Patient Response to Spinal Manipulation - Pilot Study (PRiSM)
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|ClinicalTrials.gov Identifier: NCT01562756|
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Other: HVLA-SM||Not Applicable|
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:
- # of participants recruited
- # of participants consented
- # of participants enrolled
- # of participants who completed the study
- Total duration of the study from launch data to the final study visit
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot for Patient Response to Spinal Manipulation (PRiSM)|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
High velocity, low amplitude lumbo-pelvic manipulation
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 [ Time Frame: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits ]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.
- Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration. [ Time Frame: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562756
|United States, Iowa|
|Palmer College of Chiropractic|
|Davenport, Iowa, United States, 52803|
|Principal Investigator:||Ting Xia, PhD||Palmer College of Chiropractic|