An observational study in Chronic Pain, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 22 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by University of Kansas Medical Center · Observational
Among 1,283 studies in Chronic Pain with a site in United States — 259 open to participants now, 350 under way, 8 of them phase 3. Chronic Pain · United States.
Among the 1,283 studies in Chronic Pain with a site in United States, this one is the 82nd largest by enrollment of the 189 observational ones that give a count, is one of 91 that started in 2018, is one of 189 observational ones, and was the 442nd registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 158 is above the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →259 of the 1,283 studies in Chronic Pain with a site in United States are open now.
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 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 22 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →1,283 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 81 · Phase 2 112 · Phase 3 73 · Phase 4 50
First in 1992; this study’s year is marked. 91 started in 2018.
Median enrollment 60 across the 1,092 interventional studies, 100 across the 189 observational. Of the 847 that completed or were terminated, 386 (46%) have results posted.
209 of 1,283 have an industry lead sponsor. The 10 most frequent:
University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
University of Kansas Medical Center has 6 studies filed under Chronic Pain — fewer than ten, so there is no comparison to draw.
138 of the studies in Chronic Pain with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05703178Phase 3Northwestern UniversityWeb-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia | 2026-11-30 |
| NCT06091202Phase 3Oregon Health and Science UniversityTele-Collaborative Outreach to Rural Patients With Chronic Pain | 2027-05-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT02979574Memorial Sloan Kettering Cancer CenterPEACE: Comparing Chronic Pain Treatment Options | 2026-11 |
| NCT03984565Staci Gruber, Ph.D.PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product | 2026-11 |
Among the 1,283 studies in Chronic Pain with a site in United States, from their registry updates:
The purpose of this study is to learn whether or not certain risk factors and patient characteristics are linked with and possibly can predict the development of chronic pain after lumbar spine surgery.
Participants will be recruited directly by the Candidate and by referral from specialist physicians at the KUMC Marc A. Asher, MD, Comprehensive Spine and Pain Management Center.
Inclusion Criteria For All Participants:
Exclusion Criteria For All Participants:
Inclusion Criteria for Candidates for Lumbar Spine Surgery:
Exclusion Criteria for Candidates for Lumbar Spine Surgery:
Inclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:
Exclusion Criteria for Candidates with Lumbar Failed Back Surgery Syndrome:
Inclusion Criteria for Healthy Volunteers:
Exclusion Criteria for Healthy Volunteers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants have been designated to be a candidate for lumbar spine surgery to treat chronic low back and/or leg pain and you have agreed to proceed with the surgery.
Participants have been diagnosed with having lumbar failed back surgery syndrome and have persistent and moderate-to-severe low back and/or leg pain for more than 6 months after a lumbar spine surgery.
Participants are a healthy volunteer wishing to participate in a research study.
Clinical Pain Severity - 50% Reduction Responders vs Nonresponders
Measured by the Brief Pain Inventory (BPI). The BPI scores are a numerical rating scale and range from 0 to 10. A score of 0 is equal to no pain and a score of 10 is equal to pain as bad as you can imagine.
Time frame: Change from Baseline to Month 6
Fibromylagia-ness (FMness)
2011 Fibromyalgia Survey score is calculated by combining the widespread pain index (WPI) and the Symptom Severity Scale (SSI) to derive a score from 0-31. Scores greater than or equal to 13 indicate a diagnosis of Fibromyalgia. Higher scores indicate the degree of central sensitization present in a given individual.
Time frame: Baseline
PROMIS T-score - Fatigue, Physical Function, Sleep-Related Impairment
PROMIS measures to be included are Depression, Anxiety, Physical Functioning, Fatigue, Sleep Impairment, Emotional Support, and Social Participation. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.
Time frame: Baseline
PROMIS T-score - Anxiety, Depression, Emotional Support, Pain Interference, Satisfaction With Social Roles
PROMIS measures to be included are Depression, Anxiety, Physical Functioning, Fatigue, Sleep Impairment, Emotional Support, and Social Participation. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.
