Musculoskeletal PainNCT03940313
Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
An observational study of Musculoskeletal Pain and Low Back Pain, run by ProloAustin at 1 site in United States.
Trial summary
This is a prospective study on chronic low back pain patients aimed at investigating how findings on a physical examination and musculoskeletal ultrasound may correlate with myofascial damage in the lower back. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Low Back Pain, Myofascial Pain
- What is being tested?
- Prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 25 Feb 2022
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with chronic lower back pain that meet inclusion and exclusion criteria.
Who may be able to join
- Age > or = 18 years old
- Chronic lower back pain > or = 12 weeks duration
Who cannot join
- History of stroke preventing bilateral muscle strength testing
- History of scoliosis that may affect myofascial dynamics
- Acute radiculopathy/sciatica or pain that limits movement for physical examination
- Unable to lie prone for physical examination
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective study on chronic low back pain patients aimed at investigating how findings on a physical examination and musculoskeletal ultrasound may correlate with myofascial damage in the lower back. By comparing these findings with a control group and collecting follow up data on patients treated in the course of normal clinical practice, the investigators will be able to discern if fascial pathology contributes to chronic low back pain and if this treatment approach may provide clinical benefit to patients in the form of pain reduction and/or reduction in pain medication use.
Read the detailed description
This is a prospective, observational clinical study that will be run through a private practice clinic.
New patients to the clinic that complain of chronic lower back pain will be evaluated for inclusion and exclusion criteria and appropriately recruited and enrolled into the study. The baseline evaluation will take approximately 1.5hours to complete, and will include the following: a standardized pain scale questionnaire; a baseline questionnaire that assesses duration of current pain and previous interventions; physical examination with novel techniques to assess strength; and musculoskeletal ultrasound in the lower back.
Specific physical examination techniques will assess strength of the subject on both prone straight leg raise as well as hip external rotation. Then, the investigators will test how adding myofascial tension along the lower back may affect these results. Musculoskeletal ultrasound will examine specifically the aponeurosis of the erector spinae and the posterior layer of the thoracolumbar fascia at T11, T12, and L1. These areas will be graded on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue.
Participants who have myofascial damage identified on ultrasound and are scheduled for injection treatment as part of normal clinical care will have a diagnostic injection of prolotherapy (0.3% lidocaine + 15% dextrose) in those areas as the first step of the procedure. Pre and post injection muscle testing will be performed. The treatment session then will be completed per normal clinical care; this may include injection at other locations and injection of autologous platelet-rich plasma. Routine follow-up will be scheduled at 3 months.
At 3 months, the follow-up visit will include the following: the same pain scale questionnaire; a follow-up questionnaire to assess changes in function and pain medication; physical examination as before; musculoskeletal ultrasound in the specified areas.
New patients to the clinic who do not have chronic low back pain >12 weeks will be asked to participate as controls, and will undergo a similar questionnaire, and the same physical examination and musculoskeletal ultrasound.
- Conditions
- Musculoskeletal Pain, Low Back Pain, Myofascial Pain
- Being tested
- Prolotherapy
- Keywords
- Chronic Low Back Pain, Myofascial pain, Tensegrity, Prolotherapy, Platelet-Rich Plasma
- Medical subject headings
- Musculoskeletal Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyProcedure or surgery
Also called injection therapy
Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Participants >18 years old who meet inclusion and exclusion criteria, and have findings on physical exam and ultrasound that suggest potential benefit from prolotherapy. Receives: Procedure: Prolotherapy | |
| Controls | Participants >or =18 years old who do not complain of lower back pain, but consent to have physical examination testing and musculoskeletal ultrasound of the lower back to evaluate these areas. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale
Improved lower back pain / functionality.
Pain will be discerned on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain the participant has experienced. There will be no subscales provided, and only whole numbers will be allowed to be reported.
Measured: At baseline and at 3 month follow-up.
