An interventional study of HVLA-SM in Low Back Pain, sponsored by Palmer College of Chiropractic. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-31.
Sponsored by Palmer College of Chiropractic · Not applicable, Interventional, and Treatment
In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will conduct a pilot study for the purposes of testing equipment, finalizing data collection protocol, and training study personnel before conducting the full-scale trial.
In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will conduct a pilot study for the purposes of testing equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial. Only feasibility data will be collected and reported for this pilot study.
The full-scale trial, titled as "Patient response to spinal manipulation" (Trial registration: NCT01670292 on clinicaltrials.gov), is the Project 1 of the Developmental Center for Clinical and Translational Science in Chiropractic (Award No. U19AT004663).
In the current pilot study, we test how research clinicians can treat patients under study measurement conditions and with equipment resulting in modified treatment procedures. This pilot study will also test spinal stiffness using 3 different methods on 2 study visits. We will also assess the function of low back muscles during standing and while bending forward on 2 visits. These measurements include placing sensors on the back with tape and measuring the electrical activity of low back muscles. Participants with low back pain are treated with side-lying high-velocity low-amplitude spinal manipulation by experienced research clinicians who are doctors of chiropractic. Specifically, we will recruit 6 participants who are 21 - 64 years old and have had low back pain for at least 3 months. Each participant will attend 1 baseline visit, 1 enrollment visit, and 4 treatment visits over a period of approximately 4 weeks. Following the baseline visit, participant eligibility will be determined. The enrollment visit will be scheduled on the same day as the first treatment visit. The following feasibility data will be collected:
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Palmer College of Chiropractic is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
High velocity, low amplitude lumbo-pelvic manipulation
Other: HVLA-SM
High velocity, low amplitude spinal manipulation
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study
Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.
Time frame: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.
Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.
Time frame: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits
| Milestone | HVLA-SM |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.
| participants | Feasibility Outcomes |
|---|---|
| # Participants Recruited | 19 |
| # Participants Consented | 9 |
| # Participants Enrolled | 6 |
| # Participants Completed | 6 |
Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.
| months | Feasibility Outcomes |
|---|---|
| Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration. | 4 |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HVLA-SM | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | HVLA-SM |
|---|---|
| Mean | 53 ± 10.5 |
| Sex: Female, Male(Participants) | HVLA-SM |
|---|---|
| Female | 1 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | HVLA-SM |
|---|---|
| White | 5 |
| Other | 1 |
| Region of Enrollment(participants) | HVLA-SM |
|---|---|
| United States | 6 |
Plan to share: No — Feasibility/pilot study
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Palmer College of Chiropractic