Condition or disease | Intervention/treatment |
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Musculoskeletal Pain Low Back Pain Myofascial Pain | Procedure: Prolotherapy |
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 Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain |
Estimated Study Start Date : | June 11, 2019 |
Estimated Primary Completion Date : | August 1, 2020 |
Estimated Study Completion Date : | March 22, 2021 |
Group/Cohort | Intervention/treatment |
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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.
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Procedure: Prolotherapy
Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
Other Name: injection therapy
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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.
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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.
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)
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.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bradley Fullerton, MD | 512-347-7246 | info@proloaustin.com |
United States, Texas | |
ProloAustin | Recruiting |
Austin, Texas, United States, 78746 | |
Contact: Bradley Fullerton, MD 512-347-7246 info@proloaustin.com |
Principal Investigator: | Bradley Fullerton, MD | ProloAustin |
Tracking Information | |||||
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First Submitted Date | May 4, 2019 | ||||
First Posted Date | May 7, 2019 | ||||
Last Update Posted Date | May 23, 2019 | ||||
Estimated Study Start Date | June 11, 2019 | ||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
Medications [ Time Frame: At baseline and at 3 month follow-up ] Reduced use (dose or frequency) of pain medications
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Original Secondary Outcome Measures |
Medications [ Time Frame: At 3 month follow-up ] Reduced use of pain medications
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain | ||||
Official Title | Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain | ||||
Brief 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. 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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Adults with chronic lower back pain that meet inclusion and exclusion criteria. | ||||
Condition |
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Intervention | Procedure: Prolotherapy
Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
Other Name: injection therapy
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 22, 2021 | ||||
Estimated Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03940313 | ||||
Other Study ID Numbers | ICMS-2019-004 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Bradley D. Fullerton, MD, ProloAustin | ||||
Study Sponsor | ProloAustin | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | ProloAustin | ||||
Verification Date | May 2019 |