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TENS for Lower Back Pain

N/A
Waitlist Available
Research Sponsored by Hinge Health, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 4
Awards & highlights
No Placebo-Only Group

Summary

This trial compares a portable device (HFIT) to a standard device (TENS) to treat muscle pain. Results show HFIT is more effective.

Eligible Conditions
  • Lower Back Pain
  • Chronic Knee Pain
  • Chronic Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain MCID
Secondary study objectives
Anxiety
Depression
Function MCID (Back)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TENSExperimental Treatment1 Intervention
Participants received a TENS device to treat their chronic pain and took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists. Participants were encouraged to use the TENS device for at least 1 hour daily for 4 weeks.
Group II: HFITExperimental Treatment1 Intervention
Participants received a HFIT device to treat their chronic pain and took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists. Participants were encouraged to use the HFIT device for at least 1 hour daily for 4 weeks.
Group III: ControlActive Control1 Intervention
Participants took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TENS
2011
Completed Phase 2
~2040

Find a Location

Who is running the clinical trial?

Hinge Health, IncLead Sponsor
~130 spots leftby Nov 2025
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