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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Herbal medicine treatment is a treatment using complex extract of medicinal herbs prescribed by a Korean medicine doctor who has completed specialized education to diagnose the health condition and symptoms of patients
Educational materials will be distributed, and education on daily life management for weight loss will be conducted. The educational materials consist of information on the definition and causes of obesity, explanations on weight reduction and daily life management applicable to various situations such as exercise and diet, and the effects of these practices.
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea
BMI(Body Mass Index)
Body weight (kg) divided by the square of height (m) is used as a diagnostic criterion for obesity. Based on the significant increase in obesity-related diseases associated with body mass index (BMI), the Asia-Pacific region and the Korean Society for the Study of Obesity have established the criteria as follows: a BMI of 23 kg/m² or higher is classified as overweight or pre-obesity, and a BMI of 25 kg/m² or higher is classified as obesity.
Time frame: Change from baseline to Week 6
Body Fat Percentage
Body fat percentage (percent body fat, PBF, %fat) is the proportion of body fat relative to total body weight. Obesity classification based on body fat percentage is as follows: for men, less than 10.0% is classified as underweight, 10.0-20.0% as normal, 20.0-25.0% as overweight, and 25.0% or higher as obesity; for women, less than 18.0% is classified as underweight, 18.0-28.0% as normal, 28.0-33.0% as overweight, and 33.0% or higher as obesity.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Body fat mass
Body fat mass refers to the absolute amount of fat in the body, measured in kilograms (kg). It represents the total weight of fat tissue in the body and is an important indicator for assessing obesity and overall body composition. Unlike body fat percentage, which is a relative measure, body fat mass provides an absolute value, making it useful for tracking changes in fat levels over time, especially during weight management or fitness programs.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Skeletal Muscle Mass
Skeletal muscle mass refers to the total weight of skeletal muscles in the body, typically measured in kilograms (kg). Skeletal muscles are responsible for voluntary movements and play a crucial role in physical activity, metabolism, and overall health. This measurement is used to assess muscle development and monitor changes due to exercise, aging, or medical conditions
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Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Body weight
Body weight refers to the total mass of an individual's body, typically measured in kilograms (kg) or pounds (lbs). It includes the combined weight of bones, muscles, fat, organs, fluids, and other tissues. Body weight is a fundamental parameter for assessing overall health and is often used in conjunction with other measurements, such as body fat percentage, skeletal muscle mass, and BMI, to evaluate physical fitness, nutritional status, and the risk of developing obesity-related diseases.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Visceral fat level
Visceral fat level refers to the amount of fat stored around internal organs in the abdominal cavity, such as the liver, pancreas, and intestines. In InBody devices, visceral fat level is expressed on a scale ranging from 1 to 20, where a level below 10 is generally considered healthy, while a level of 10 or higher indicates excessive visceral fat that may require management.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
5-Level EuroQol-5 Dimension (EQ-5D-5L)
The 5-Level EuroQol-5 Dimension (EQ-5D-5L) is one of the most widely used indirect measurement methods for calculating the quality weight of a specific health state. It evaluates health status from multiple perspectives and utilizes pre-assigned preference scores for each functional level to indirectly calculate the quality weight of a particular health condition. The EQ-5D-5L consists of five items, each addressing the degree of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is assigned a specific weight based on its level, and a preference score calculation formula is provided using these weights and constants.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
IWQOL-Lite (Impact of Weight on Quality of Life - Lite)
The IWQOL-Lite is a questionnaire tool developed to assess the impact of weight on quality of life and is primarily used in obesity research and evaluating the effectiveness of weight loss treatments. It is a simplified version of the IWQOL (Impact of Weight on Quality of Life) and consists of 31 items. The questionnaire is divided into five subscales: physical function, self-esteem, sexual life, interpersonal stress, and work-related activities.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Areas of Spinal and Joint Pain
To investigate the primary pain areas in the spinal and joint regions of obese patients, the severity of pain in the single most painful area is assessed.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
NRS (Numeric Rating Scale)
The Numeric Rating Scale (NRS) is used to assess the severity of pain in the single most painful area. Patients rate their pain on a scale from 0 to 10, where 0 represents "no pain at all" and 10 represents "the worst pain imaginable or unbearable pain." This scale provides a simple and effective way to quantify pain levels for clinical evaluation and treatment planning.
Time frame: Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Adherence
To evaluate treatment adherence, for participants in the herbal medicine treatment group, the total number of prescribed herbal medicine packs and the number of consumed packs are assessed from Week 0 to Week 6 and recorded in the Case Report Form (CRF). Additionally, for all participants, the number of days they adhered to dietary and exercise regimens is also investigated and documented in the CRF. This comprehensive adherence evaluation helps ensure accurate monitoring of participants' compliance with treatment protocols and lifestyle modifications.
Time frame: Week 2, Week 4, Week 6