An interventional study of Study assessments in Low Back Pain, PTSD and Depression, sponsored by Palmer College of Chiropractic. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-18.
Sponsored by Palmer College of Chiropractic · Not applicable, Interventional, and Other
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Among 11 studies in Low Back Pain by Palmer College of Chiropractic — none open to participants now, none under way, none of them phase 3. Low Back Pain · Palmer College of Chiropractic.
Among the 11 studies in Low Back Pain by Palmer College of Chiropractic, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 10 with no phase, and was the 9th registered.
2,923 studies on the registry are indexed under Low Back Pain; 579 are open to participants now.
Browse Low Back Pain studies →None of the 11 studies in Low Back Pain by Palmer College of Chiropractic is open now. The open studies under Low Back Pain, anywhere →
Of the 332 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 210 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2018.
This study's enrollment of 40 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Median enrollment 82 across the 11 interventional studies. Of the 11 that completed or were terminated, 7 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
Palmer College of Chiropractic is the lead sponsor of 14 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Low Back Pain by Palmer College of Chiropractic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The primary objectives of this pilot trial are to evaluate the feasibility, safety and acceptability of an integrative care pathway that includes chiropractic care, for the coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP), with an emphasis on those with mental health comorbidity, in preparation for the conduct of an appropriately powered multi-site randomized controlled trial (RCT). The secondary objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and 10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use in a future RCT; and 3) determine preliminary intervention effect sizes and variability to aid in sample size determination for a future RCT. The investigators hypothesize that chiropractic care offers relief for pain and mental health symptoms through the direct effects of treatment-focused CMT, as well as through the indirect, non-specific effects of the team-based relationship with the clinician.
This pilot study is a single-arm trial. All participants will be asked to complete study outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool (STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life, General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability, mental health, quality of life enjoyment and satisfaction. All participants will receive up to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and 10 of the study.
The coinciding problems of chronic pain and mental illness are of great concern for patients seeking care within the Department of Veterans Affairs (VA) healthcare facilities. Of the 5.7 million veterans treated in VA facilities in 2012, more than half reported chronic pain syndromes, including chronic low back pain (cLBP). Veterans also experience many mental health comorbidities, such as depression, anxiety, post-traumatic stress disorder (PTSD), and substance abuse. Veterans in pain are often managed using prescription drugs, including opioids, psychotropic medications, and sleep agents. Non-pharmacological treatments for chronic pain, which also may provide relief of mental health symptoms, may be welcomed complementary therapies for veterans suffering from these conditions.
Patients with musculoskeletal (MSK) pain and pain at multiple locations often report depression, anxiety and other mental health symptoms. Chronic pain may perpetuate mental health comorbidity as these conditions share common pathophysiological pathways. Research has shown that the non-specific effects of empathetic doctor communication and therapeutic alliance improves clinical outcomes. The investigators hypothesize that chiropractic care offers relief for pain and mental health symptoms through the direct effects of treatment-focused chiropractic manipulative therapy (CMT), as well as through the indirect, non-specific effects of the team-based relationship with the clinician.
However, chiropractic care is not delivered in isolation from other treatments within the VA. Thus, the investigators will test a feasible, effective, patient-centered, guideline-based, integrative care model that integrates chiropractic into VA Patient Aligned Care Teams (PACTs). This integrative care pathway will involve primary care providers, mental health professionals, and doctors of chiropractic (DCs) engaged in the treatment of veterans with cLBP, with or without mental health comorbidity. While DCs are providing services within VA in increasing numbers over the past 13 years, as with any new service, adoption and appropriate placement faces challenges. Many VA providers may know little about the clinical approaches used by DCs. Similarly, DCs may not be fully aware of the processes involved in the delivery of primary care services within VA or the healthcare needs of veterans with mental illness. The purpose of this pilot clinical trial is to evaluate the feasibility, safety and patient perceptions of an integrative care pathway, developed through a consensus-based process, for the coordinated care for VA patients with cLBP and mental health comorbidity.
