Chronic Low-back Pain (cLBP)NCT07058376
Clinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain
A study testing Herbal Medicine Strategy and Standard Korean Medicine Treatment in people with Chronic Low-back Pain (cLBP), run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This study is a pragmatic multicenter randomized controlled trial evaluating the effectiveness and safety of herbal medicine strategy for chronic low back pain, using standard Korean medicine treatment as the control. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Herbal Medicine Strategy and Standard Korean Medicine Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals experiencing low back pain for more than 3 months.
- Low back pain Numeric Rating Scale (NRS) score of 5 or higher.
- Aged 19 years or older and younger than 70 years.
- Individuals who voluntarily agree to participate in the clinical study and provide written informed consent.
Who cannot join
- Diagnosed with serious underlying conditions that may cause low back or radiating leg pain (e.g., spinal metastases, acute fractures, or vertebral dislocations).
- Presence of progressive neurological deficits or severe neurological symptoms.
- Pain primarily caused by non-spinal soft tissue conditions (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
- Presence of other chronic diseases that may interfere with the treatment outcomes or their interpretation (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy).
- Currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
- Contraindications to acupuncture treatment or conditions making acupuncture unsafe: bleeding disorders, current anticoagulant therapy, or severe diabetes with high risk of infection.
Show all 13Show fewer
- Contraindications to herbal medicine or conditions making its use unsafe: disorders or post-surgical conditions affecting drug absorption, severe hepatic or renal disease (AST, ALT, γ-GTP, or serum creatinine more than twice the upper normal limit at screening).
- Use of pain-altering medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or receipt of acupuncture treatment within 1 week prior to screening.
- Pregnant or breastfeeding women, or those planning pregnancy.
- Patients who underwent lumbar spine surgery within the last 3 months.
- Participation in another clinical trial within 1 month prior to screening, or plans to participate in another clinical trial during this study or within 6 months of screening.
- Difficulty in providing written informed consent.
- Any other condition judged by the investigator to make participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Clinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain : A Prospective, Multicenter, Pragmatic Randomized Clinical Study
This study is a pragmatic multicenter randomized controlled trial evaluating the effectiveness and safety of herbal medicine strategy for chronic low back pain, using standard Korean medicine treatment as the control.
Read the detailed description
- Background Chronic low back pain (CLBP) is a common musculoskeletal disorder often managed in Korean medicine. This study aims to evaluate the effectiveness and safety of herbal medicine strategies for CLBP within a real-world clinical setting. It was initiated as part of a national research project to generate evidence for insurance coverage of herbal prescriptions.
- Patient Recruitment and Screening Phase A total of 150 patients with CLBP lasting more than 3 months will be recruited across seven Korean medicine hospitals. Patients will be randomly assigned (1:1) to either the herbal medicine strategy group or the standard Korean medicine treatment group. Randomization will be prospective and pragmatic, with no pre-specified protocol for individual treatments.
- Treatment and Evaluation Phase Experimental Group (Herbal Medicine Strategy): Participants receive individualized herbal prescriptions based on clinical judgment. Medication is prescribed every 10 days for a total of 30 days. Control Group (Standard KM Treatment): Participants receive acupuncture, electroacupuncture, cupping, moxibustion, infrared therapy, and physical therapy twice weekly for 5 weeks, with slight variations allowed based on symptom severity. Treatment details and frequencies will be recorded in CRFs and assessed during and after the intervention.
- Follow-Up Phase Participants will be followed up after the treatment period to assess outcomes. Evaluation includes pain intensity, affected areas, quality of life, and treatment adherence.
- Monitoring Although the study is investigator-initiated, third-party monitoring will be conducted in accordance with HRPP and Korean GCP guidelines to ensure protocol compliance and data integrity.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Herbal Medicine Strategy, Standard Korean Medicine Treatment
- Keywords
- herbal medicine, chronic back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal Medicine StrategyProcedure or surgery
A pragmatic intervention involving tailored herbal prescriptions created by Korean medicine doctors. The specific composition, dose, and duration of herbal medicine vary per patient, and prescriptions are adjusted according to clinical response.
