Thread-embedding Combined With Auricular Acupuncture for Non-specific Chronic Low Back Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2025-03-20

Brief Summary

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Low back pain (LBP) is a significant global health issue, with cases expected to rise by 36.4% by 2050. Chronic LBP (cLBP), lasting over three months, is mostly non-specific cLBP (cNLBP), posing a challenge for effective management. Common treatments include medication, exercise, and acupuncture.

This study explores the combined use of thread-embedding and auricular acupuncture for treating cNLBP, as combining these methods is thought to enhance effectiveness. Participants with cNLBP will be randomized into four groups to receive either the combination of both treatments, each treatment individually with a sham, or both shams. The study will last eight weeks, with four weeks of intervention and four weeks of follow-up. Treatment outcomes, including pain, disability, medication use, and quality of life, will be evaluated, along with monitoring for adverse effects.

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Detailed Description

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Low back pain (LBP) is a major public health issue worldwide. In 2020, there were over half a billion cases of LBP globally, and by 2050, the total number of LBP cases is expected to increase by 36.4% worldwide. LBP accounts for 7.7% of total Years Lived with Disability, making it the largest contributor to the global disability burden.

When lasting three months or more, LBP is classified as chronic (cLBP). Most cLBP is non-specific cLBP (cNLBP). Managing cNLBP remains challenging. Recommended therapies include short-term medication, manipulation, supervised exercise, cognitive behavioral therapy, and multidisciplinary treatment. According to the Clinical Practice Guideline from the American College of Physicians, clinicians and patients should initially consider non-pharmacologic treatments, including acupuncture as one of the options.

There is evidence regarding the effectiveness of thread-embedding acupuncture (TEA) and auricular acupuncture (AA) in the treatment of cNLBP. TEA uses the principle of selecting points on the body, while AA involves selecting points on the ear. The difference in the point selection principles of these two methods has led clinicians to often combine them in hopes of enhancing treatment efficacy. However, evidence on the effectiveness of combining these two methods in treating cNLBP remains lacking. This study aims to clarify whether the combination of these methods is more effective than using them individually.

Eligible participants with cNLBP, defined as LBP lasting more than three months without any reasonable explanation and determined by a physician to be nonspecific, will be enrolled and subsequently randomized into four groups: receiving the combination of TEA and AA (TEA + AA group), receiving TEA and sham AA (TEA + sham AA group), receiving AA and sham TEA (AA + sham TEA group), and receiving sham TEA and sham AA (Sham both group), with a 1:1:1:1 allocation ratio.

The study will last for eight weeks, with four weeks of intervention and four weeks of follow-up. AA and sham AA will be administered weekly during the four-week intervention (four sessions). TEA and sham TEA will be administered every two weeks during the four-week intervention (two sessions). Data on treatment efficacy will include disability index, pain score, amount of analgesic medication needed, quality of life score, and global improvement. Additionally, adverse effects will be monitored and recorded.

Conditions

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Chronic Non-Specific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TEA + AA

Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with auricular acupuncture (AA) every week in 4 weeks (4 sessions).

Group Type EXPERIMENTAL

Thread-embedding acupuncture

Intervention Type OTHER

Thread-embedding acupuncture is performed every week for 4 weeks, using a single Polydioxaone thread inserted into acupoints on the body through the needle. After the thread is inserted, the needle will be immediately withdrawn.

Auricular acupuncture

Intervention Type OTHER

Auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into therapeutic points on the ear. The patches with the needle will remain in place for one week.

TEA + sham AA

Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).

Group Type ACTIVE_COMPARATOR

Thread-embedding acupuncture

Intervention Type OTHER

Thread-embedding acupuncture is performed every week for 4 weeks, using a single Polydioxaone thread inserted into acupoints on the body through the needle. After the thread is inserted, the needle will be immediately withdrawn.

Sham auricular acupuncture

Intervention Type OTHER

Sham auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into non-therapeutic points on the ear. The patches with the needle will remain in place for one week.

AA + sham TEA

Auricular acupuncture (AA) every week in 4 weeks (4 sessions). Combined with sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions).

Group Type ACTIVE_COMPARATOR

Auricular acupuncture

Intervention Type OTHER

Auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into therapeutic points on the ear. The patches with the needle will remain in place for one week.

Sham thread-embedding acupuncture

Intervention Type OTHER

Sham thread-embedding acupuncture is performed every week for 4 weeks, using the needle without thread inserted into acupoints on the body. After insertion, the needle will be immediately withdrawn, and no thread will be left in the body.

Sham both

Sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).

Group Type SHAM_COMPARATOR

Sham thread-embedding acupuncture

Intervention Type OTHER

Sham thread-embedding acupuncture is performed every week for 4 weeks, using the needle without thread inserted into acupoints on the body. After insertion, the needle will be immediately withdrawn, and no thread will be left in the body.

Sham auricular acupuncture

Intervention Type OTHER

Sham auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into non-therapeutic points on the ear. The patches with the needle will remain in place for one week.

Interventions

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Thread-embedding acupuncture

Thread-embedding acupuncture is performed every week for 4 weeks, using a single Polydioxaone thread inserted into acupoints on the body through the needle. After the thread is inserted, the needle will be immediately withdrawn.

Intervention Type OTHER

Auricular acupuncture

Auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into therapeutic points on the ear. The patches with the needle will remain in place for one week.

Intervention Type OTHER

Sham thread-embedding acupuncture

Sham thread-embedding acupuncture is performed every week for 4 weeks, using the needle without thread inserted into acupoints on the body. After insertion, the needle will be immediately withdrawn, and no thread will be left in the body.

Intervention Type OTHER

Sham auricular acupuncture

Sham auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into non-therapeutic points on the ear. The patches with the needle will remain in place for one week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with low back pain at the outpatient clinic.
* Diagnosed with non-specific low back pain persisting for more than 3 months, without radiation to the legs.
* Pain-NRS score ≥ 4 on a 10-point scale.
* Independent ambulation capability (with or without walking aids).
* Consent to participate in the study.

Exclusion Criteria

* History of prior lumbar spine surgery.
* Known or suspected severe spinal conditions (e.g., cancer, vertebral fracture, spinal infection, or cauda equina syndrome).
* Signs of concurrent involvement of lumbar nerve roots, plexus, sciatic nerve, other leg nerves, or diagnosed polyneuropathy confirmed by electrodiagnosis.
* Presence of systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
* Unstable or untreated severe health conditions (such as end-stage renal disease, advanced liver failure, NYHA class IV heart failure).
* Alcohol abuse or substance dependence.
* Use of anti-inflammatory medication within 2 weeks prior to enrollment.
* Acupuncture treatment within the past 4 weeks.
* Previous treatment with thread-embedding or auricular acupuncture for any condition.
* Damaged skin in the acupuncture area or history of hypersensitivity reactions to acupuncture.
* Pregnancy or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No