As this is a pragmatic trial, chiropractic care will consist of usual chiropractic procedures for the management chronic low back pain (cLBP). Treatment approaches will be based on clinical evaluation, which may include diagnostic testing, to determine a working diagnosis, rule out pathology, and/or to screen for conditions requiring referral or other co-management. The investigators anticipate that chiropractic care often will include some form of chiropractic manipulative therapy (CMT). DCs will likely also recommend rehabilitative exercise, stretching, or nutritional and lifestyle advice based upon clinical findings and patient goals/preferences. The investigators will evaluate treatments through electronic health records (EHR) data abstraction following completion of chiropractic care at Week 10. As per typical VA care, DCs will monitor the participant's health status throughout the trial and initiate referrals as clinically indicated. Referrals to primary care and mental health providers will be consistent with the chiropractic integrated care pathway developed during a prior phase of the study. The investigators anticipate the most common communication and referral methods will occur through note-review and countersign procedures, which are already established among VA providers using the VA electronic health record, but may also occur in person or via phone conversations. Chiropractic care will be administered by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.
Other: Study assessments
All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.
Duration of Study Recruitment
As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.
Time frame: From date of first participant enrolled to date last participant is enrolled, up to 8 months.
Diversity of Patient Demographics
As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.
Time frame: Screening through baseline
Number of Participants Engaged in Use of MyHealthEVet
As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.
Time frame: 10 weeks from Baseline
Acceptability
Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.
Time frame: At Week 10 of the study
Number of Participants With Reported Adverse Events
Safety for this study will be assessed by the number of adverse events counted and recorded.
Time frame: 10 weeks from Baseline
Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up
As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.
Time frame: 10 weeks from Baseline
Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)
Time frame: Baseline visit and weeks 5 and 10
Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense \& Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.
Time frame: Baseline visit and weeks 5 and 10
STarT Back Screening Tool
This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).
Time frame: Baseline visit and week 10
Self-Efficacy for Managing Symptoms (SF8a)
Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).
Time frame: Baseline visit and week 10
Patient Health Questionnaire (PHQ-9)
This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.
Time frame: Baseline visit and week 10
Generalized Anxiety Disorder-7 (GAD-7)
This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.
Time frame: Baseline visit and week 10
Alcohol Use Disorders Identification Test (AUDIT)
Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).
Time frame: Baseline visit and week 10
PTSD Checklist-Civilian (PCL-C)
This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).
Time frame: Baseline visit and week 10
Healing Encounters and Attitudes Lists (HEAL)
HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).
Time frame: After the initial chiropractic visit
Pain, Enjoyment, and General Activity (PEG)
The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).
Time frame: Week 3 and Week 7
| Milestone | Treatment Arm |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.
| months | Treatment Arm |
|---|---|
| Duration of Study Recruitment | 6 |
As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.
| Participants | Treatment Arm |
|---|---|
| Multi-racial | 1 |
| White | 36 |
| Other or unspecified | 3 |
| Hispanic or Latino | 2 |
| Male | 31 |
| 18-35 years | 6 |
| 36-54 years | 16 |
| 55+ years | 18 |
As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.
| Participants | Treatment Arm |
|---|---|
| Number of Participants Engaged in Use of MyHealthEVet | 15 |
Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.
| Participants | Treatment Arm |
|---|---|
| Viewed as Positive | 10 |
| Viewed as Mixed Positive/Negative | 9 |
| Viewed as Negative | 5 |
Safety for this study will be assessed by the number of adverse events counted and recorded.
| Participants | Treatment Arm |
|---|---|
| Number of Participants With Reported Adverse Events | 6 |
As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.
| Participants | Treatment Arm |
|---|---|
| Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up | 8 |
The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)
| score on a scale | Treatment Arm |
|---|---|
| Baseline | 12.9 ± 5.1 |
| Week 5 | 10.2 ± 5.5 |
| Week 10 | 9.6 ± 6.2 |
PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense \& Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.
