Low Back PainINSIGHTNCT02409797
measurINg forceS durInG cHiropractic Treatment
A study testing Flexion-Distraction (non-thrust) spinal manipulation in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.
Trial summary
The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during the delivery of a specific, manually based chiropractic treatment for participants with low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Flexion-Distraction (non-thrust) spinal manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to demonstrate the necessary abilities (English language, literacy) needed to provide informed consent without the assistance of another person (e.g., a proxy, spouse, family member or other support person)
- Self-reported low back pain (acute, subacute or chronic) at the time of examination and enrollment
Who cannot join
- Weight > 300lbs
- Spinal Pathology or conditions contraindicating study procedures or compromising participant safety
- Inflammatory arthropathy involving the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
- Spinal fracture in the past 6 months
- Other conditions requiring referral (e.g. self-reporting alcohol/substance dependence or abuse, unstable spinal segments, and cauda equina syndrome)
- Pregnant or planning to become pregnant within the next 5 weeks
Show all 14Show fewer
- Unable to tolerate study procedures safely
- Altered Mental Capacity
- Sensitivity to adhesives used in the study
- Uncontrolled hypertension
- Co-morbidity requiring simultaneous clinical management that compromises ability to deliver study procedures or assess the participant's heath status or poses as a scheduling burden
- Retention of legal advice or seeking a health-related insurance claim
- Compliance concerns (e.g. scheduling conflicts, moving from the quad city area, unwilling to undergo required study procedures or receive treatment from study doctor(s))
- Quebec Task Force Classification of 10 or 11: (chronic pain syndrome, visceral/infectious source of LBP)
Trial locations and contacts
1 site in 1 country.
United States1 site
Palmer Center for Chiropractic Research
Davenport, Iowa, 52803
About this study
Official title: measurINg forceS durInG cHiropractic Treatment (INSIGHT): A Single-Arm Clinical Case Series
The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during the delivery of a specific, manually based chiropractic treatment for participants with low back pain.
Read the detailed description
Low back pain (LBP) is a well-recognized health problem. One common manual therapy available for the treatment of LBP is spinal manipulation (SM), which can be separated into 2 categories: High-Velocity Low-Amplitude (thrust) and Low-Velocity (non-thrust) SM according to their force-delivery profiles. One commonly utilized non-thrust SM technique is the Flexion-Distraction procedure. Several studies have reported manually applied forces during thrust SM; however, the forces used during non-thrust SM, specifically those used with Flexion-Distraction treatment are still unknown. The results of this pilot study will provide preliminary information on treatment forces and sample size justification for future full-scale trials, while also ascertaining the feasibility of the study protocol and patient recruitment methods for such trials.
- Conditions
- Low Back Pain
- Being tested
- Flexion-Distraction (non-thrust) spinal manipulation
- 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.
Flexion-Distraction (non-thrust) spinal manipulationOther
Enrolled participants will receive chiropractic care over a 2-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach and treatment frequency based upon a participant's clinical presentation. If provided, treatments will include low-velocity (non-thrust) spinal manipulation using the Flexion-Distraction procedure. Recommendations for exercise, lifestyle modifications, or other therapies may also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Flexion-Distraction spinal manipulation | Experimental | Participants will receive Flexion-Distraction treatment from a licensed doctor of chiropractic. During the procedure the participant lies prone on a specially designed treatment table. The table is equipped with a movable lower body section, which can be directed by the study doctor to lower the participants legs, move them from side to side, or in a traction motion. Table movements can occur in combination with other motions, depending on the diagnosis and characteristics specific to the participant's condition. During this procedure, the doctor will also touch the lower or upper part of the participants back or neck with their hands to direct treatment toward specific spinal regions. Receives: Other: Flexion-Distraction (non-thrust) spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traction forces
We will measure traction forces delivered to the participant by the clinician during all study visits over a 2-week time period. Traction forces will be summarized descriptively with means and standard deviations. Primary outcomes will compare changes in traction forces between the baseline and final treatment visit at 2 weeks.
