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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I haven't been hospitalized for 3 or more days in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks (end of active treatment) and 10 weeks (sustainability)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in PROMIS 6b pain interference scale
Secondary outcome measures
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
1,610 Previous Clinical Trials
3,304,884 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Veterans who are part of the VA Ann Arbor Healthcare System.I have had acupuncture or acupressure in the last 3 months.My medical records confirm I have non-specific low back pain.I had back surgery within the last 2 years.I can understand and follow the study's requirements.I have had pain at a level of 4 out of 10 for at least 3 months.I haven't been hospitalized for 3 or more days in the last month.I don't have any back surgery or injections planned for the next 10 weeks.You haven't changed your pain medication for the past 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: wait list control
- Group 2: acupressure intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment opportunities currently available for this clinical investigation?
"According to the clinicaltrials.gov page, this research endeavour is in active recruitment of participants. Initially posted on October 3rd 2022 and amended lastly on October 5th 2022, it is currently open for applications."
Answered by AI
What is the cap on participants in this clinical investigation?
"Indeed, the information available on clinicaltrials.gov attests that this investigation is still actively seeking participants. Originally published on October 3rd 2022 and revised just two days later, 300 subjects are required to join from a single hospital site."
Answered by AI
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