Low Back PainTLFMNCT03916705
Thoraco-Lumbar Fascia Mobility
A study testing High Velocity Low amplitude spinal manipulation (HVLA-SM) in people with Low Back Pain, run by Palmer College of Chiropractic at 1 site in United States.
Trial summary
The purpose of the Thoraco-Lumbar Fascial Mobility (TLFM) study is to use ultrasound to measure the movement of connective tissue in the low back area of individuals with chronic low back pain (lasting more than 1 year). Read more about this study
- 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?
- High Velocity Low amplitude spinal manipulation (HVLA-SM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 30 Apr 2021
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between 21 and 65 years
- LBP of ≥ 1-yr duration with at least ½ of days with pain over the prior 6-months
- Able to understand study procedures and willing to sign informed consent document
- Willing to forgo any manual therapy for LBP for the initial 4-week study period
- Willing to forgo any manual therapy for LBP other than study treatments during the 8-week treatment period
- Able to tolerate and safely receive study procedures
Who cannot join
- Chiropractic care or other manual therapy for at least 90 days prior to baseline visit
- Unable to visualize necessary tissue layers using musculoskeletal ultrasound
- Weight above 350 lbs
- Unable to tolerate or safely receive study procedures
- Need for referral
- Unable or unwilling to comply with study procedures
Show all 10Show fewer
- Current or planned pregnancy (self-reported) within the study timeframe
- Any prior surgery to the thoracolumbar region
- Needing a proxy
- Connective tissue disorder such as Marfan and Ehlers-Danlos syndrome
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: Thoraco-Lumbar Fascia Mobility in Persons With Chronic Low Back Pain
The purpose of the Thoraco-Lumbar Fascial Mobility (TLFM) study is to use ultrasound to measure the movement of connective tissue in the low back area of individuals with chronic low back pain (lasting more than 1 year). This study will compare baseline measurements, measurements after a single high velocity low amplitude spinal manipulation (HVLA-SM) and after a course of up to 16 HVLA-SM.
Read the detailed description
The investigators will conduct a single arm pilot (proof-of-concept) clinical trial. Approximately 30 participants with self-reported chronic low-back pain (LBP), defined as pain for ≥ 1-year in duration and pain on at least ½ of the days in the past 6-months, will be enrolled.
This trial will consist of two separate enrollment phases. Phase 1 consists of enrollment at baseline followed by 3 separate ultrasound measurements. Phase 1 ends after a 4-week no treatment run-in phase.
Phase 2 begins twice-weekly HVLA-SM treatments to the thoracolumbar region for 8-weeks. Two ultrasound imaging evaluations will occur at visit 1 (pre and post-treatment). Pre-treatment ultrasound evaluations will be obtained at 4-weeks and 8-weeks.
The primary outcome is shear strain (adjacent tissue layer mobility measured with ultrasound) at the level of the lumbar L2-L3 vertebrae bilaterally. Ultrasound measures will be obtained with a Terason t3000 system using a 12L5 linear array probe with 10 MHz setting. Because shear strain may differ between sexes, we will attempt to recruit equal numbers of male and female participants.
- Conditions
- Low Back Pain
- Being tested
- High Velocity Low amplitude spinal manipulation (HVLA-SM)
- Keywords
- Back Pain, Ultrasound, Fascia
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Velocity Low amplitude spinal manipulation (HVLA-SM)Other
HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.
| Study group | Role | What they receive |
|---|---|---|
| single study arm | Other | All enrolled participants will undergo ultrasound evaluation and chiropractic low back spinal manipulation treatment. Receives: Other: High Velocity Low amplitude spinal manipulation (HVLA-SM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound
Short and longer-term changes in shear-strain will be studied by comparing between ultrasound recordings obtained at baseline and between measurements obtained at baseline and after 4-weeks
Measured: Short term change (Baseline), longer-term change (4 weeks)
Investigate changes in thoracolumbar fascia movement (called shear-strain) using ultrasound after high-velocity low-amplitude spinal manipulation
Changes in shear-strain measures associated with high-velocity low-amplitude spinal manipulation will be assessed at 3 separate time points.