Measured: Baseline and 2 weeks
Secondary outcomes (1)
Pain Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used to assess the participant's current back pain level and their average back pain levels over the past 24hrs and week. Participants will be asked to rate their level of pain on a 100 millimeter continuum horizontal scale with no pain and worst imaginable pain anchors.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palmer College of Chiropractic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert D Vining, DC, Principal investigator, Palmer Center for Chiropractic Research (PCCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409797
- Sponsor's protocol ID
- INSIGHT-2015V164
- Acronym
- INSIGHT
- Status last verified
- Mar 2017
- First submitted
- 12 Mar 2015
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Feasibility/pilot study
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- measurINg forceS durInG cHiropractic Treatment (INSIGHT): A Single-Arm Clinical Case Series
- ClinicalTrials.gov ID
- NCT02409797
- Acronym / sponsor ID
- INSIGHT / INSIGHT-2015V164
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Palmer College of ChiropracticUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during the delivery of a specific, manually based chiropractic treatment for participants with low back pain.
Detailed description
Low back pain (LBP) is a well-recognized health problem. One common manual therapy available for the treatment of LBP is spinal manipulation (SM), which can be separated into 2 categories: High-Velocity Low-Amplitude (thrust) and Low-Velocity (non-thrust) SM according to their force-delivery profiles. One commonly utilized non-thrust SM technique is the Flexion-Distraction procedure. Several studies have reported manually applied forces during thrust SM; however, the forces used during non-thrust SM, specifically those used with Flexion-Distraction treatment are still unknown. The results of this pilot study will provide preliminary information on treatment forces and sample size justification for future full-scale trials, while also ascertaining the feasibility of the study protocol and patient recruitment methods for such trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexion-Distraction spinal manipulation | Experimental | Other: Flexion-Distraction (non-thrust) spinal manipulationParticipants will receive Flexion-Distraction treatment from a licensed doctor of chiropractic. During the procedure the participant lies prone on a specially designed treatment table. The table is equipped with a movable lower body section, which can be directed by the study doctor to lower the participants legs, move them from side to side, or in a traction motion. Table movements can occur in combination with other motions, depending on the diagnosis and characteristics specific to the participant's condition. During this procedure, the doctor will also touch the lower or upper part of the participants back or neck with their hands to direct treatment toward specific spinal regions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to demonstrate the necessary abilities (English language, literacy) needed to provide informed consent without the assistance of another person (e.g., a proxy, spouse, family member or other support person)
- Self-reported low back pain (acute, subacute or chronic) at the time of examination and enrollment
Key exclusion criteria (14 listed)
- Weight > 300lbs
- Spinal Pathology or conditions contraindicating study procedures or compromising participant safety
- Inflammatory arthropathy involving the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
- Spinal fracture in the past 6 months
- Other conditions requiring referral (e.g. self-reporting alcohol/substance dependence or abuse, unstable spinal segments, and cauda equina syndrome)
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 |
|---|---|---|
| Flexion-Distraction (non-thrust) spinal manipulationEnrolled participants will receive chiropractic care over a 2-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach and treatment frequency based upon a participant's clinical presentation. If provided, treatments will include low-velocity (non-thrust) spinal manipulation using the Flexion-Distraction procedure. Recommendations for exercise, lifestyle modifications, or other therapies may also be provided. | Other | Flexion-Distraction spinal manipulation |
Primary outcome
Traction forces
Time frame: Baseline and 2 weeks
We will measure traction forces delivered to the participant by the clinician during all study visits over a 2-week time period. Traction forces will be summarized descriptively with means and standard deviations. Primary outcomes will compare changes in traction forces between the baseline and final treatment visit at 2 weeks.
1 secondary outcome
Pain Visual Analog Scale (VAS)
Time frame: Baseline and 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- 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.
Robert D Vining, DC principal investigator
Palmer Center for Chiropractic Research (PCCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexion-Distraction (non-thrust) spinal manipulation 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 2 inclusion and 14 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 30 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Traction forces (time frame: Baseline and 2 weeks). 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 30 Mar 2017.