Randomized Trial for cLBP (Gokhale Project)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gokhale sensor.
- Who it may be relevant to
- Registry conditions: Lower Back Pain Chronic. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Comparative Effectiveness Trial of Two Postural Therapies for People With Chronic Lower Back Pain (cLBP)-Gokhale Project
Overview
The study aims to compare the effectiveness of the Gokhale Method posture therapy for low back pain (LBP) management to standard physical therapy (PT) with posture training. The second aim of this study is to evaluate usability and user adherence of the online/digital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App). The investigator hopes to learn: The effectiveness of the Gokhale Method posture therapy for low back pain management, in comparison to the effectiveness of standard physical therapy with posture training. the usability and user adherence of the online/digital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App).
Detailed description
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.
Interventions
- Device Gokhale sensor
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 se
Primary outcome measures
- NPRs ( national pain score) [Time frame: 6-12 weeks]
- PROMIS-29 questionnaire [Time frame: 6-12 weeks]
- RMDQ questionnaire [Time frame: 6-12 weeks]
Secondary outcome measures (3)
- patient satisfaction and adherence [Time frame: 12 months]
- Type, incidence and severity of complications and adverse events [Time frame: 12 months]
- Concurrent pain medication use (including opioids) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 18-65 years old (working age population).
- NPRS score 4 or more for lower back.
- RMDQ score 7 and above.
- English speaking population
- Need insurance
Exclusion criteria
- Pregnancy (as stated by patient)
- With cognitive or communication impairment .
- Patients recommended for surgery
- Participating in other form of intervention.
- Prior history of chronic neurological disorder that impacts mobility (e.g. stroke, Parkinson's disease, multiple sclerosis)
- Fibromyalgia
- Underwent PT treatment for low back pain in the last 6 months
- Underlying mental disorder/untreated depression or presence of neurologic disorders such as MS, Alzheimers, Parkinsons
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Outpatient Surgery Center/Stanford Spine Clinic — Redwood City
Identifiers
NCT: NCT05657964 · 60640