MSK Ultrasound
Musculoskeletal ultrasound will evaluate specific areas in the lower back on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue. The scale is described as follows:
0= No significant compressibility (well defined)
- Mild compressibility but no translation (heterogeneous)
- Moderate compressibility, mild translation (heterogeneous, poorly organized)
- Significant compressibility and translation (heterogeneous, poorly organized)
The results from each of the areas evaluated will then be summed for a total composite score. All values, including the individual area score and total composite score, will be recorded. Higher scores are considered worse outcomes. The results of the ultrasound evaluation will be determined solely by the principal investigator.
Measured: At baseline and at 3 month follow-up
Secondary outcomes (1)
Medications
Reduced use (dose or frequency) of pain medications
Measured: At baseline and at 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start6 Jun 2019
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProloAustin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley D. Fullerton, MD, ProloAustin
- Investigators
- Bradley Fullerton, MD, Principal investigator, ProloAustin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940313
- Sponsor's protocol ID
- ICMS-2019-004
- Status last verified
- Nov 2023
- First submitted
- 4 May 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dischiavi SL, Wright AA, Hegedus EJ, Bleakley CM. Biotensegrity and myofascial chains: A global approach to an integrated kinetic chain. Med Hypotheses. 2018 Jan;110:90-96. doi: 10.1016/j.mehy.2017.11.008. Epub 2017 Nov 20.
PubMed 29317079Swanson RL 2nd. Biotensegrity: a unifying theory of biological architecture with applications to osteopathic practice, education, and research--a review and analysis. J Am Osteopath Assoc. 2013 Jan;113(1):34-52. doi: 10.7556/jaoa.2013.113.1.34.
PubMed 23329804Fullerton BD, Reeves KD. Ultrasonography in regenerative injection (prolotherapy) using dextrose, platelet-rich plasma, and other injectants. Phys Med Rehabil Clin N Am. 2010 Aug;21(3):585-605. doi: 10.1016/j.pmr.2010.06.003.
PubMed 20797551Todorov PT, Nestorova R, Batalov A. Diagnostic value of musculoskeletal ultrasound in patients with low back pain - a review of the literature. Med Ultrason. 2018 Feb 4;1(1):80-87. doi: 10.11152/mu-1245.
PubMed 29400373
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03940313
- Acronym / sponsor ID
- ICMS-2019-004
- Conditions
- Musculoskeletal Pain, Low Back Pain, Myofascial Pain
- Keywords
- Chronic Low Back Pain, Myofascial pain, Tensegrity, Prolotherapy, Platelet-Rich Plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ProloAustinUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 7 May 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.
This is a prospective study on chronic low back pain patients aimed at investigating how findings on a physical examination and musculoskeletal ultrasound may correlate with myofascial damage in the lower back. By comparing these findings with a control group and collecting follow up data on patients treated in the course of normal clinical practice, the investigators will be able to discern if fascial pathology contributes to chronic low back pain and if this treatment approach may provide clinical benefit to patients in the form of pain reduction and/or reduction in pain medication use.
Detailed description
This is a prospective, observational clinical study that will be run through a private practice clinic.
New patients to the clinic that complain of chronic lower back pain will be evaluated for inclusion and exclusion criteria and appropriately recruited and enrolled into the study. The baseline evaluation will take approximately 1.5hours to complete, and will include the following: a standardized pain scale questionnaire; a baseline questionnaire that assesses duration of current pain and previous interventions; physical examination with novel techniques to assess strength; and musculoskeletal ultrasound in the lower back.
Specific physical examination techniques will assess strength of the subject on both prone straight leg raise as well as hip external rotation. Then, the investigators will test how adding myofascial tension along the lower back may affect these results. Musculoskeletal ultrasound will examine specifically the aponeurosis of the erector spinae and the posterior layer of the thoracolumbar fascia at T11, T12, and L1. These areas will be graded on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue.
Participants who have myofascial damage identified on ultrasound and are scheduled for injection treatment as part of normal clinical care will have a diagnostic injection of prolotherapy (0.3% lidocaine + 15% dextrose) in those areas as the first step of the procedure. Pre and post injection muscle testing will be performed. The treatment session then will be completed per normal clinical care; this may include injection at other locations and injection of autologous platelet-rich plasma. Routine follow-up will be scheduled at 3 months.
