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NCT Number: NCT05657964

Randomized Trial for cLBP (Gokhale Project)

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).

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Outpatient Surgery Center/Stanford Spine Clinic

Redwood City, California, 94063, United States

Location status: Recruiting

Location contact

Susmita Chatterjee, MS/CCRP

CONTACT

[email protected]

6504979271

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gokhale sensor

Device

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.

Other names: Only for Gokhale ARM

Primary outcomes

  1. NPRs ( national pain score)

    Time frame: 6-12 weeks

    Average pain score related to lower back

  2. PROMIS-29 questionnaire

    Time frame: 6-12 weeks

    Patient-Reported Outcomes Measurement Information System

  3. RMDQ questionnaire

    Time frame: 6-12 weeks

    Roland Morris Disability Questionnaire

Secondary outcomes

  1. patient satisfaction and adherence

    Time frame: 12 months

    Post study evaluation of patient's satisfaction.

  2. Type, incidence and severity of complications and adverse events

    Time frame: 12 months

  3. Concurrent pain medication use (including opioids)

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ruopeng Sun, PHD

CONTACT

[email protected]

6507217600

Susmita Chatterjee, MS

CONTACT

[email protected]

6504979271

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Randomized Comparative Effectiveness Trial of Two Postural Therapies for People With Chronic Lower Back Pain (cLBP)-Gokhale Project

Acronym: Gokhale

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Dec 20, 2022
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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