Randomized Trial for cLBP (Gokhale Project)

Lower Back Pain Chronic Clinical Trial

— Gokhale  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05657964
• Other study ID #: 60640
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Ruopeng Sun, PHD
• Phone: 6507217600
• Email: rusun[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain Chronic

Intervention

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 sent to a HIPAA compliance server and shared with Stanford researchers.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NPRs ( national pain score)	Average pain score related to lower back	6-12 weeks
Primary	PROMIS-29 questionnaire	Patient-Reported Outcomes Measurement Information System	6-12 weeks
Primary	RMDQ questionnaire	Roland Morris Disability Questionnaire	6-12 weeks
Secondary	patient satisfaction and adherence	Post study evaluation of patient's satisfaction.	12 months
Secondary	Type, incidence and severity of complications and adverse events		12 months
Secondary	Concurrent pain medication use (including opioids)		12 months