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Randomized Trial for cLBP (Gokhale Project) (Gokhale)

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ClinicalTrials.gov Identifier: NCT05657964
Recruitment Status : Not yet recruiting
First Posted : December 20, 2022
Last Update Posted : April 11, 2023
Sponsor:
Information provided by (Responsible Party):
Matthew W Smuck, Stanford University

Study Description
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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).


Condition or disease Intervention/treatment
Lower Back Pain Chronic Device: Gokhale sensor

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Randomized Comparative Effectiveness Trial of Two Postural Therapies for People With Chronic Lower Back Pain (cLBP)-Gokhale Project
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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 Name: Only for Gokhale 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients coming in PM&R clinic with chronic lower back pain
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05657964


Contacts
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Contact: Ruopeng Sun, PHD 6507217600 rusun@stanford.edu
Contact: Susmita Chatterjee, MA 6504979271 susmitac@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Matthew Smuck, MD Stanford PM&R Orthopedic surgery
More Information
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Responsible Party: Matthew W Smuck, Assoc Professor, Stanford University
ClinicalTrials.gov Identifier: NCT05657964    
Other Study ID Numbers: 60640
First Posted: December 20, 2022    Key Record Dates
Last Update Posted: April 11, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Full data access will be limited to members of the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations