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Standard Acupuncture for Chronic Lower Back Pain (BackInAction Trial)
N/A
Waitlist Available
Led By Karen J Sherman, PhD, MPH
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has back pain that is uncomplicated with or without radicular pain
Is at least 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient health care utilization costs from baseline to 12 months net of their utilization from the previous 12 months. eq-5d-5l: patient self-report at baseline, 3-, 6- and 12-months
Awards & highlights
BackInAction Trial Summary
This trial is testing whether acupuncture can help improve back-related disability and pain in older adults with chronic low back pain.
Who is the study for?
This trial is for older adults aged 65+ with chronic low back pain who have seen a healthcare provider for it in the past year. They must be able to consent and not live in nursing homes, be on hospice care, or have certain types of back pain like cancer-related ones. No recent acupuncture, major surgeries, compensation cases related to back pain, or severe cognitive impairments are allowed.Check my eligibility
What is being tested?
The study compares standard acupuncture (15 sessions over 3 months) with enhanced acupuncture (an additional 6 sessions over the next three months) against usual care alone. It aims to see if these treatments reduce disability and improve pain scores in older adults with chronic lower back pain.See study design
What are the potential side effects?
Acupuncture may cause minor side effects such as soreness at needle sites, minor bleeding or bruising after treatment. Rarely more serious issues can occur like infections or injury from needles.
BackInAction Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have back pain, with or without leg pain.
Select...
I am 65 years old or older.
Select...
I have had back pain for at least 3 months.
BackInAction Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patient health care utilization costs from baseline to 12 months net of their utilization from the previous 12 months. eq-5d-5l: patient self-report at baseline, 3-, 6- and 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient health care utilization costs from baseline to 12 months net of their utilization from the previous 12 months. eq-5d-5l: patient self-report at baseline, 3-, 6- and 12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in back-related disability at 6-month post randomization (continuous)
Secondary outcome measures
Achieving MCID in Pain, Pain Interference with Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (binary)
Achieving Minimal Clinically Important Difference (MCID) in back-related dysfunction at 3-, 6-, and 12-months (binary)
Change in Pain, Pain Interference with Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (continuous)
+4 moreOther outcome measures
Change in ability to engage in social roles at 3-, 6- and 12-month (continuous)
Change in fatigue at 3-, 6- and 12-month (continuous)
Change in sleep duration at 3-, 6- and 12-month and in sleep during at 6-months (continuous)
+3 moreBackInAction Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Standard AcupunctureExperimental Treatment1 Intervention
Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months.
Group II: Enhanced AcupunctureExperimental Treatment1 Intervention
Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months.
Group III: Usual CareActive Control1 Intervention
Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Find a Location
Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,113,021 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,126 Total Patients Enrolled
Karen J Sherman, PhD, MPHPrincipal InvestigatorKaiser Permanente
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for cancer.I have had a fever most days in the last month or lost more than 10 lbs without trying.I have back pain, with or without leg pain.I am 65 years old or older.I have had back pain for at least 3 months.I have not had acupuncture in the last 6 months.I am not living in a nursing home, on Hospice, or receiving palliative care.My back pain is due to cancer, fractures, infection, or inflammation.I have had low back surgery in the last 3 months.I can make my own medical decisions.I have seen a doctor for low back pain in the last year.I am deaf and do not use spoken language.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Acupuncture
- Group 2: Enhanced Acupuncture
- Group 3: Usual Care
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.
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT04982315 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are currently involved with this investigative experiment?
"Affirmative. Clinicaltrials.gov displays that this research, which was initially published on the 12th of August 2021, is currently enrolling participants. 789 volunteers are required to be sourced from 4 different medical centres."
Answered by AI
How many centers are managing this investigation?
"This trial is now being conducted in four distinct sites, such as Oakland, New york and Walnut Creek. It would be prudent to choose the nearest site of these locations to avoid unnecessary travel."
Answered by AI
What is the current status of enrollment for this trial?
"Clinicaltrials.gov verifies that this medical trial is actively seeking participants, with the first posting on August 12th 2021 and most recent update occurring October 17th 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
California
What site did they apply to?
Kaiser Permanente Division of Research
Institute for Family Health
Sutter Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
0
3+
Why did patients apply to this trial?
Medications, steroidal injections and RF ablation haven't been effective in reducing back pain.
PatientReceived no prior treatments
I'd like to receive information and and help concerning my back pain.id also like to contribute to medicine,as well as financial compensation.
PatientReceived 2+ prior treatments
I have tried several medications including naproxen sodium, gabapentin, mexloxicam and others to no effect. I have been treated with chiropractic, PT, subdural steroid injections, stem cells and RF ablation, which have given only modest and temporary relief.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
If financial compensation is available? Is this a double blind study? If so, is there a placebo treatment?
PatientReceived 2+ prior treatments
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