Randomized Trial for cLBP (Gokhale Project)

Conditions

• Lower Back Pain Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

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.

Study Details

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).

Key Dates

Start date

Jul 1, 2024

Status verified

Jan 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2030

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

NPRs ( national pain score) [ Time Frame: 6-12 weeks ]

Central Contacts

• Ruopeng Sun, PHD
  6507217600
  [email protected]
• Susmita Chatterjee, MS
  6504979271
  [email protected]

Locations (1)

Find similar trials in Redwood City, CA