Low Back PainPRiSMNCT01670292

Patient Response to Spinal Manipulation

A study testing HVLA-SM in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: HVLA-SM
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: Sep 2012to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

NRS score, AVERAGE within the past 24 hours
Must be ≥4 at the phone screen or baseline 1 visit
Must be ≥2 at phone screen, baseline 1 and baseline 2 visits
Roland Morris Disability ≥6
Age 21-65
Signed informed consent document
Chronic (12+ weeks) low back pain

Who cannot join

Compliance concerns
No manipulable lesion in L1-L5 or SI joints
The absence of typical palpatory characteristics as well as the absence of a global assessment that would indicate that spinal manipulation is likely to generate a positive therapeutic effect, even without the presence of standard palpatory findings
Ongoing treatment for low back pain by outside provider
Comorbid conditions
Serious concomitant illness

Show all 46Show fewer

Inflammatory or destructive spinal tissue change
Ankylosing Spondylytis
Fibromyalgia
Rheumatoid Arthritis
Confirmed or suspected disc herniation with neurological signs
Neuromuscular disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis
Spinal surgery <6 months
Suspicion of drug or alcohol dependence or abuse
Uncontrolled hypertension
Lower extremity peripheral arterial disease
Undetermined, infections or visceral source of low back pain
Other comorbid conditions prohibiting treatment and/or testing
Safety concerns
Bleeding disorders
Contraindications to High Velocity Low Amplitude Spinal Manipulation
Inability to tolerate or obtain positon for flexion-relaxation test without condition aggravation
Inability to tolerate or perform/receive any study procedure without condition aggravation
Quebec Task Force (QTF) criterion 4-11:
QTF 4: Pain + radiation to upper/lower limb with neurologic signs
QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram
QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques
QTF 7: Spinal Stenosis
QTF 8: Postsurgical status, 1-6 months after intervention
QTF 9: Postsurgical status, >6 months after intervention
QTF 10: Chronic pain syndrome
QTF 11: Other diagnoses
Pregnancy
Pacemaker or defibrillator
Inability to read or verbally comprehend English
Joint replacement
Use of spinal manipulation within past 4 weeks
Sensitivity to adhesive
Diagnostic procedures other than x-ray/UA necessary
BDI-II ≥29
Retention of legal advice and open or pending case related to low back pain
BMI ≥40
Unwilling to have low back and wrist shaved
Moving from Quad Cities area within next 8 weeks
Unwilling to postpone treatments for low back pain from another provider
Seeking or receiving compensation for any disability

Trial locations and contacts

1 site in 1 country.

United States1 site

Palmer College of Chiropractic
Davenport, Iowa, 52803

Other trials in United States

About this study

This is a biomechanical study which is Project 1 in the Developmental Center for Clinical and Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01; principal investigator Christine Goertz, DC, PhD). This study is designed to monitor both physiological and patient self-report outcome variables. In addition, as there is little quantitative information on Spinal Manipulation Technique procedures reported in clinical trials, the study is designed to collect preliminary kinetic measures of the spinal manipulation technique delivery (i.e. force-time profiles).

Read the detailed description

Participants with narrowly defined chronic low back pain will be included in this study. Each participant will be treated 12 times over the course of 6 weeks. The following data will be collected: participant characteristics that may predict outcome or be modifiers of force used by provider (gender, age, height, weight, and Body Mass Index); spinal segment load during the pre-load and thrusting phases (force and moment in the pre-load phase, peak load, and loading rate); physiological measures (posterior-anterior global stiffness and flexion-relaxation); patient-centered outcomes of back pain and function; and adverse events.

Study participants (n= 80) will be recruited from the Quad Cities metro area. A team of experienced chiropractic clinicians working at the Palmer Center for Chiropractic Research will treat study participants. Each of the study participants will receive 2 High Velocity Low Amplitude Spinal Manipulation treatment visits per week over a 6 week period. The physiological assessments will be performed immediately before and after Spinal Manipulation delivery during treatment visits 1, 5 \& 12 (6 sets of assessments in total). During these same treatment visits, we will also capture the kinetic measures during Spinal Manipulation delivery for spinal segment load analysis. Participant patient-centered outcomes will be measured at baseline 1, and treatment visits 6 and 13. For simplicity, data collection time points will be named as baseline, after 2 weeks, and after 6 weeks.