Time frame: Baseline
Oswestry Disability Index
The Oswestry Disability Index will be used to assess low back pain. There are 10 sections on the index. Each section has a possible score of 5. The total possible range of scores is 0 to 50. A score of 0 indicates no pain. A score of 50 indicates the person is bed-bound or exaggerating their symptoms.
Time frame: Baseline
Coping Strategies Questionnaire - CAT
A 6-item catastrophizing scale that measures ways to cope or deal with pain. Each item is scored on a scale of 0-6. Scores can range from 0-36, with the higher the score the higher the rate of catastrophizing.
Time frame: Baseline
Quantitative Sensory Testing (QST) - Pressure Pain Sensitivity by Algometry - Trapezius
Pressure pain sensitivity is measured by Algometry (measured at the trapezius and lumbar spine). It yields a pressure pain threshold value measured in kPA. Tests were performed at the Left and Right trapezius in triplicate at each site and the average is calculated and used for analysis.
Time frame: Baseline
Quantitative Sensory Testing (QST) - Pressure Pain Sensitivity by Algometry - Lower Back
Pressure pain sensitivity is measured by Algometry (measured at the trapezius and lumbar spine). It yields a pressure pain threshold value measured in kPA.Tests were performed at the Left and Right lumbar spine in triplicate at each site and the average is calculated and used for analysis.
Time frame: Baseline
Quantitative Sensory Testing (QST) - Pressure Pain Sensitivity by Multimodal Automated Sensory Testing
Pressure pain sensitivity is measured by the Multimodal Automated Sensory Testing (MAST) System (measured at the thumbnail). It yields a pressure pain threshold value measured in kg/cm2. Thumb Pain30, Pain40, and Pain50 are the pressure intensities that provoke a pain rating of 30/100, 40/100, and 50/100, respectively. Thumb Pain Tolerance is the pressure intensity that provokes a response greater than or equal to 80/100.
Time frame: Baseline
Quantitative Sensory Testing (QST) - Conditioned Pain Modulation (CPM)
Conditioned Pain Modulation as measured at the thumbnail using the MAST. It yields a numerical pain rating difference on a 0-100 numerical scale that can either be positive or negative called CPM magnitude. CPM magnitude will be calculated as the difference (post-pre) in the mean of the three pain ratings given to the test stimulus prior to the conditioning stimuli and the three pain ratings of the test stimulus given during the conditioning stimuli. A reduction in test stimulus rating by conditioning stimulation implies functional (inhibitory) CPM, and the degree of reduction expresses the efficiency of CPM.
Time frame: Change from Post-stimulus test at Baseline visit to Pre-stimulus test at Baseline visit
| Milestone | Candidate for Lumbar Spine Surgery | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|
| Started | 64 | 54 | 40 |
| Completed | 55 | 49 | 40 |
| Not completed | 9 | 5 | 0 |
Measured by the Brief Pain Inventory (BPI). The BPI scores are a numerical rating scale and range from 0 to 10. A score of 0 is equal to no pain and a score of 10 is equal to pain as bad as you can imagine.
| percentage of change | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders |
|---|---|---|
| Clinical Pain Severity - 50% Reduction Responders vs Nonresponders | -83 (-100 to -62.5) | 0 (-12.5 to 15.5) |
2011 Fibromyalgia Survey score is calculated by combining the widespread pain index (WPI) and the Symptom Severity Scale (SSI) to derive a score from 0-31. Scores greater than or equal to 13 indicate a diagnosis of Fibromyalgia. Higher scores indicate the degree of central sensitization present in a given individual.
| Participants | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| FM Negative | 17 | 27 | 26 | 40 |
| FM positive | 4 | 4 | 23 | 0 |
PROMIS measures to be included are Depression, Anxiety, Physical Functioning, Fatigue, Sleep Impairment, Emotional Support, and Social Participation. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.