Measured: 4-weeks, 8-weeks, 12 weeks
Examine differences in thoracolumbar movement (called shear-strain) using ultrasound. Measurements will be obtained in relaxed and active muscle contraction states
Compare thoracolumbar shear strain during relaxed passive flexion with active paraspinal contraction during passive flexion.
Measured: Baseline
Secondary outcomes (6)
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions on pain intensity
Worst, average, and current pain intensity measured on a self-reported 5-point numerical rating scale. Lower scores indicate lower pain
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions of pain interference
Pain interference measured on a self-reported 4-point numerical rating scale. The scale ranges from 4-20. Lower scores indicate higher pain interference.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Roland Morris Disability Questionnaire (RMDQ)
A 24-item self-reported scale assessing low-back pain related disability. Scores range from 0-24 with higher scores indicating higher disability.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) nociceptive pain quality scale
A 5-item self-reported scale used to identify persons more likely to have nociceptive pain. The scale ranges from 5-25 with higher scores indicating nociceptive pain is more likely.
Measured: Baseline
Perceived Global Low Back Pain Improvement
A single question asking patients about their perceived improvement on a 7 point scale. Lower scores indicate greater improvement.
Measured: 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) neuropathic pain quality scale
A 5-item self-reported scale used to identify persons more likely to have neuropathic pain. The scale ranges from 5-25 with higher scores indicating neuropathic pain is more likely.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start9 Sep 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof of concept study evaluating potential mechanisms of high-velocity low-amplitude spinal manipulation
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palmer College of Chiropractic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Vinining, DC, DHSc, Principal investigator, Palmer College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916705
- Sponsor's protocol ID
- TLFM
- Acronym
- TLFM
- Status last verified
- May 2021
- First submitted
- 8 Apr 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a proof of concept study. No data will be available for sharing.
Publications
Vining R, Onifer SM, Twist E, Ziegler AM, Corber L, Long CR. Thoracolumbar fascia mobility and chronic low back pain: Phase 1 of a pilot and feasibility study assessing repeated measures and the influence of paraspinal muscle contraction. J Bodyw Mov Ther. 2023 Apr;34:19-27. doi: 10.1016/j.jbmt.2023.04.004. Epub 2023 Apr 6.
PubMed 37301552Vining R, Onifer SM, Twist E, Ziegler AM, Corber L, Long CR. Thoracolumbar fascia mobility and chronic low back pain: Phase 2 of a pilot and feasibility study including multimodal chiropractic care. Chiropr Man Therap. 2022 Oct 21;30(1):46. doi: 10.1186/s12998-022-00455-z.
PubMed 36271428
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoraco-Lumbar Fascia Mobility in Persons With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03916705
- Acronym / sponsor ID
- TLFM / TLFM
- Conditions
- Low Back Pain
- Keywords
- Back Pain, Ultrasound, Fascia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Palmer College of ChiropracticUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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 purpose of the Thoraco-Lumbar Fascial Mobility (TLFM) study is to use ultrasound to measure the movement of connective tissue in the low back area of individuals with chronic low back pain (lasting more than 1 year). This study will compare baseline measurements, measurements after a single high velocity low amplitude spinal manipulation (HVLA-SM) and after a course of up to 16 HVLA-SM.
Detailed description
The investigators will conduct a single arm pilot (proof-of-concept) clinical trial. Approximately 30 participants with self-reported chronic low-back pain (LBP), defined as pain for ≥ 1-year in duration and pain on at least ½ of the days in the past 6-months, will be enrolled.
This trial will consist of two separate enrollment phases. Phase 1 consists of enrollment at baseline followed by 3 separate ultrasound measurements. Phase 1 ends after a 4-week no treatment run-in phase.
Phase 2 begins twice-weekly HVLA-SM treatments to the thoracolumbar region for 8-weeks. Two ultrasound imaging evaluations will occur at visit 1 (pre and post-treatment). Pre-treatment ultrasound evaluations will be obtained at 4-weeks and 8-weeks.