| score on a scale | Treatment Arm |
|---|---|
| Worst Pain, Baseline | 6.4 ± 1.7 |
| Worst Pain, Week 5 | 5.7 ± 2.0 |
| Worst Pain, Week 10 | 5.3 ± 2.2 |
| Average Pain, Baseline | 5.4 ± 1.4 |
| Average Pain, Week 5 | 4.8 ± 1.8 |
| Average Pain, Week 10 | 3.9 ± 2.0 |
This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).
| Participants | Treatment Arm |
|---|---|
| Baseline — Low Risk | 2 |
| Baseline — Medium Risk | 17 |
| Baseline — High Risk | 13 |
| Baseline — Missing | 8 |
| Week 10 — Low Risk | 9 |
| Week 10 — Medium Risk | 12 |
| Week 10 — High Risk | 7 |
| Week 10 — Missing | 12 |
Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).
| score on a scale | Treatment Arm |
|---|---|
| Baseline | 41.6 ± 6.4 |
| Week 10 | 43.5 ± 8.2 |
This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.
| score on a scale | Treatment Arm |
|---|---|
| Baseline | 9.7 ± 5.6 |
| Week 10 | 8.6 ± 5.8 |
This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.
| score on a scale | Treatment Arm |
|---|---|
| Baseline | 7.7 ± 5.6 |
| Week 10 | 6.8 ± 5.3 |
Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).
| score on a scale | Treatment Arm |
|---|---|
| Baseline | 2.2 ± 2.8 |
| Week 10 | 1.7 ± 1.9 |
This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).
| score on a scale | Treatment Arm |
|---|---|
| Baseline | 40.3 ± 18.1 |
| Week 10 | 40.1 ± 19.3 |
HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).
| score on a scale | Treatment Arm |
|---|---|
| Patient-Provider Connection - T-Score | 60.9 ± 10.6 |
| Healthcare Environment - T-Score | 54.4 ± 8.4 |
| Treatment Expectancy - T-Score | 54.6 ± 11.5 |
| Positive Outlook - T-Score | 52.0 ± 10.4 |
| Spirituality - T-Score | 50.9 ± 13.3 |
| Attitudes toward CAM - T-Score | 56.0 ± 9.6 |
The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).
| score on a scale | Treatment Arm |
|---|---|
| Average pain, Week 3 | 5.1 ± 2.0 |
| Average pain, Week 7 | 4.8 ± 2.0 |
| Enjoyment of Life Pain Interference, Week 3 | 5.3 ± 2.2 |
| Enjoyment of Life Pain Interference, Week 7 | 4.7 ± 2.5 |
| General Activity Pain Interference, Week 3 | 5.2 ± 2.2 |
| General Activity Pain Interference, Week 7 | 4.7 ± 2.7 |
| Overall PEG-3 Score, Week 3 | 5.2 ± 2.0 |
| Overall PEG-3 Score, Week 7 | 4.7 ± 2.3 |
Collected over Baseline to 10 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 0/40 (0%) | 0/40 (0%) | 5/40 (12.5%) |
| Event | Treatment Arm |
|---|---|
| Muscle painMusculoskeletal and connective tissue disorders | 5/40 |
| Age, Categorical(Participants) | Treatment Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 11 |
| Age, Continuous(years) | Treatment Arm |
|---|---|
| Mean | 53.3 ± 15.1 |
| Sex: Female, Male(Participants) | Treatment Arm |
|---|---|
| Female | 9 |
| Male | 31 |
| Race/Ethnicity, Customized(Participants) | Treatment Arm |
|---|---|
| Race — Unknown | 1 |
| Race — White | 36 |
| Race — Multi-racial | 1 |
| Race — Declined to Answer | 2 |
| Race/Ethnicity, Customized(Participants) | Treatment Arm |
|---|---|
| Ethnicity — Hispanic or Latino | 2 |
| Ethnicity — Not Hispanic or Latino | 38 |
| Region of Enrollment(participants) | Treatment Arm |
|---|---|
| United States | 40 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Feasibility/pilot study
Ran from Feb 2018 to primary completion in Nov 2018, 8 months.
Results were first posted in May 2020, 1 year 6 months after primary completion.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's 8 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Palmer College of Chiropractic