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Self-Administered Acupressure for Chronic Back Pain

N/A
Recruiting
Led By Sarah L. Krein, PhD RN
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-specific low back pain confirmed through electronic medical records (i.e., ICD-10 codes: M54.5, M54.40, 41, 42, M54.89)
Reported pain severity of 4/10 that has persisted for at least 3 months and present on most days
Must not have
Received acupuncture or acupressure in past 3 months
Had back surgery in the past 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
Awards & highlights

Summary

This trial will test the effectiveness of self-administered acupressure to treat chronic low back pain in Veterans.

Who is the study for?
This trial is for Veterans with chronic low back pain who are enrolled at VA Ann Arbor Healthcare System. They must have had a pain severity of at least 4/10 for over three months and be medically stable, without hospital stays or changes in pain meds recently. Pregnant individuals, those with recent back surgery or acupressure treatments, or cognitive impairments that affect consent ability cannot participate.
What is being tested?
The study tests if self-administered acupressure can help manage chronic low back pain in Veterans. Participants will learn about acupressure and use an app to guide their daily sessions over six weeks. The effectiveness will be measured through surveys assessing pain's impact on function, fatigue, and sleep quality.
What are the potential side effects?
Acupressure is generally considered safe but may cause temporary soreness or bruising at the pressure points. Some individuals might experience relaxation-related side effects such as light-headedness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My medical records confirm I have non-specific low back pain.
Select...
I have had pain at a level of 4 out of 10 for at least 3 months.
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I haven't been hospitalized for 3 or more days in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had acupuncture or acupressure in the last 3 months.
Select...
I had back surgery within the last 2 years.
Select...
I can understand and follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in PROMIS 6b pain interference scale
Secondary study objectives
change in PROMIS 8a fatigue scale
change in PROMIS 8b sleep disturbance scale
change in Roland Morris Disability scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: acupressure interventionExperimental Treatment1 Intervention
Receives access to the acupressure intervention
Group II: wait list controlActive Control1 Intervention
No access to the acupressure intervention during the study period

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,770 Total Patients Enrolled
Sarah L. Krein, PhD RNPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
2 Previous Clinical Trials
489 Total Patients Enrolled

Media Library

Self-Administered Acupressure Clinical Trial Eligibility Overview. Trial Name: NCT05423145 — N/A
Lower Back Pain Research Study Groups: wait list control, acupressure intervention
Lower Back Pain Clinical Trial 2023: Self-Administered Acupressure Highlights & Side Effects. Trial Name: NCT05423145 — N/A
Self-Administered Acupressure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423145 — N/A
~105 spots leftby Nov 2025
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