At 3 months, the follow-up visit will include the following: the same pain scale questionnaire; a follow-up questionnaire to assess changes in function and pain medication; physical examination as before; musculoskeletal ultrasound in the specified areas.
New patients to the clinic who do not have chronic low back pain >12 weeks will be asked to participate as controls, and will undergo a similar questionnaire, and the same physical examination and musculoskeletal ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Procedure: ProlotherapyParticipants >18 years old who meet inclusion and exclusion criteria, and have findings on physical exam and ultrasound that suggest potential benefit from prolotherapy. |
| Controls | – | –Participants >or =18 years old who do not complain of lower back pain, but consent to have physical examination testing and musculoskeletal ultrasound of the lower back to evaluate these areas. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic lower back pain that meet inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Age > or = 18 years old
- Chronic lower back pain > or = 12 weeks duration
Key exclusion criteria (4 listed)
- History of stroke preventing bilateral muscle strength testing
- History of scoliosis that may affect myofascial dynamics
- Acute radiculopathy/sciatica or pain that limits movement for physical examination
- Unable to lie prone for physical examination
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 |
|---|---|---|
| ProlotherapyAlso: injection therapyMusculoskeletal injection of lidocaine + 15% dextrose into damaged tissue | Procedure or surgery | Subjects |
Primary outcome
Pain Scale
Time frame: At baseline and at 3 month follow-up.
Improved lower back pain / functionality. Pain will be discerned on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain the participant has experienced. There will be no subscales provided, and only whole numbers will be allowed to be reported.
MSK Ultrasound
Time frame: At baseline and at 3 month follow-up
Musculoskeletal ultrasound will evaluate specific areas in the lower back on a 4-point scale (0 to 3), evaluating compressibility and heterogeneity of the tissue. The scale is described as follows: 0= No significant compressibility (well defined) 1. Mild compressibility but no translation (heterogeneous) 2. Moderate compressibility, mild translation (heterogeneous, poorly organized) 3. Significant compressibility and translation (heterogeneous, poorly organized) The results from each of the areas evaluated will then be summed for a total composite score. All values, including the individual area score and total composite score, will be recorded. Higher scores are considered worse outcomes. The results of the ultrasound evaluation will be determined solely by the principal investigator.
1 secondary outcome
Medications
Time frame: At baseline and at 3 month follow-up
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 18 Nov 2023.
- Background: PubMed 29317079Dischiavi SL, Wright AA, Hegedus EJ, Bleakley CM. Biotensegrity and myofascial chains: A global approach to an integrated kinetic chain. Med Hypotheses. 2018 Jan;110:90-96. doi: 10.1016/j.mehy.2017.11.008. Epub 2017 Nov 20.
- Background: PubMed 23329804Swanson RL 2nd. Biotensegrity: a unifying theory of biological architecture with applications to osteopathic practice, education, and research--a review and analysis. J Am Osteopath Assoc. 2013 Jan;113(1):34-52. doi: 10.7556/jaoa.2013.113.1.34.
- Background: PubMed 20797551Fullerton BD, Reeves KD. Ultrasonography in regenerative injection (prolotherapy) using dextrose, platelet-rich plasma, and other injectants. Phys Med Rehabil Clin N Am. 2010 Aug;21(3):585-605. doi: 10.1016/j.pmr.2010.06.003.
- Background: PubMed 29400373Todorov PT, Nestorova R, Batalov A. Diagnostic value of musculoskeletal ultrasound in patients with low back pain - a review of the literature. Med Ultrason. 2018 Feb 4;1(1):80-87. doi: 10.11152/mu-1245.
- Clinical facility for studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Bradley Fullerton, MD principal investigator
ProloAustin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain and Low Back Pain, run by ProloAustin 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 4 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 18 Nov 2023. 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?
Pain Scale (time frame: At baseline and at 3 month follow-up.). 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?
On the ClinicalTrials.gov record for NCT03940313, which also lists 4 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 18 Nov 2023.