Standard Korean Medicine TreatmentProcedure or surgery
This includes the application of Korean medical procedures widely used for chronic low back pain:
Acupuncture: Insertion of needles at 10-20 selected acupoints for 10-15 minutes.
Electroacupuncture: Electrical stimulation at 3 Hz to 4 acupoints for 10-15 minutes.
Infrared Therapy: Application of infrared rays from 30 cm for 10-15 minutes.
Cupping: Wet or dry cupping at 2-4 points on the lower back.
Moxibustion: Applied to two points near the painful area at 43±1°C for 10-15 minutes.
Physical Therapy (ICT or TENS): Applied for 10-15 minutes focusing on the quadratus lumborum.
Treatment frequency is 2 times/week for 5 weeks, but may be adjusted to 1-3 times/week depending on symptoms. Total number of sessions is limited to 10.
| Study group | Role | What they receive |
|---|---|---|
| Herbal Medicine Strategy Group | Experimental | Participants in this group will receive individualized herbal medicine prescriptions tailored to their clinical condition (symptoms, imaging, and response to treatment). Prescriptions, including type, dosage, and frequency, are determined by Korean medicine doctors based on clinical judgment. The herbal medicine will be taken orally for a total of 30 days, prescribed every 10 days over three clinic visits. All prescription details will be recorded in the CRF. Receives: Procedure: Herbal Medicine Strategy |
| Standard Korean Medicine Treatment Group | Active comparator | Participants in this group will receive standard Korean medicine treatments for chronic low back pain, including acupuncture, electroacupuncture, cupping, infrared therapy, moxibustion, and physical therapy. Treatments are provided twice weekly for 5 weeks (maximum 10 sessions), with slight adjustments allowed depending on symptom severity. Treatment protocols are based on clinician judgment, and all interventions and points used are recorded. Receives: Procedure: Standard Korean Medicine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Back Pain Numeric Rating Scale (NRS)
The primary outcome measure will be the change in the NRS score between Baseline and Week 7, which corresponds to the first follow-up visit after the end of treatment.
The intensity of low back pain over the past week will be assessed using the NRS. In this scale, patients select a number from 0 to 10 that best represents their current level of discomfort (0 indicates no pain, and 10 indicates the worst pain imaginable).
Measured: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
Oswestry Disability Index (ODI)
The primary outcome measure will be the change in the ODI score between Baseline and Week 7, which corresponds to the first follow-up visit after the end of treatment.
The functional status of participants will be evaluated using the ODI questionnaire, which was developed to assess the degree of disability caused by low back pain. The ODI consists of 10 items, each rated on a 6-point scale from 0 to 5. The total score is summed and then divided by the maximum possible score (50 points for 10 items) to calculate a percentage. A higher percentage indicates a greater level of disability. A validated Korean version of the ODI will be used in this study.
Measured: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
Secondary outcomes (10)
Radiating Leg Pain Numeric Rating Scale (NRS)
The intensity of radiating leg pain over the past week will be assessed using the NRS. Participants will select a number from 0 to 10 that best represents their current level of discomfort (0 indicates no pain, and 10 indicates the most severe discomfort imaginable).
Measured: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
Low Back Pain and Radiating Leg Pain Visual Analogue Scale (VAS)
The VAS consists of a 100 mm horizontal line where one end represents "no pain" and the other end represents "worst pain imaginable." Participants will mark a point on the line corresponding to the intensity of their low back pain and radiating leg pain during the past week.
Measured: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26
Roland-Morris Disability Questionnaire-6 (RMDQ-6)
The RMDQ-6 is a validated short-form version of the Roland-Morris Disability Questionnaire-24 (RMDQ-24) used to rapidly assess disability related to low back pain. It includes 6 items, and participants will respond based on their current condition. Higher scores indicate greater disability.
Measured: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26
Patient Global Impression of Change (PGIC)
The PGIC is a 7-point scale used to subjectively assess the patient's overall impression of improvement. The scale includes the following categories:
- = Very much improved,
- = Much improved,
- = Minimally improved,
- = No change,
- = Minimally worse,
- = Much worse,
- = Very much worse.
Measured: Week 7
EQ-5D-5L (EuroQol-5 Dimension, 5-Level)
The EQ-5D-5L is a widely used instrument for assessing health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has five levels of response. Weighted values are applied to each level to compute an index score representing the individual's overall health state.
