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Behavioural Intervention

Enhanced Educational Control Group (CG-2) for Chronic Lower Back Pain

N/A

Waitlist Available

Led By Nada Lukkahatai, PhD, MSN, RN

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month post completion of the treatment

Awards & highlights

Study Summary

This trial will test auricular point acupressure (APA), a non-invasive, easily administered, patient-controlled, and non-pharmacological strategy, to provide rapid, safe, and an innovative solution for chronic low back pain (cLBP) in older adults.

Eligible Conditions

Chronic Lower Back Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month post completion of the treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month post completion of the treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post completion of the treatment 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 intensity as assessed by the Numeric Rating Scale (NRS)

Pain interference as assessed by the Brief Pain Inventory-short form pain interference subscale

Physical Function as assessed by the Roland Morris Disability Questionnaire (RMDQ)

Secondary outcome measures

Fear-Avoidance as assessed by the Fear-avoidance beliefs questionnaire (FABQ)

Memory as assessed by the Stroop Test

Number of participants who use opioids

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Educational Control Group (CG-2)Experimental Treatment1 Intervention

Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups.

Group II: T-APAActive Control1 Intervention

Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain.

Group III: NT-APAActive Control1 Intervention

The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group.

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Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,672 Previous Clinical Trials

28,018,391 Total Patients Enrolled

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,725 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,262 Previous Clinical Trials

14,822,892 Total Patients Enrolled

Frequently Asked Questions

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

Is recruitment still available for this trial?

"Information available on clinicaltrials.gov indicates that this trial is no longer taking applicants, as the study was initially announced on March 1st 2019 and edited most recently November 16th 2022. However, 333 other medical studies are actively recruiting at the moment."

Answered by AI

What aim is the research team attempting to attain with this clinical trial?

"The principal objective of this investigation, which will follow-up on participants for approximately one month post treatment completion, is to assess Pain Interference through the Roland Morris Disability Questionnaire (RMDQ). Secondary objectives encompass Fear-Avoidance as measured by the Fear-avoidance beliefs questionnaire (FABQ), Quality of Life via Patient-Reported Outcomes Measurement Information System (PROMIS-29) and Pain using the Pain and Catastrophizing Scale (PCS); each tool uses a different Likert scale ranging from zero to four or six."

Answered by AI