Low Back PainPRiSMNCT01562756
Patient Response to Spinal Manipulation - Pilot Study
A study testing HVLA-SM in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-65
- Signed informed consent document
- Chronic (12+ weeks) low back pain (LBP)
- Average pain within past 24 hours ≥ 2/10 at phone screen, baseline visit 1, and baseline visit 2
Who cannot join
- Compliance concerns such as refusal to shave body hair
- No manipulable lesion in L3, L4, 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)
- Comorbid Conditions:
- Serious Contaminant Illness
- Inflammatory or Destructive Spinal Tissue change
- Ankylosing Spondylitis
Show all 38Show fewer
- Fibromyalgia
- Rheumatoid Arthritis
- Neuromuscular Disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis)
- Spinal Surgery < 6 mo
- Suspicion of drug or alcohol abuse
- Uncontrolled hypertension
- Peripheral Arterial Disease
- Undetermined, infectious or visceral source of LBP
- Other comorbid conditions prohibiting treatment and/or testing
- Safety Concerns
- Bleeding Disorders
- Contraindications to HVLA-SM
- Quebec Task Force (QTF) criterion 4-11:
- QTF 4: Pain + radiation to upper/lower limb with 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
- Sensitivity to adhesive
- Additional diagnostic procedures other than x-ray necessary
- BDI-II > 29
- Retention of legal advice and open or pending case related to LBP
- BMI > 40
- Unwilling to have low back and wrist shaved
- 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
About this study
Official title: Pilot for Patient Response to Spinal Manipulation (PRiSM)
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.
Read the detailed description
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
- Conditions
- Low Back Pain
- Being tested
- HVLA-SM
- 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 group | Role | What they receive |
|---|---|---|
| HVLA-SM | Experimental | High velocity, low amplitude lumbo-pelvic manipulation Receives: Other: HVLA-SM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
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.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palmer College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Iowa
- Responsible party
- Sponsor
- Investigators
- Ting Xia, PhD, Principal investigator, Palmer College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562756
- Sponsor's protocol ID
- PRiSM Pilot
- Other IDs
- U19AT004663
- Acronym
- PRiSM
- Status last verified
- May 2017
- First submitted
- 22 Mar 2012
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Feasibility/pilot study
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot for Patient Response to Spinal Manipulation (PRiSM)
- ClinicalTrials.gov ID
- NCT01562756
- Acronym / sponsor ID
- PRiSM / PRiSM Pilot
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Palmer College of ChiropracticUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Iowa
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HVLA-SM | Experimental | Other: HVLA-SMHigh velocity, low amplitude lumbo-pelvic manipulation |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21-65
- Signed informed consent document
- Chronic (12+ weeks) low back pain (LBP)
- Average pain within past 24 hours ≥ 2/10 at phone screen, baseline visit 1, and baseline visit 2
Key exclusion criteria (38 listed)
- Compliance concerns such as refusal to shave body hair
- No manipulable lesion in L3, L4, 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)
- Comorbid Conditions:
- Serious Contaminant Illness
- Inflammatory or Destructive Spinal Tissue change
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 | HVLA-SM |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Feasibility/pilot study
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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 4 inclusion and 38 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 31 Jul 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 31 Jul 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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2017.