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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

Study 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 Pain
Chronic Knee Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 4

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain MCID

Secondary outcome measures

Anxiety

Depression

Function MCID (Back)

+2 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hinge Health, IncLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can participate in this clinical trial?

"This medical trial requires 288 patients suffering from chronic pain to meet the following criteria: between 18 and 64 years old, with a baseline pain intensity of 40/100 or above on the NPRS scale, and having lived with their condition for at least 3 months."

Answered by AI

Are there any openings for participants in this medical experiment at present?

"Per clinicaltrials.gov, this medical trial is not recruiting presently after its initial posting date of April 24th 2023 and the last update of April 18th 2023. However, there are 733 other trials actively seeking participants at the moment."

Answered by AI

Is the eligibility criteria for this investigation limited to those over eighteen years old?

"The eligibility requirements for this particular experiment stipulate that the age of participants should be between 18 and 64 years old. Additionally, there are 53 clinical trials available to minors and 623 more accessible to seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HFIT Versus TENS Study for Chronic Low Back and Knee Pain

2023. "HFIT Versus TENS Study for Chronic Low Back and Knee Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05821530.

All > Knee Pain