Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT03940313|
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment|
|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|
|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|
Participants >18 years old who meet inclusion and exclusion criteria, and have findings on physical exam and ultrasound that suggest potential benefit from prolotherapy.
Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
Other Name: injection therapy
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.
- 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)
- 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.
- Medications [ Time Frame: At baseline and at 3 month follow-up ]Reduced use (dose or frequency) of pain medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940313
|Contact: Bradley Fullerton, MDfirstname.lastname@example.org|
|United States, Texas|
|Austin, Texas, United States, 78746|
|Contact: Bradley Fullerton, MD 512-347-7246 email@example.com|
|Principal Investigator:||Bradley Fullerton, MD||ProloAustin|