The Efficacy and Safety of Herbal Medicine Treatment for Obese Patients With Spinal and Joint Pain

The Efficacy and Safety of Herbal Medicine Treatment for Obese Patients With Spinal and Joint Pain: A Pragmatic Randomized Controlled Pilot Clinical Trial

This study is a pragmatic pilot randomized controlled trial aimed at investigating the effectiveness of herbal medicine treatment for obese patients with spinal and joint pain, using a control group receiving lifestyle guidance.

0. Background Obesity has been defined as a chronic disease requiring long-term treatment by the World Health Organization (WHO). Additionally, an increase in body fat is associated with a higher prevalence of musculoskeletal pain and related disorders. Therefore, this study aims to evaluate the efficacy of herbal medicine treatment by investigating whether a reduction in obesity affects spinal and joint pain in obese patients, who constitute a significant proportion of patients visiting Korean medicine clinics and hospitals for spinal and joint pain.

1. Patient Recruitment and Screening Phase

1. Patient Recruitment Forty patients meeting the inclusion/exclusion criteria will be recruited starting from the date of IRB registration. Researchers will use block randomization to allocate participants. After obtaining written consent from patients who meet the criteria, they will be assigned to the study. The probability of assignment to each group will be 1:1.
2. Allocation Concealment and Blinding Since blinding is not feasible for this study, it will be conducted as an open-label clinical trial. However, assessor blinding will be implemented. The evaluator, who will not participate in the intervention and will be blinded to group allocation, will conduct assessments in a separate space before the intervention. This role will be performed by a research nurse or a specialist in training.

2. Treatment and Evaluation Phase

1. Control and Experimental Groups The experimental group will receive herbal medicine treatment in addition to standard care, while the control group will receive lifestyle guidance only. Both groups will be provided with identical educational materials and guidance on lifestyle modifications aimed at weight loss.

   The educational materials will include information on the definition and causes of obesity, as well as explanations on weight reduction and lifestyle management applicable to various situations, including diet and exercise.

   Lifestyle guidance will be based on the provided materials. During the first visit, participants will receive comprehensive education on the study materials. Follow-up education sessions will be conducted every two weeks for a total of six weeks, during which changes in participants' symptoms will also be evaluated.

   Both groups will receive lifestyle education under identical conditions to evaluate the additional effects of herbal medicine treatment.

2. Study Duration and Observation Points The total participation period for each subject will be 12 weeks, including a 6-week treatment period and a 6-week follow-up period.

   Baseline data will be collected at the time of study enrollment (Week 0), and the primary endpoint will be at Week 6.

   Data will be collected during visits at Week 0, Week 2, and Week 4 during the treatment period, as well as during follow-up visits at Week 6 (primary endpoint), Week 8, and Week 12.

3. Data Collection for Evaluation i. Primary Outcome The primary outcome will be the BMI at Week 6, after the completion of the treatment intervention.

ii. Secondary Outcomes

Secondary outcomes will be assessed at Week 0, Week 2, Week 4, Week 6 (primary endpoint), Week 8, and Week 12. The following indicators will be evaluated:

Body fat percentage Body fat mass Skeletal muscle mass Body weight Visceral fat level Quality of life (EQ-5D-5L) IWQOL-Lite (Impact of Weight on Quality of Life - Lite) The most painful area in the spinal and joint regions NRS (Numeric Rating Scale) for pain intensity Adherence to the intervention Adverse effects

3. Follow-Up Phase After the 6-week intervention period, a 6-week follow-up will be conducted to assess changes in the participants' symptoms.

At Weeks 6, 8, and 12, evaluations will be conducted using the same parameters as during the treatment visits, including the primary outcome (BMI) and secondary outcomes (body weight, body fat percentage, body fat mass, skeletal muscle mass, EQ-5D, IWQOL-Lite, the most painful spinal/joint area, pain intensity at that site, adherence, and adverse effects). The time window for follow-up evaluations will be ±5 days for Week 6 and ±7 days for Weeks 8 and 12.

Blood tests will be conducted at Week 6, aligned with the start of herbal medicine treatment. The blood test parameters will be the same as those performed during the screening phase.

4. Monitoring

Although this is a researcher-initiated clinical study, monitoring will be conducted by a third party in accordance with the institution's HRPP (Human Research Protection Program) policy and KCGP (Korean Good Clinical Practice) guidelines. The purpose of monitoring is to ensure that the following are maintained throughout the study period and to prevent recurrence of any non-compliance through proper reporting procedures:

Monitoring intervals will be appropriately spaced, and the frequency will depend on the rate of participant enrollment and the data collected.

Inclusion Criteria:

• Patients aged 19 years or older but under 70 years.
• Individuals with a BMI of 25 kg/m² or higher, meeting the Asia-Pacific obesity criteria.
• Individuals experiencing spinal or joint pain, with the most severe pain rated as NRS 5 or higher.
• Individuals who voluntarily agree to participate in the clinical trial and sign the consent form.

Exclusion Criteria:

• Presence of findings on X-ray examination of the pain site, such as acute fractures or dislocations, requiring surgical intervention.
• Diagnosis of specific diseases that may cause secondary obesity (e.g., Cushing's syndrome, hypothyroidism, insulinoma, adult growth hormone deficiency, etc.).
• Current use of medications related to obesity treatment or a history of taking such medications within the past month.
• Presence of other chronic diseases that may interfere with treatment efficacy or interpretation of results, such as stroke, myocardial infarction, kidney disease, active hepatitis, diabetic neuropathy, dementia, epilepsy, etc.
• Current use of steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
• Unsuitability or safety concerns for herbal medicine treatment: individuals with conditions or post-surgical complications affecting drug absorption or digestion, severe liver disease, or kidney disease.
• Pregnant or planning to become pregnant, or currently breastfeeding.
• Participation in other clinical trials, except for observational studies without therapeutic intervention.
• Difficulty in providing informed consent.
• Other cases where the investigator deems participation in the clinical study inappropriate.