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Electroacupuncture Frequency-related Effects on Non-specific Low Back Pain in Older Adults.

NCT03802045 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2019-03-29

No results posted yet for this study

Summary

Background: Low back pain (LBP) is the most frequent complaint in the clinical practice. Electroacupuncture treatment may be effective, however, the evidence supporting this possibility is still limited, especially in older adults.

Methods: A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific low back pain will be randomly assigned into one of five groups: three electroacupuncture groups (low, high and alternating frequency), a control and a placebo group. The electroacupuncture will be applied twice a week (30 minutes per session) for 5 weeks. The primary clinical outcome will be pain intensity. The secondary outcomes include: quality of pain, physical functioning, perceived overall effect, emotional functionality, patient satisfaction and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed-up after 6 and 12 months to check the effects in the medium and long term.

Discussion: Results of this trial will help clarify the therapeutic effect of different frequencies of electroacupuncture for chronic low back pain in older adults and to determine the most effective electroacupuncture frequency.

Conditions

  • Low Back Pain

Interventions

PROCEDURE

Electroacupuncture

The interventions will be performed by acupuncture specialists with at least 3 years of clinical experience, who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments, including details such as acupuncture points and manipulation of electroacupuncture parameters. After the randomization, the acupuncturist will sequentially open the envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C) and placebo group (P), each containing 25 participants. The acupuncture points will be located and described according to the WHO Standard Acupuncture Locations. Based on the beneficial effects of previous clinical trials, the acupoints selected for this study will be: BL23, BL25, BL40, SP6 and KI3.

DEVICE

Needle

Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.

DEVICE

Adhesive Moxa

In the placebo group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-12-18
Completion
2021-12-17

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802045 on ClinicalTrials.gov