Recruiting

cLBPRandomized Trial for cLBP (Gokhale Project)

Sponsor:

Stanford University

Code:

NCT05657964

Conditions

Lower Back Pain Chronic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Gokhale sensor

Study Details

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

Study ID

NCT05657964

Start date

Jul 1, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

Primary outcome measure

NPRs ( national pain score) [ Time Frame: 6-12 weeks ]
PROMIS-29 questionnaire [ Time Frame: 6-12 weeks ]
RMDQ questionnaire [ Time Frame: 6-12 weeks ]

Central Contacts and Locations

Central contacts

Ruopeng Sun, PHD

6507217600 rusun@stanford.edu

Susmita Chatterjee, MS

6504979271 susmitac@stanford.edu

Locations

Outpatient Surgery Center/Stanford Spine Clinic

Recruiting

Redwood City, California, United States, 94063

Contacts

Susmita Chatterjee, MS/CCRP

6504979271 susmitac@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-01-09.