Richman SP, Russell C, Hurley J, DeLeon C, Washington P, Palos G, Payne R, Cleeland CS. Minority cancer patients and their providers: pain management attitudes and practice. Cancer. 2000 Apr 15;88(8):1929-38.
PubMed 10760771Merry B, Campbell CM, Buenaver LF, McGuire L, Haythornthwaite JA, Doleys DM, Edwards RR. Ethnic Group Differences in the Outcomes of Multidisciplinary Pain Treatment. J Musculoskelet Pain. 2011 Jan;19(1):24-30. doi: 10.3109/10582452.2010.538821.
PubMed 21731407Siedlecki SL. Racial variation in response to music in a sample of African-American and Caucasian chronic pain patients. Pain Manag Nurs. 2009 Mar;10(1):14-21. doi: 10.1016/j.pmn.2008.08.003.
PubMed 19264279Campbell CM, Edwards RR, Fillingim RB. Ethnic differences in responses to multiple experimental pain stimuli. Pain. 2005 Jan;113(1-2):20-6. doi: 10.1016/j.pain.2004.08.013.
PubMed 15621360Chapman WP, Jones CM. VARIATIONS IN CUTANEOUS AND VISCERAL PAIN SENSITIVITY IN NORMAL SUBJECTS. J Clin Invest. 1944 Jan;23(1):81-91. doi: 10.1172/JCI101475. No abstract available.
PubMed 16695086
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Pain Responses in Non-Hispanic Blacks and Whites
- ClinicalTrials.gov ID
- NCT03609957
- Acronym / sponsor ID
- R01HL141205
- Conditions
- Pain, Acute, Pain, Neuropathic, Analgesia, Aerobic Exercise, Exercise Training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not have time to complete this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-Hispanic Blacks tend to report higher levels of pain, experience pain more frequently, and be under-treated for pain compared to non-Hispanic Whites. Acute (single session) exercise is known to be effective at reducing pain but it is unknown what effect chronic exercise training has on pain responses. The broad goal of this study is to determine whether regular exercise training is more effective at reducing pain responses in non-Hispanic Blacks compared to non-Hispanic Whites. The investigators are interested in comparing regular aerobic exercise training versus high-intensity interval training.
Detailed description
Racial discrepancy in the experience of pain is well documented within the literature. Non-Hispanic Blacks (NHB) report greater amounts and severity of clinical pain compared to non-Hispanic Whites (NHW) in a variety of clinical conditions. NHB also experience greater pain-related symptoms and disability, regardless of descriptive factors such as age, gender, and socioeconomic status or clinical factors such as comorbidities and duration of disease. Further, NHB tend to be medically undertreated for pain, regardless of nearly identical reporting of pain level and severity compared with NHW. Not only is adequate pain treatment infrequent, but many pain treatments are less effective in NHB than in NHW, commonly resulting in less reduction of pain severity in this population.
In comparison to NHW, NHB report greater sensitivity to several types of pain, including heat pain, cold pressor pain, ischemic pain, and electrical stimulation. NHB show increased temporal summation, implying central nervous system hypersensitivity and hyperexcitability to noxious (painful) stimuli. Specifically, regarding experimental heat pain, NHB differ minimally in pain threshold or ratings of pain intensity compared to NHW, but perceive greater unpleasantness of pain and show a lower pain tolerance. The physiological mechanisms underlying this racial discrepancy remain unknown.
Experimental pain assessment is valuable in understanding the experience of pain between individuals. Pain is an individual experience and differs from one to another. However, differences in experimental pain perceived may estimate the clinical pain one would experience. Studies show that greater experimental pain sensitivity is associated with greater experience of day-to-day pain in healthy adults and can predict higher levels of clinical pain in adult patients.
While affective (subjective) pain perception has been the focus of the majority of pain assessment studies, in 2008 Campbell et al. investigated the nociceptive flexion reflex (NFR), an involuntary and objective component of the pain response. The NFR is a spinal-mediated reflex that follows activation of nociceptive A-delta afferents by noxious stimuli. This study shows the NFR threshold in NHB is decreased compared to NHW, implying a physiological difference between these racial groups that may contribute to the discrepancy in pain perception. Skin blood flow via vasodilation, another physiological measure, has been shown to increase in response to noxious thermal stimuli in order to distribute heat away from a singular point in the cutaneous environment and prevent damage. Assessing changes in skin blood flow in response to noxious thermal stimuli may further elucidate physiological differences between races that affect pain perception.
It is important to investigate more effective prevention or treatment methods for pain in NHB. Exercise-induced hypoalgesia (EIH) is characterized by decreased pain sensation following physical exercise. Specifically, EIH leads to decreased sensitivity to noxious (painful) stimuli, increased pain thresholds, increased pain tolerance, and decreased pain ratings. EIH has been shown to occur following several types of exercise, such as acute bouts of submaximal, continuous aerobic exercise and acute bouts of isometric hand-grip exercise. Lending to the knowledge of racial discrepancy in pain perception, a study by Umeda et al. in 2016 showed NHB had a smaller magnitude of EIH compared to NHW following isometric hand-grip exercise, but racial differences in EIH remain incompletely understood.
It is suggested that hypoalgesia following exercise may be due to an overlapping of pain perception and cardiovascular mechanisms. For example, pain regulation and blood pressure control are associated with the same brain stem nuclei. Further, hypertensive individuals have shown reduced sensitivity to noxious (painful) stimuli compared to normotensives, and acute pharmacological elevations in blood pressure have been shown to alter pain perception. Therefore, it is important to investigate alterations in pain perception following both acute (which should elicit elevations in blood pressure) and chronic (which should elicit overall declines in blood pressure) exercise.
Several studies have investigated the effects of submaximal exercise on various types of pain and it is typical to see moderate-intensity continuous (MIC) exercise incorporated into pain management programs (generally 30 minutes of 70% VO2max exercise). However, two studies in particular display data indicating that as workload increases, pain thresholds increase in a stepwise manner. Other studies show EIH occurs more consistently following exercise at higher intensities (> 70% VO2max), indicating that high intensity interval training (HIIT) may produce more beneficial results in affective and/or objective responses to pain than MIC exercise. Several studies have looked at affective pain perception following acute submaximal bouts of aerobic and isometric exercise. Those that have investigated acute HIIT have only examined affective responses. The investigators do not know of any studies that have looked at the acute and chronic effect of MIC exercise and HIIT on affective and objective pain perception in NHB and NH There are three main purposes of this study, and they are as follows: 1) to assess objective and subjective responses to pain in NHB and NHW, 2) to assess the use of acute versus chronic exercise in pain management for NHW and NHB, and 3) to assess the use of MIC exercise versus HITT in pain management for NHW and NHB. The investigators hypothesize that 1) NHB will show decreased skin blood flow response to noxious stimuli compared to NHW prior to exercise training, 2) NHB will report greater pain ratings than NHW prior to exercise training, and 3) chronic HIIT will mitigate the differences in skin blood flow and pain ratings between NHB and NHW.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Training | Experimental | Other: Aerobic Exercise TrainingModerate intensity (75% heart rate reserve) cycling exercise for 32 minutes, 3 days per week for 5 weeks |
| Interval Training | Experimental | Other: Interval TrainingHigh intensity (95% heart rate reserve) cycling exercise for 20 minutes, 3 days per week for 5 weeks |
| Control | No intervention | –Control (no exercise intervention) group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Normotensive
- Identify as non-Hispanic Black or non-Hispanic White
- Healthy enough to participate in regular exercise
- Not taking any medications other than birth control
Key exclusion criteria (9 listed)
- Heart disease (high blood pressure, previous stroke or heart attack)
- Type 1 or 2 diabetes
- History of cancer treated with chemotherapy
- History of nerve damage
- History of chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingTraditional, continuous aerobic exercise (cycling) at a moderate intensity | Other | Aerobic Exercise Training |
| Interval TrainingHigh-intensity interval exercise consisting of short bursts of exercise interspersed with rest periods | Other | Interval Training |
Primary outcome
Change in skin blood flow response to local heating
Time frame: Baseline (prior to intervention or control) and at the conclusion of the 5-week intervention or control. The post-intervention assessment will be performed no later than 3-5 days after completion of the 5-week intervention or control.