The primary outcome is shear strain (adjacent tissue layer mobility measured with ultrasound) at the level of the lumbar L2-L3 vertebrae bilaterally. Ultrasound measures will be obtained with a Terason t3000 system using a 12L5 linear array probe with 10 MHz setting. Because shear strain may differ between sexes, we will attempt to recruit equal numbers of male and female participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of concept study evaluating potential mechanisms of high-velocity low-amplitude spinal manipulation
| Arm | Type | Receives |
|---|---|---|
| single study arm | Other | Other: High Velocity Low amplitude spinal manipulation (HVLA-SM)All enrolled participants will undergo ultrasound evaluation and chiropractic low back spinal manipulation treatment. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults between 21 and 65 years
- LBP of ≥ 1-yr duration with at least ½ of days with pain over the prior 6-months
- Able to understand study procedures and willing to sign informed consent document
- Willing to forgo any manual therapy for LBP for the initial 4-week study period
- Willing to forgo any manual therapy for LBP other than study treatments during the 8-week treatment period
Key exclusion criteria (10 listed)
- Chiropractic care or other manual therapy for at least 90 days prior to baseline visit
- Unable to visualize necessary tissue layers using musculoskeletal ultrasound
- Weight above 350 lbs
- Unable to tolerate or safely receive study procedures
- Need for referral
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 |
|---|---|---|
| High Velocity Low amplitude spinal manipulation (HVLA-SM)HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain. | Other | single study arm |
Primary outcome
Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound
Time frame: Short term change (Baseline), longer-term change (4 weeks)
Short and longer-term changes in shear-strain will be studied by comparing between ultrasound recordings obtained at baseline and between measurements obtained at baseline and after 4-weeks
Investigate changes in thoracolumbar fascia movement (called shear-strain) using ultrasound after high-velocity low-amplitude spinal manipulation
Time frame: 4-weeks, 8-weeks, 12 weeks
Changes in shear-strain measures associated with high-velocity low-amplitude spinal manipulation will be assessed at 3 separate time points.
Examine differences in thoracolumbar movement (called shear-strain) using ultrasound. Measurements will be obtained in relaxed and active muscle contraction states
Time frame: Baseline
Compare thoracolumbar shear strain during relaxed passive flexion with active paraspinal contraction during passive flexion.
6 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions on pain intensity
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questions of pain interference
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Roland Morris Disability Questionnaire (RMDQ)
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) nociceptive pain quality scale
Time frame: Baseline
Perceived Global Low Back Pain Improvement
Time frame: 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) neuropathic pain quality scale
Time frame: Baseline
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 4 May 2021.
- Derived from this study: PubMed 37301552Vining R, Onifer SM, Twist E, Ziegler AM, Corber L, Long CR. Thoracolumbar fascia mobility and chronic low back pain: Phase 1 of a pilot and feasibility study assessing repeated measures and the influence of paraspinal muscle contraction. J Bodyw Mov Ther. 2023 Apr;34:19-27. doi: 10.1016/j.jbmt.2023.04.004. Epub 2023 Apr 6.
- Derived from this study: PubMed 36271428Vining R, Onifer SM, Twist E, Ziegler AM, Corber L, Long CR. Thoracolumbar fascia mobility and chronic low back pain: Phase 2 of a pilot and feasibility study including multimodal chiropractic care. Chiropr Man Therap. 2022 Oct 21;30(1):46. doi: 10.1186/s12998-022-00455-z.
- Individual participant dataSharing planned: No. This is a proof of concept study. No data will be available for sharing.
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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 Vinining, DC, DHSc 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 High Velocity Low amplitude spinal manipulation (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 6 inclusion and 10 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 4 May 2021. 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?
Examine changes in thoracolumbar fascia movement (called shear-strain) using ultrasound (time frame: Short term change (Baseline), longer-term change (4 weeks)). The study lists 3 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 NCT03916705, which also lists 2 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 4 May 2021.