| units on a scale | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Fatigue v1.0 8a | 58.80 (51.40 to 64.40) | 56.40 (48.10 to 61.50) | 62.40 (57.10 to 66.10) | 42 (33.10 to 47.70) |
| Physical Function v2.0 8b | 34.70 (31.80 to 36.30) | 35.30 (30.40 to 40.60) | 34.30 (32.00 to 36.30) | 60.10 (52.80 to 60.10) |
| Sleep-Related Impairment v1.0 8a | 60.90 (52.50 to 66.00) | 59.70 (50.50 to 62.90) | 62.30 (53.10 to 66.10) | 44.60 (38.40 to 50.30) |
PROMIS measures to be included are Depression, Anxiety, Physical Functioning, Fatigue, Sleep Impairment, Emotional Support, and Social Participation. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.
| units on a scale | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Anxiety v1.0 8a | 50.3 (44 to 61) | 49.8 (43.9 to 54.6) | 51.00 (45.90 to 60.10) | 43.35 (37.10 to 50.60) |
| Depression v1.0 8a | 54.5 (49.6 to 56.8) | 52.0 (38.2 to 56.9) | 54.00 (45.50 to 58.60) | 41.35 (38.20 to 49.60) |
| Emotional Support v2.0 4a | 52.1 (48.9 to 62) | 62.0 (48.9 to 62.0) | 56.20 (48.90 to 62.00) | 62.00 (48.90 to 62.00) |
| Pain Interference v2.0 8b | 66.9 (64.7 to 72.2) | 61.6 (58.4 to 70.1) | 66.20 (61.60 to 67.60) | 40.70 (40.70 to 40.70) |
| Satisfaction with Social Roles v1.0 4a | 37.5 (30.1 to 44.8) | 41.8 (30.1 to 51.8) | 37.40 (34.90 to 43.00) | 57.50 (51.80 to 63.70) |
The Oswestry Disability Index will be used to assess low back pain. There are 10 sections on the index. Each section has a possible score of 5. The total possible range of scores is 0 to 50. A score of 0 indicates no pain. A score of 50 indicates the person is bed-bound or exaggerating their symptoms.
| units on a scale | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Oswestry Disability Index | 42 (32 to 54) | 40 (28 to 58) | 44 (38 to 56) | 1 (0 to 3) |
A 6-item catastrophizing scale that measures ways to cope or deal with pain. Each item is scored on a scale of 0-6. Scores can range from 0-36, with the higher the score the higher the rate of catastrophizing.
| score on a scale | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Coping Strategies Questionnaire - CAT | 8 (5 to 16) | 2 (0 to 12) | 8 (3 to 13) | 0.50 (0 to 4) |
Pressure pain sensitivity is measured by Algometry (measured at the trapezius and lumbar spine). It yields a pressure pain threshold value measured in kPA. Tests were performed at the Left and Right trapezius in triplicate at each site and the average is calculated and used for analysis.
| kPA | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Left Trapezius | 287.2 (209.8 to 377.7) | 303.7 (208.3 to 352.3) | 227.3 (175.3 to 310.3) | 280.3 (212 to 368.7) |
| Right Trapezius | 299.7 (197.8 to 381.7) | 263.7 (171.7 to 349.0) | 251.5 (198.3 to 309.0) | 285.7 (213.3 to 331.0) |
Pressure pain sensitivity is measured by Algometry (measured at the trapezius and lumbar spine). It yields a pressure pain threshold value measured in kPA.Tests were performed at the Left and Right lumbar spine in triplicate at each site and the average is calculated and used for analysis.
| kPA | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Left Back | 342.3 (178.2 to 456.5) | 291.5 (196.7 to 341) | 221.3 (108.3 to 363.0) | 332.7 (297.0 to 403.7) |
| Right Back | 344.2 (188 to 437) | 328 (168.3 to 413) | 173.3 (145.7 to 318.3) | 321.0 (274.0 to 433.3) |
Pressure pain sensitivity is measured by the Multimodal Automated Sensory Testing (MAST) System (measured at the thumbnail). It yields a pressure pain threshold value measured in kg/cm2. Thumb Pain30, Pain40, and Pain50 are the pressure intensities that provoke a pain rating of 30/100, 40/100, and 50/100, respectively. Thumb Pain Tolerance is the pressure intensity that provokes a response greater than or equal to 80/100.