Measured: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26
Health-related Quality of Life Instrument with 8 Items (HINT-8)
The HINT-8 is a Korean-specific instrument developed to measure health-related quality of life, covering physical, social, mental, and positive health dimensions. It includes 8 items: climbing stairs, pain, energy, work, depression, memory, sleep, and happiness.
Participants will choose one of four response levels per item. For example, in the stair-climbing item:
- = No difficulty,
- = Some difficulty,
- = Severe difficulty,
- = Unable to climb stairs.
For depression:
- = Not depressed at all,
- = Occasionally depressed,
- = Frequently depressed,
- = Always depressed.
Measured: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26
Patient Health Questionnaire-15 (PHQ-15)
The PHQ-15 is a validated Korean version of a 15-item questionnaire derived from the Patient Health Questionnaire (PHQ) used to assess general health status and somatic symptoms over the past 4 weeks. Each item is rated on a 3-point scale:
0 = Not bothered at all,
- = Bothered a little,
- = Bothered a lot.
The total score ranges from 0 to 30 and reflects symptom severity:
0-4 = Minimal, 5-9 = Mild, 10-14 = Moderate, 15-30 = Severe. PHQ-15 is widely used to assess somatic symptom burden and is helpful in evaluating depression and somatoform disorders.
Measured: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26
Credibility and Expectancy
Treatment expectation will be assessed using a 9-point Likert scale. At the screening visit, participants will be asked:
"How much do you think traditional Korean medicine treatment will relieve your symptoms?"
Response options range from:
1 = Not at all, 5 = Somewhat, 9 = Very much.
Measured: Screening Visit
Economic evaluation question
Cost data will be collected using a structured questionnaire designed to measure direct medical costs (e.g., medical services), non-medical costs (e.g., transportation, caregiver expenses), informal medical costs (e.g., health supplements, devices), and productivity losses. Productivity loss will be evaluated using the Work Productivity and Activity Impairment (WPAI) questionnaire, and economic costs will be estimated for cost-effectiveness analysis.
Measured: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26
Drug Consumption
Information on medications taken during the study period for current medical conditions will be collected at each visit, including drug name and dosage. Additionally, other treatments such as physical therapy or injections will be recorded by frequency.
Measured: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start31 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, PhD, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058376
- Sponsor's protocol ID
- JS-CT-2024-06
- Status last verified
- Nov 2025
- First submitted
- 1 Jul 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain : A Prospective, Multicenter, Pragmatic Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07058376
- Acronym / sponsor ID
- JS-CT-2024-06
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- herbal medicine, chronic back pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pragmatic multicenter randomized controlled trial evaluating the effectiveness and safety of herbal medicine strategy for chronic low back pain, using standard Korean medicine treatment as the control.
Detailed description
- Background Chronic low back pain (CLBP) is a common musculoskeletal disorder often managed in Korean medicine. This study aims to evaluate the effectiveness and safety of herbal medicine strategies for CLBP within a real-world clinical setting. It was initiated as part of a national research project to generate evidence for insurance coverage of herbal prescriptions.
- Patient Recruitment and Screening Phase A total of 150 patients with CLBP lasting more than 3 months will be recruited across seven Korean medicine hospitals. Patients will be randomly assigned (1:1) to either the herbal medicine strategy group or the standard Korean medicine treatment group. Randomization will be prospective and pragmatic, with no pre-specified protocol for individual treatments.
- Treatment and Evaluation Phase Experimental Group (Herbal Medicine Strategy): Participants receive individualized herbal prescriptions based on clinical judgment. Medication is prescribed every 10 days for a total of 30 days. Control Group (Standard KM Treatment): Participants receive acupuncture, electroacupuncture, cupping, moxibustion, infrared therapy, and physical therapy twice weekly for 5 weeks, with slight variations allowed based on symptom severity. Treatment details and frequencies will be recorded in CRFs and assessed during and after the intervention.
- Follow-Up Phase Participants will be followed up after the treatment period to assess outcomes. Evaluation includes pain intensity, affected areas, quality of life, and treatment adherence.
