Health TrialsbyHealthPanel

Randomized Trial for cLBP (Gokhale Project)

ConditionLower Back Pain Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorStanford University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-65 years old (working age population).

NPRS score 4 or more for lower back.

RMDQ score 7 and above.

English speaking population

Disqualifiers

Pregnancy (as stated by patient)

With cognitive or communication impairment .

Patients recommended for surgery

Participating in other form of intervention.

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Gokhale ARM1 intervention
Group B: Physical Therapy ARM0 interventions

Trial outcomes

Primary outcomes

1

NPRs ( national pain score)

Average pain score related to lower back

Time frame
6-12 weeks
2

PROMIS-29 questionnaire

Patient-Reported Outcomes Measurement Information System

Time frame
6-12 weeks
3

RMDQ questionnaire

Roland Morris Disability Questionnaire

Time frame
6-12 weeks

Secondary outcomes

1

patient satisfaction and adherence

Post study evaluation of patient's satisfaction.

Time frame
12 months
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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