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

Lumbar Disc Herniation Clinical Trial

Official title:

Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation: a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024460
• Other study ID #: JS-CT-2023-02
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2024
• Source: Jaseng Medical Foundation
• Contact: In-Hyuk Ha, Dr
• Phone: +82-2-2222-2740
• Email: hanihata[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a pragmatic, multi-centered, randomized controlled, parallel-grouped study aiming to compare the effectiveness of a non-pharmacological treatment strategy and a active pharmacological treatment strategy in managing non-acute lumbar disc herniation with moderate or higher levels of pain persisting for more than one month in adult men and women aged 19 to 69 years.

The study will include 200 patients with lumbar disc herniation, with 50 patients from each of the participating hospitals (Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Haeundae Jaseng Hospital of Korean Medicine, competitively recruited). The patients will be assigned in a 1:1 ratio to receive either non-pharmacological treatment (100 patients) or active pharmacological treatment (100 patients) in a pragmatic randomized controlled design. The specific interventions for each group will be determined based on clinical judgment by the doctors and Korean medicine doctors involved in the study, without predefining the treatment strategies. The treatment methods, including acupuncture, electroacupuncture, spinal maunal therapy and motion style acupuncture, will be recorded in the case report form for comparative analysis.

For the non-pharmacological treatment group, patients will be recommended to receive non-pharmacological treatment based on TKM. The frequency and specifics of the treatment will be determined by the clinical judgment of the doctors and Korean medicine doctors based on the patient's symptoms, MRI images, and clinical improvement. The treatment will be conducted twice a week for a total of eight weeks, but the frequency may be adjusted according to the patient's condition. Concurrent therapies and adjuvant therapies can be freely chosen by the patients, and the details will be recorded in the case report form.

For the pharmacological treatment group, patients will be educated about proactive pharmacological treatment and recommended to receive pharmacological treatment. The specific pharmacological interventions, such as prescription medication, injection therapy, and nerve block, will be determined by the doctors based on the patient's symptoms, imaging results, and clinical judgment. The details of the prescribed medication, dosage, administration route, and duration will be recorded in the case report form. Similar to the non-pharmacological treatment group, concurrent therapies and adjuvant therapies can be chosen by the patients, and the details will be recorded.

The treatment frequency for the pharmacological treatment group will also be twice a week for a total of eight weeks, with adjustments based on the patient's condition. The effectiveness of the treatment strategies will be assessed through weekly evaluations of the patients' symptoms and treatment progress.

It should be noted that patients are not obligated to strictly follow the assigned treatment strategy, as this is a study recommending a particular treatment strategy rather than enforcing it as a protocol violation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Procedure:
• non-pharmacological treatment strategy
Acupuncture, elctroacupuncture, spinal manual therapy, motion style acupucnture treatment
• pharmacological treatment strategy
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.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi
Korea, Republic of	Haeundae Jaseng Hospital of Korean Medicine	Busan
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recurrence	This study will confirm the recurrence of symptoms in patients through a yes or no response.	Week 13, 26, 39, 52, Month 18, 24, 36
Secondary	Numeric Rating Scale (NRS) for Low Back Pain	NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participants are asked to report their low back pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable.	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
Secondary	Patient Global Impression of Change (PGIC)	Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)	Week 9, 13, 26, 39, 52, Month 18, 24, 36
Secondary	Fear-Avoidance Beliefs Questionnaire (FABQ)	The fear-avoidance belief questionnaire (FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.; Minimum 0 to maximum 66 scores. Higher score means a worse outcome.	Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
Secondary	Short Form-12 Health Survey version 2 (SF-12 v2)	The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.; Ranging from 0 to 100, higher score means a better outcome.	Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
Secondary	EuroQol-5 Dimension (EQ-5D-5L)	The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) Ranging from 0 to 1, higher score means a better outcome.	Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
Secondary	Credibility and Expectancy	The study will measure the level of trust and expectation regarding the effectiveness of the treatment through two questions: On a scale from 0 to 10, how much do you believe that traditional herbal medicine treatment will alleviate your symptoms? On a scale from 0 to 10, how much do you believe that drug therapy will alleviate your symptoms? 0 indicates no belief or expectation, and 10 indicates full belief and high expectation.	Baseline
Secondary	Intention to Treat	Evaluate participants' intentions if they are willing to receive non-pharmacological treatment strategies or pharmacological treatment strategies in the future on a scale from 0 to 9. 0 indicates no intention, and 10 indicates full belief and high intention.	Week 9
Secondary	Work Productivity and Activity Impairment-Specific Health Problem	Productivity loss will be assesed by WPAI-SHP. Through the WPAI questionnaire, the overall work productivity, which is a concept combining absenteesim and presenteeism, as well as employment will be investigated and used as outcomes.	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
Secondary	Classification of Disc Degeneration	Classify the degree of disc degeneration based on the Pfirrmann grading system.	Week 1, 26, 52, Month 24, 36
Secondary	Stages to a Disc Herniation	Classify the stage of disc herniation as bulging, protrusion, extrusion, or sequestration/migration.	Week 1, 26, 52, Month 24, 36
Secondary	Herniated Disc Areas	Measure the area of the most significant transverse plane slice of the herniated disc on MRI.	Week 1, 26, 52, Month 24, 36
Secondary	Cost Data Survey	Measure various cost items related to the treatment, including medical costs, non-medical costs, time costs, and productivity loss costs.	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36