Conditions: Low Back Pain
Being tested: HVLA-SM
Keywords: Low Back Pain
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HVLA-SMOther
High Velocity Low Amplitude Spinal Manipulation

Study groups in NCT01670292
Study group	Role	What they receive
Experimental: HVLA-SM	Other	Experimental High Velocity Low Amplitude Spinal Manipulation Receives: Other: HVLA-SM

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)
VAS - Visual Analog Scale - Scale: 0-100 mm (anchors: 0 mm = No Pain, 100 mm = Worst Imaginable Pain). VAS Interpretation: A higher score indicates greater pain intensity. In this study, improvement of 30% from the baseline value was considered clinically significant.
RMDQ - Roland Morris disability questionnaire - Scale: 0 (no disability) to 24 (maximum disability). RMDQ Interpretation: Greater levels of disability are reflected by higher scores. In this study, improvement of 30% from the baseline value was considered clinically significant.
Measured: Baseline to 6 weeks
Lumbar-spine Stiffness (LSS)
LSS* contains 5 variables: global stiffness (GS, unit: Newton/mm) at L3 from 1) hand palpation 2) a hand-held device \& 3) an automated indenter device; global stiffness variation (GSV, unit: Newton/mm) between GS from L1 to L5 from 4) hand palpation \& 5) a hand-held device.
*LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.
Measured: Baseline, 2 weeks, 6 weeks
Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation
LSS contains 2 variables: Palpatory and Handheld device - normalized global stiffness variation (nGSV, unitless).
LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, lower than normal.
Measured: Baseline, 2 weeks, 6 weeks
Flexion-Relaxation Ratio (FRR)
FRR contains 4 variables, which are the average right and left back muscle FRR obtained using 1) maximum EMG during flexion, and 2) maximum EMG during extension to normalize EMG during full flexion; and asymmetry between the right and left back muscle FRRs using 3) maximum EMG during flexion, and 4) maximum EMG during extension to normalize EMG during full flexion
FRR Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.
Measured: Baseline, 2 weeks, 6 weeks

Secondary outcomes (7)

Kinetic Measure - Spinal Segment Load (SSL) Force
SSL* contains variables: maximum amplitude (Newton) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).
*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.
Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
Measured: 6 weeks
Kinetic Measure - Spinal Segment Load (SSL) Moment
SSL* contains variables: maximum amplitude (Newton*Meter for moment) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).
*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.
Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
Measured: 6 weeks
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force
SSL* contains variables: rate of loading for force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).
*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.
Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
Measured: 6 weeks
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment
SSL* contains variables: rate of loading for moment in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).
*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.
Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.
Measured: 6 weeks
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale
1. The questionnaire contains 7 PROMIS-29 specific items: Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction with Participation in Social Role (anchors: 1= 'Not at all', 5= 'Very much', higher score is worse).
Each PROMIS-29 specific item is reported in raw score (4-20) and scored in T-score (T), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for a population.
On the T-score metric \& interpretation:
- A score of 40 is one SD lower than the mean of the reference population.
- A score of 60 is one SD higher than the mean of the reference population.
- For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
Measured: Baseline, 2 weeks, 6 weeks
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS
1. The PROMIS questionnaire contains 1 PROMIS global item: Pain NRS, Scale: 0-10 (anchors: 0 = No Pain, 10 = Worst Imaginable Pain, higher score is worse). The PROMIS global item is not scored but reported in raw score.
Measured: Baseline, 2 weeks, 6 weeks
Bothersomeness
Question asked of participants: "During the past week, how bothersome have each of the following symptoms been?" The bothersomeness questionnaire contains two items: a) low back pain \& b) leg pain (sciatica).
Scale: 0-10 (anchors: 0 = Not at all bothersome, 10 = Extremely bothersome)
Measured: Baseline, 2 weeks, 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Jun 2014

First posted22 Aug 2012 (estimated)
Study startSep 2012
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01670292
Sponsor's protocol ID: PRiSM Study
Other IDs: U19AT004663
Acronym: PRiSM
Status last verified: Oct 2017
First submitted: 2 Aug 2012
Last updated: 5 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: 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.

Publications

Xia T, Wilder DG, Gudavalli MR, DeVocht JW, Vining RD, Pohlman KA, Kawchuk GN, Long CR, Goertz CM. Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain. BMC Complement Altern Med. 2014 Aug 8;14:292. doi: 10.1186/1472-6882-14-292.
PubMed 25106673
Minkalis AL, Vining RD. What is the pain source? A case report of a patient with low back pain and bilateral hip osteonecrosis. J Can Chiropr Assoc. 2015 Sep;59(3):300-10.
PubMed 26500365
Xia T, Long CR, Vining RD, Gudavalli MR, DeVocht JW, Kawchuk GN, Wilder DG, Goertz CM. Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation. BMC Complement Altern Med. 2017 Jun 9;17(1):303. doi: 10.1186/s12906-017-1821-1.
PubMed 28599647

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Response to Spinal Manipulation
ClinicalTrials.gov ID: NCT01670292
Acronym / sponsor ID: PRiSM / PRiSM Study
Conditions: Low Back Pain
Keywords: Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Palmer College of ChiropracticUniversity, hospital or other
Collaborators: University of Iowa, National Center for Complementary and Integrative Health (NCCIH)
Study start: Sep 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 22 Aug 2012 (estimated)
Results: Posted 5 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental: HVLA-SM	Other	Other: HVLA-SMExperimental High Velocity Low Amplitude Spinal Manipulation

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

NRS score, AVERAGE within the past 24 hours
Must be ≥4 at the phone screen or baseline 1 visit
Must be ≥2 at phone screen, baseline 1 and baseline 2 visits
Roland Morris Disability ≥6
Age 21-65

Key exclusion criteria (46 listed)

Compliance concerns
No manipulable lesion in L1-L5 or SI joints
The absence of typical palpatory characteristics as well as the absence of a global assessment that would indicate that spinal manipulation is likely to generate a positive therapeutic effect, even without the presence of standard palpatory findings
Ongoing treatment for low back pain by outside provider
Comorbid conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HVLA-SMHigh Velocity Low Amplitude Spinal Manipulation	Other	Experimental: HVLA-SM

Primary outcome

Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)
Time frame: Baseline to 6 weeks
VAS - Visual Analog Scale - Scale: 0-100 mm (anchors: 0 mm = No Pain, 100 mm = Worst Imaginable Pain). VAS Interpretation: A higher score indicates greater pain intensity. In this study, improvement of 30% from the baseline value was considered clinically significant. RMDQ - Roland Morris disability questionnaire - Scale: 0 (no disability) to 24 (maximum disability). RMDQ Interpretation: Greater levels of disability are reflected by higher scores. In this study, improvement of 30% from the baseline value was considered clinically significant.
Lumbar-spine Stiffness (LSS)
Time frame: Baseline, 2 weeks, 6 weeks
LSS* contains 5 variables: global stiffness (GS, unit: Newton/mm) at L3 from 1) hand palpation 2) a hand-held device \& 3) an automated indenter device; global stiffness variation (GSV, unit: Newton/mm) between GS from L1 to L5 from 4) hand palpation \& 5) a hand-held device. *LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.
Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation
Time frame: Baseline, 2 weeks, 6 weeks
LSS contains 2 variables: Palpatory and Handheld device - normalized global stiffness variation (nGSV, unitless). LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, lower than normal.
Flexion-Relaxation Ratio (FRR)
Time frame: Baseline, 2 weeks, 6 weeks
FRR contains 4 variables, which are the average right and left back muscle FRR obtained using 1) maximum EMG during flexion, and 2) maximum EMG during extension to normalize EMG during full flexion; and asymmetry between the right and left back muscle FRRs using 3) maximum EMG during flexion, and 4) maximum EMG during extension to normalize EMG during full flexion FRR Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.