Vasodilation in response to painful and non-painful heating of the skin
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Background: PubMed 12974827Green CR, Anderson KO, Baker TA, Campbell LC, Decker S, Fillingim RB, Kalauokalani DA, Lasch KE, Myers C, Tait RC, Todd KH, Vallerand AH. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003 Sep;4(3):277-94. doi: 10.1046/j.1526-4637.2003.03034.x.
- Background: PubMed 19127421Klonoff EA. Disparities in the provision of medical care: an outcome in search of an explanation. J Behav Med. 2009 Feb;32(1):48-63. doi: 10.1007/s10865-008-9192-1. Epub 2009 Jan 6.
- Background: PubMed 12468000Riley JL 3rd, Wade JB, Myers CD, Sheffield D, Papas RK, Price DD. Racial/ethnic differences in the experience of chronic pain. Pain. 2002 Dec;100(3):291-298. doi: 10.1016/S0304-3959(02)00306-8.
- Background: PubMed 11292281Edwards RR, Doleys DM, Fillingim RB, Lowery D. Ethnic differences in pain tolerance: clinical implications in a chronic pain population. Psychosom Med. 2001 Mar-Apr;63(2):316-23. doi: 10.1097/00006842-200103000-00018.
- Background: PubMed 14622701Green CR, Baker TA, Sato Y, Washington TL, Smith EM. Race and chronic pain: A comparative study of young black and white Americans presenting for management. J Pain. 2003 May;4(4):176-83. doi: 10.1016/s1526-5900(02)65013-8.
- Background: PubMed 17552045Bruce B, Fries JF, Murtagh KN. Health status disparities in ethnic minority patients with rheumatoid arthritis: a cross-sectional study. J Rheumatol. 2007 Jul;34(7):1475-9. Epub 2007 Jun 1.
- Background: PubMed 16814685Cano A, Mayo A, Ventimiglia M. Coping, pain severity, interference, and disability: the potential mediating and moderating roles of race and education. J Pain. 2006 Jul;7(7):459-68. doi: 10.1016/j.jpain.2006.01.445.
- Background: PubMed 16285190Golightly YM, Dominick KL. Racial variations in self-reported osteoarthritis symptom severity among veterans. Aging Clin Exp Res. 2005 Aug;17(4):264-9. doi: 10.1007/BF03324608.
- Background: PubMed 15972088Vallerand AH, Hasenau S, Templin T, Collins-Bohler D. Disparities between black and white patients with cancer pain: the effect of perception of control over pain. Pain Med. 2005 May-Jun;6(3):242-50. doi: 10.1111/j.1526-4637.2005.05038.x.
- Background: PubMed 21039586Mechlin B, Heymen S, Edwards CL, Girdler SS. Ethnic differences in cardiovascular-somatosensory interactions and in the central processing of noxious stimuli. Psychophysiology. 2011 Jun;48(6):762-73. doi: 10.1111/j.1469-8986.2010.01140.x. Epub 2010 Oct 29.
- Background: PubMed 10760771Anderson KO, Mendoza TR, Valero V, Richman SP, Russell C, Hurley J, DeLeon C, Washington P, Palos G, Payne R, Cleeland CS. Minority cancer patients and their providers: pain management attitudes and practice. Cancer. 2000 Apr 15;88(8):1929-38.
- Background: PubMed 21731407Merry B, Campbell CM, Buenaver LF, McGuire L, Haythornthwaite JA, Doleys DM, Edwards RR. Ethnic Group Differences in the Outcomes of Multidisciplinary Pain Treatment. J Musculoskelet Pain. 2011 Jan;19(1):24-30. doi: 10.3109/10582452.2010.538821.
- Individual participant dataSharing planned: No. The current approved IRB and informed consent state that we will not share participants' data except with applicable oversight bodies (IRB, FDA, OHRP, etc.).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett J Wong, Ph.D. principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training and Interval Training in people with Pain, Acute and Pain, Neuropathic, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin blood flow response to local heating (time frame: Baseline (prior to intervention or control) and at the conclusion of the 5-week intervention or control. The post-intervention assessment will be performed no later than 3-5 days after completion of the 5-week intervention or control.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03609957, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.