100 participants with chronic low back pain will be recruited through the Stanford PMR
clinics (Redwood City, Emeryville, Los Gatos, and Palo Alto). Information about the study
will also be disseminated to the Stanford Primary Care clinics and through community
advertisements.
Patients will be referred to the reaserch team by the providers who is been recommended
for Physical Therapy.
Research team personnel will approach the recommended patients via email and will screen
them prior to consenting for eligibility criteria by sending out a set of questionnaires
via Redcap.
Eligible patients will be consented remotely via Redcap and will be subjected to
randomization.
Eligible and consented participants will be randomly assigned (1:1) into one of the two
intervention groups. Prior to intervention, participants will be asked to complete
questionnaires on demographics, self-reported levels of pain, functional status, and
disability levels. The questionnaires include:
Roland Morris Disability Questionnaire (RMDQ), Numeric Pain Rating Scale (NPRS),
Patient-Reported Outcomes Measurement Information System (PROMIS-29),
Participants will be randomized (1:1) into the Gokhale method posture treatment (Gokhale)
arm will receive a 18-sessions coaching under the Gokhale Elements course (may spread
between 6-12 weeks, 1- 2 times per week, online delivery). Participants randomized into
the standard care/physical therapy (PT) arm will similarly receive a standardized PT
prescription during a 6-12 weeks period, meeting 1-2 times per week, to include posture
education and training, therapeutic exercise instructions and development of an
independent home exercise program.
Participants enrolled in the Gokhale Arm will be provided the Gokhale PostureTracker, a
wearable posture monitoring sensor developed for interactive posture coaching, and a
loaner smartphone with pre-installed App. Participants will be provided instruction to
apply the sensor on their lumbar area and receive real-time visual feedback on their
posture kinematic during the class. Participants can also perform normal daily activities
while wearing the device. Data collected by the sensor will be sent to a HIPAA compliance
server and shared with Stanford researchers.
Participant will complete remote follow-up assessments upon completion of their
respective intervention, and at 6, and 12-month post intervention.
Primary outcomes assessed at baseline and each follow-up include the RMDQ,NPRS,
PROMIS-29, PCS Secondary outcomes at each timepoint include 1) patient satisfaction and
adherence. 2) Type, incidence and severity of complications and adverse events. 3)
Concurrent pain medication use (including opioids) All collected data will be stored in a
Stanford-secured server. No data would be transmitted to a third party. Access to the
data will be limited exclusively to members of the research team.