7 secondary outcomes

Kinetic Measure - Spinal Segment Load (SSL) Force
Time frame: 6 weeks
Kinetic Measure - Spinal Segment Load (SSL) Moment
Time frame: 6 weeks
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force
Time frame: 6 weeks
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment
Time frame: 6 weeks
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale
Time frame: Baseline, 2 weeks, 6 weeks
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS
Time frame: Baseline, 2 weeks, 6 weeks
Bothersomeness
Time frame: Baseline, 2 weeks, 6 weeks

Results and safety

Results posted to the registry on 5 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: HVLA-SM	82	68

Primary outcome: Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)

Time frame: Baseline to 6 weeks. Mean (95% Confidence Interval). Unit: units on a scale (see description above)

Measure	Experimental: HVLA-SM n = 82
Mean Reduction in VAS score (mm)	20.1 (14.1 to 26.1)
Mean Reduction in RMDQ score	4.8 (3.7 to 5.8)

Population analysed: 82 and 68 participants completed at baseline and after 6 weeks, respectively. Data from all participants (n=82) were used in statistical analysis. The reported data represents the mean change from baseline to week 6.

Primary outcome: Lumbar-spine Stiffness (LSS)

Time frame: Baseline, 2 weeks, 6 weeks. Mean (Standard Deviation). Unit: N/mm

Measure	HVLA-SM at Baseline n = 82	HVLA-SM After 2 Weeks n = 71	HVLA-SM After 6 Weeks n = 68
LSS - Palpatory - GS (N/mm) at L3	4.8 (1.8)	4.3 (1.8)	4.2 (1.3)
LSS - Hand-held - GS (N/mm) at L3	7.7 (2.1)	7.5 (1.8)	7.6 (2.2)
LSS - Automated - GS (N/mm) at Ant	5.2 (1.5)	5.3 (1.4)	5.3 (1.5)
LSS - Palpatory - GSV (N/mm)	2.3 (1.5)	2.0 (1.1)	1.9 (1.1)
LSS - Hand-held - GSV (N/mm)	2.3 (1.3)	2.1 (1.1)	2.1 (1.3)

Population analysed: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. The number of observations at each of the 3 time points for individual measures is equal to or lower than these numbers due to missing data.

Primary outcome: Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation

Time frame: Baseline, 2 weeks, 6 weeks. Mean (Standard Deviation). Unit: unitless

Measure	HVLA-SM at Baseline n = 82	HVLA-SM After 2 Weeks n = 71	HVLA-SM After 6 Weeks n = 68
LSS - Palpatory - nGSV	0.5 (0.2)	0.5 (0.2)	0.5 (0.2)
LSS - Hand-held - nGSV	0.3 (0.1)	0.3 (0.1)	0.3 (0.1)

Primary outcome: Flexion-Relaxation Ratio (FRR)

Time frame: Baseline, 2 weeks, 6 weeks. Mean (Standard Deviation). Unit: ratio

Measure	HVLA-SM at Baseline n = 82	HVLA-SM After 2 Weeks n = 71	HVLA-SM After 6 Weeks n = 68
Flexion FRR	4.7 (3.7)	5.8 (5.4)	5.5 (5.6)
Extension FRR	9.2 (9.5)	10.4 (11.6)	9.4 (10.5)
Asymmetry in flexion FRR	1.5 (0.5)	1.4 (0.5)	1.4 (0.4)
Asymmetry in extension FRR	1.4 (0.7)	1.4 (0.4)	1.4 (0.5)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: HVLA-SM*	0 of 82 (0%)	74 of 82 (90.2%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25106673Xia T, Wilder DG, Gudavalli MR, DeVocht JW, Vining RD, Pohlman KA, Kawchuk GN, Long CR, Goertz CM. Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain. BMC Complement Altern Med. 2014 Aug 8;14:292. doi: 10.1186/1472-6882-14-292.
Background: PubMed 26500365Minkalis AL, Vining RD. What is the pain source? A case report of a patient with low back pain and bilateral hip osteonecrosis. J Can Chiropr Assoc. 2015 Sep;59(3):300-10.
Derived from this study: PubMed 28599647Xia T, Long CR, Vining RD, Gudavalli MR, DeVocht JW, Kawchuk GN, Wilder DG, Goertz CM. Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation. BMC Complement Altern Med. 2017 Jun 9;17(1):303. doi: 10.1186/s12906-017-1821-1.
Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back painLink provided by the sponsor.
What is the pain source? A case report of a patient with low back pain and bilateral hip osteonecrosis.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ting Xia, PhD principal investigator

Palmer College of Chiropractic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HVLA-SM in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ) (time frame: Baseline to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01670292, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.