Randomized Trial for cLBP (Gokhale Project)

NCT05657964 | Recruiting

• 1 other identifier: 60640
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lower Back Pain Chronic

Outcome Measures

Primary Outcomes (3)

• NPRs ( national pain score)

  Average pain score related to lower back

  6-12 weeks

• PROMIS-29 questionnaire

  Patient-Reported Outcomes Measurement Information System

  6-12 weeks

• RMDQ questionnaire

  Roland Morris Disability Questionnaire

  6-12 weeks

Secondary Outcomes (3)

• patient satisfaction and adherence

  12 months

• Type, incidence and severity of complications and adverse events

  12 months

• Concurrent pain medication use (including opioids)

  12 months

Study Arms (2)

Gokhale ARM

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.

Device: Gokhale sensor

Physical Therapy ARM

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.

Interventions

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.

Also known as: Only for Gokhale ARM

Gokhale ARM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients coming in PM\&R clinic with chronic lower back pain

You may qualify if:

• years old (working age population).
• NPRS score 4 or more for lower back.
• RMDQ score 7 and above.
• English speaking population
• Need insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Outpatient Surgery Center/Stanford Spine Clinic

Redwood City, California, 94063, United States

RECRUITING

Study Officials

• Matthew Smuck, MD

  Stanford PM&R Orthopedic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruopeng Sun, PHD

CONTACT

6507217600; rusun@stanford.edu

Susmita Chatterjee, MS

CONTACT

6504979271; susmitac@stanford.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 20, 2022
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)