Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation

NCT06024460 | Recruiting

• 1 other identifier: JS-CT-2023-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized controlled study comparing non-pharmacological treatment to proactive pharmacological treatment for patient with non-acute lumbar disc herniation with moderate or higher levels of pain. The study involves 200 adult patients aged 19-69, with 50 patients from each participating hospital. Patients will be randomly assigned to either the non-pharmacological treatment group or the pharmacological treatment group 1:1 ratio. Specific interventions will be determined by doctors and Korean medicine doctors without predefined treatment strategies. The non-pharmacological treatment include acupuncture, electroacupuncture, spinal manual therapy and motion style acupuncture. The pharmacological treatment include medication prescription, injection, and nerve block. Treatment period is 8 weeks, and f/u for 3 years.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index (ODI)

  The Oswestry Disability Index (ODI) is a questionnaire used to assess the functional status and degree of disability caused by lower back pain. It consists of 10 items that evaluate various aspects of daily activities and mobility. Each item is rated on a 6-point scale, with higher scores indicating a greater level of disability. From 0 to 100. Higher scores mean a worse outcome.

  Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36

• Numeric Rating Scale for Pain of Dominant Change (NRS for DC)

  The study will evaluate the intensity of lower back pain and radiating leg pain using the Numeric Rating Scale (NRS). Patients will rate their pain levels on a scale from 0 to 10, where 0 represents no pain and 10 represents the most severe imaginable pain. The NRS for Dominant Change (NRS-DC) will be calculated as the higher value between the change in NRS scores from baseline for lower back pain and radiating leg pain. The NRS-DC will serve as a key evaluation indicator for pain intensity.

  Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

Secondary Outcomes (13)

• Recurrence

  Week 13, 26, 39, 52, Month 18, 24, 36

• Numeric Rating Scale (NRS) for Low Back Pain

  Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

• Patient Global Impression of Change (PGIC)

  Week 9, 13, 26, 39, 52, Month 18, 24, 36

• Fear-Avoidance Beliefs Questionnaire (FABQ)

  Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36

• Short Form-12 Health Survey version 2 (SF-12 v2)

  Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36

Study Arms (2)

Non-pharmacological treatment strategy

EXPERIMENTAL

Interventions: Non-pharmacological treatment include acupuncture, electroacupuncture, spinal manual therapy, and motion style acupuncture treatment. Frequency: Not specified (Twice a week recommended) Duration: Eight weeks.

Procedure: non-pharmacological treatment strategy

Pharmacological treatment strategy

ACTIVE COMPARATOR

Interventions: Active pharmacological treatment involving prescription medication, injection therapy, or other pharmacological interventions. Frequency: Not specified (Twice a week recommended) Duration: Eight weeks.

Procedure: pharmacological treatment strategy

Interventions

non-pharmacological treatment strategy PROCEDURE

Acupuncture, elctroacupuncture, spinal manual therapy, motion style acupucnture treatment

Non-pharmacological treatment strategy

pharmacological treatment strategy PROCEDURE

Prescription medication, injection therapy, nerve blocks, or other pharmacological interventions commonly used for managing lumbar disc herniation. This group is treated using the above treatment strategies, and no drug is specified.

Pharmacological treatment strategy

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 19 to 69 years.
• lower back pain that has persisted for at least 1 month.
• a Numeric Rating Scale (NRS) score of 5 or higher for either lower back pain or radiating leg pain over the past three consecutive days.
• confirmed lumbar disc herniation on MRI that can explain the lower back pain.
• who have provided written informed consent and agreed to participate in the clinical study.

You may not qualify if:

• diagnosed with specific severe diseases that could be the cause of lower back pain or leg pain (e.g., spinal metastasis, acute fractures, and spinal dislocation).
• showing progressive neurological deficits or severe neurological symptoms.
• with pain originating from soft tissue disorders other than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
• with other chronic conditions (e.g., stroke and myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy) that may interfere with the treatment effect or result interpretation.
• taking steroids, immunosuppressive drugs, psychiatric medications, or other medications that may impact the study results.
• acupuncture or nerve block treatment is inappropriate or unsafe, such as those with a history of bleeding disorders, receiving anticoagulant therapy, or diagnosed with uncontrolled diabetes.
• taken non-steroidal anti-inflammatory drugs (NSAIDs) or other pain-affecting drugs or received acupuncture treatment within the past 5 days.
• Pregnant women, those planning pregnancy, or breastfeeding women.
• within 3 months after lumbar surgery.
• who have not completed participation in another clinical study within the past month or have plans to participate in another clinical study within 6 months from the selection date or during the study participation and follow-up period.
• Inability to provide written informed consent.
• \- Other cases where the researchers determine that participation in the clinical study would be difficult.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (4)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

RECRUITING

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi-do, 14598, South Korea

RECRUITING

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

RECRUITING

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

RECRUITING

Related Publications (1)

• Kim D, Lee YJ, Yang C, Ahn YJ, Kim S, Lee Y, Cho HW, Han CH, Ha IH. Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Protocol for a Multicenter Pragmatic Trial. J Pain Res. 2025 Dec 26;18:7167-7178. doi: 10.2147/JPR.S568386. eCollection 2025.

  PMID: 41477591 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Hyuk Ha, Dr

  Jaseng Medical Foundation

  STUDY DIRECTOR

Central Study Contacts

In-Hyuk Ha, Dr

CONTACT

+82-2-2222-2740; hanihata@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The interventional study model in this study is a pragmatic, multi-centered, randomized controlled, parallel-grouped design. This means that the study will involve multiple centers, random assignment of participants into different treatment groups (non-pharmacological treatment arm and pharmacological treatment arm), and a parallel-grouped comparison of the effectiveness of the interventions. The study aims to assess the real-world effectiveness of the treatment strategies in a pragmatic setting, allowing flexibility in treatment decisions based on clinical judgment.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: September 6, 2023
• Study Start: August 9, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)