| kg/cm^2 | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Thumb Pain30 | 3.86 (2.66 to 4.37) | 3.69 (2.72 to 5.33) | 3.0 (2.0 to 3.7) | 4.0 (3.1 to 5.0) |
| Thumb Pain40 | 4.60 (3.26 to 5.08) | 4.01 (2.74 to 5.88) | 3.6 (2.5 to 4.2) | 4.6 (3.7 to 5.4) |
| Thumb Pain50 | 5.35 (3.86 to 5.78) | 4.23 (3.31 to 6.52) | 4.0 (2.8 to 4.6) | 5.3 (4.1 to 5.9) |
| Thumb Pain Tolerance | 7.50 (5.65 to 7.89) | 4.98 (4.13 to 8.47) | 5.6 (4.8 to 6.2) | 6.6 (5.7 to 7.9) |
Conditioned Pain Modulation as measured at the thumbnail using the MAST. It yields a numerical pain rating difference on a 0-100 numerical scale that can either be positive or negative called CPM magnitude. CPM magnitude will be calculated as the difference (post-pre) in the mean of the three pain ratings given to the test stimulus prior to the conditioning stimuli and the three pain ratings of the test stimulus given during the conditioning stimuli. A reduction in test stimulus rating by conditioning stimulation implies functional (inhibitory) CPM, and the degree of reduction expresses the efficiency of CPM.
| units on a scale | Lumbar Spine Surgery - Responders | Lumbar Spine Surgery - Non-Responders | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer |
|---|---|---|---|---|
| Quantitative Sensory Testing (QST) - Conditioned Pain Modulation (CPM) | -3.33 (-13.33 to 1.67) | -1.67 (-15 to 1.67) | -5.0 (-15.0 to 0) | -1.7 (-8.3 to 3.3) |
Collected over AEs were assessed via pt-report or via EMR notification for the duration of the study, approximately 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lumbar Spine Surgery Candidates | 1/55 (1.8%) | 1/55 (1.8%) | 0/55 (0%) |
| Healthy Control Participants | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Failed Back Surgery Syndrome Participants | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Event | Lumbar Spine Surgery Candidates | Healthy Control Participants | Failed Back Surgery Syndrome Participants |
|---|---|---|---|
| DeathGeneral disorders | 1/55 | — | — |
| Age, Continuous(years) | Candidate for Lumbar Spine Surgery | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer | Total |
|---|---|---|---|---|
| Median | 55 (45 to 64) | 53 (44 to 61) | 52 (42 to 61) | 54 (43 to 62) |
| Sex: Female, Male(Participants) | Candidate for Lumbar Spine Surgery | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer | Total |
|---|---|---|---|---|
| Female | 32 | 33 | 21 | 86 |
| Male | 23 | 16 | 19 | 58 |
| Ethnicity (NIH/OMB)(Participants) | Candidate for Lumbar Spine Surgery | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 3 | 7 |
| Not Hispanic or Latino | 53 | 47 | 37 | 137 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Candidate for Lumbar Spine Surgery | Lumbar Failed Back Surgery Syndrome | Healthy Volunteer | Total |
|---|---|---|---|---|
| Race — White | 50 | 42 | 37 | 129 |
| Race — Black, African American | 4 | 3 | 1 | 8 |
| Race — American Indian, Alaskan | 0 | 1 | 0 | 1 |
| Race — Asian | 0 | 1 | 1 | 2 |
| Race — Native Hawaiian or Pacific Islander | 1 | 0 | 0 | 1 |
| Race — Other, Unknown | 0 | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Apr 2023, 57 months.
Results were first posted in Mar 2026, 2 years 10 months after primary completion.
Of 336 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 57 months is above that.
Counting every sponsor, half of 362 studies reached it within 24 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center →