Biotensegrity: Thoracolumbar Fascial Integrity in Chronic Low Back Pain
Condition: Musculoskeletal Pain; Low Back Pain; Myofascial Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain
Study type: Observational

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.
    

Intervention name(s): Prolotherapy
Intervention type(s): Procedure
Intervention description(s): Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
Other intervention name(s): injection therapy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with chronic lower back pain that meet inclusion and exclusion criteria.
      
Keywords: Chronic Low Back Pain; Myofascial pain; Tensegrity; Prolotherapy; Platelet-Rich Plasma