Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U19AT004137 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The long-term goal for this study is to understand the physiological mechanisms of various forms of spinal manipulation in order to refine and improve this therapy for appropriately selected patients. The objective of this study is to assess the effects of high-velocity low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on three types of sensorimotor abilities in patients with low back pain.
In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will pursue the following specific aim: To determine the effects of 2 weeks (4 applications @ 2 per week) of HVLA-SM and LVVA-SM to the lumbo-pelvic region, compared to a control group receiving light effleurage and a sham mechanically assisted adjustment, on sensorimotor function as measured by: lumbo-pelvic repositioning ability, standing postural sway and response to sudden trunk loading;
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVLA-SM | Active Comparator | High velocity, low amplitude lumbo-pelvic manipulation |
|
| LVVA-SM | Active Comparator | Low velocity, variable amplitude lumbo-pelvic manipulation |
|
| Sham Intervention | Placebo Comparator | Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVLA-SM | Other | High velocity, low amplitude lumbo-pelvic manipulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postural Sway | Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction. | Baseline and 2 weeks |
| Postural Sway Speed | Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Sway Speed=overall center of pressure traveling distance divided by time. | Baseline and 2 weeks |
| Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL | Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure | Baseline and 2 weeks |
| Response to Sudden Load, Peak Muscle Response Per Side | Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae) | Baseline and 2 weeks |
| Response to Sudden Load Response Times | Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine Goertz, DC, PhD | Palmer College of Chiropractic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmer College of Chiropractic | Davenport | Iowa | 52803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21708042 | Background | Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161. | |
| 25344427 | Background | Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406. |
Not provided
Not provided
Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants with acute, subacute, or chronic low back pain were recruited from local communities.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HVLA-SM | High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation |
| FG001 | LVVA-SM | Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation |
| FG002 | Sham Intervention | Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HVLA-SM | High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation |
| BG001 | LVVA-SM | Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postural Sway | Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction. | Posted | Mean | 95% Confidence Interval | mm | Baseline and 2 weeks |
|
2 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.
*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HVLA-SM* | High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spine-related pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Goertz, DC, PhD, Principal Investigator | Palmer College of Chiropractic | (563) 884-5150 | christine.goertz@palmer.edu |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LVVA-SM |
| Other |
Low velocity, variable amplitude lumbo-pelvic manipulation |
|
| Sham Intervention | Other | 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation |
|
|
| Baseline and 2 weeks |
| 23997245 | Background | Vining R, Potocki E, Seidman M, Morgenthal AP. An evidence-based diagnostic classification system for low back pain. J Can Chiropr Assoc. 2013 Sep;57(3):189-204. |
| 26319101 | Result | Goertz CM, Xia T, Long CR, Vining RD, Pohlman KA, DeVocht JW, Gudavalli MR, Owens EF Jr, Meeker WC, Wilder DG. Effects of spinal manipulation on sensorimotor function in low back pain patients--A randomised controlled trial. Man Ther. 2016 Feb;21:183-90. doi: 10.1016/j.math.2015.08.001. Epub 2015 Aug 8. |
| 25455834 | Result | Vining RD, Potocki E, McLean I, Seidman M, Morgenthal AP, Boysen J, Goertz C. Prevalence of radiographic findings in individuals with chronic low back pain screened for a randomized controlled trial: secondary analysis and clinical implications. J Manipulative Physiol Ther. 2014 Nov-Dec;37(9):678-87. doi: 10.1016/j.jmpt.2014.10.003. Epub 2014 Nov 1. |
| BG002 | Sham Intervention | Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Sham Intervention | Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation |
|
|
| Primary | Postural Sway Speed | Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Sway Speed=overall center of pressure traveling distance divided by time. | Posted | Mean | 95% Confidence Interval | mm/s | Baseline and 2 weeks |
|
|
|
| Primary | Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL | Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure | Posted | Mean | 95% Confidence Interval | mm | Baseline and 2 weeks |
|
|
|
| Primary | Response to Sudden Load, Peak Muscle Response Per Side | Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae) | Posted | Mean | 95% Confidence Interval | % muscle response | Baseline and 2 weeks |
|
|
|
| Primary | Response to Sudden Load Response Times | Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae) | Posted | Mean | 95% Confidence Interval | ms | Baseline and 2 weeks |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 50 |
| 74 |
| EG001 | LVVA-SM* | Low velocity, variable amplitude lumbo-pelvic manipulation LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation | 0 | 74 | 0 | 74 | 57 | 74 |
| EG002 | Sham Intervention* | Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation | 0 | 73 | 0 | 73 | 46 | 73 |
| Spine-related pain with radiation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Extremity pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| General stiffness/tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Transient muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tenderness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasm/cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tiredness/fatigue | General disorders | Systematic Assessment |
|
| Dizziness/imbalance/vertigo | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Sinus congestion/respiratory symptoms/allergy | General disorders | Systematic Assessment |
|
| Migraine | General disorders | Systematic Assessment |
|
| Insect bite | General disorders | Systematic Assessment |
|
| Gastrointestinal symptoms | General disorders | Systematic Assessment |
|
| Tooth/facial pain | General disorders | Systematic Assessment |
|
| Numbness/tingling | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Postural Sway_Sway speed - Soft (mm/s) |
|
| RTSL_Norm. peak muscle response - R (%) |
|
| RTSL_Response start time R (ms) |
|
| RTSL_Peak response time - L (ms) |
|
| RTSL_Peak response time - R (ms) |
|