- Monitoring Although the study is investigator-initiated, third-party monitoring will be conducted in accordance with HRPP and Korean GCP guidelines to ensure protocol compliance and data integrity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal Medicine Strategy Group | Experimental | Procedure: Herbal Medicine StrategyParticipants in this group will receive individualized herbal medicine prescriptions tailored to their clinical condition (symptoms, imaging, and response to treatment). Prescriptions, including type, dosage, and frequency, are determined by Korean medicine doctors based on clinical judgment. The herbal medicine will be taken orally for a total of 30 days, prescribed every 10 days over three clinic visits. All prescription details will be recorded in the CRF. |
| Standard Korean Medicine Treatment Group | Active comparator | Procedure: Standard Korean Medicine TreatmentParticipants in this group will receive standard Korean medicine treatments for chronic low back pain, including acupuncture, electroacupuncture, cupping, infrared therapy, moxibustion, and physical therapy. Treatments are provided twice weekly for 5 weeks (maximum 10 sessions), with slight adjustments allowed depending on symptom severity. Treatment protocols are based on clinician judgment, and all interventions and points used are recorded. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals experiencing low back pain for more than 3 months.
- Low back pain Numeric Rating Scale (NRS) score of 5 or higher.
- Aged 19 years or older and younger than 70 years.
- Individuals who voluntarily agree to participate in the clinical study and provide written informed consent.
Key exclusion criteria (13 listed)
- Diagnosed with serious underlying conditions that may cause low back or radiating leg pain (e.g., spinal metastases, acute fractures, or vertebral dislocations).
- Presence of progressive neurological deficits or severe neurological symptoms.
- Pain primarily caused by non-spinal soft tissue conditions (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
- Presence of other chronic diseases that may interfere with the treatment outcomes or their interpretation (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy).
- Currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal Medicine StrategyA pragmatic intervention involving tailored herbal prescriptions created by Korean medicine doctors. The specific composition, dose, and duration of herbal medicine vary per patient, and prescriptions are adjusted according to clinical response. | Procedure or surgery | Herbal Medicine Strategy Group |
| Standard Korean Medicine TreatmentThis includes the application of Korean medical procedures widely used for chronic low back pain: Acupuncture: Insertion of needles at 10-20 selected acupoints for 10-15 minutes. Electroacupuncture: Electrical stimulation at 3 Hz to 4 acupoints for 10-15 minutes. Infrared Therapy: Application of infrared rays from 30 cm for 10-15 minutes. Cupping: Wet or dry cupping at 2-4 points on the lower back. Moxibustion: Applied to two points near the painful area at 43±1°C for 10-15 minutes. Physical Therapy (ICT or TENS): Applied for 10-15 minutes focusing on the quadratus lumborum. Treatment frequency is 2 times/week for 5 weeks, but may be adjusted to 1-3 times/week depending on symptoms. Total number of sessions is limited to 10. | Procedure or surgery | Standard Korean Medicine Treatment Group |
Primary outcome
Low Back Pain Numeric Rating Scale (NRS)
Time frame: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
The primary outcome measure will be the change in the NRS score between Baseline and Week 7, which corresponds to the first follow-up visit after the end of treatment. The intensity of low back pain over the past week will be assessed using the NRS. In this scale, patients select a number from 0 to 10 that best represents their current level of discomfort (0 indicates no pain, and 10 indicates the worst pain imaginable).
Oswestry Disability Index (ODI)
Time frame: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
The primary outcome measure will be the change in the ODI score between Baseline and Week 7, which corresponds to the first follow-up visit after the end of treatment. The functional status of participants will be evaluated using the ODI questionnaire, which was developed to assess the degree of disability caused by low back pain. The ODI consists of 10 items, each rated on a 6-point scale from 0 to 5. The total score is summed and then divided by the maximum possible score (50 points for 10 items) to calculate a percentage. A higher percentage indicates a greater level of disability. A validated Korean version of the ODI will be used in this study.
10 secondary outcomes
Radiating Leg Pain Numeric Rating Scale (NRS)
Time frame: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
Low Back Pain and Radiating Leg Pain Visual Analogue Scale (VAS)
Time frame: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26
Roland-Morris Disability Questionnaire-6 (RMDQ-6)
Time frame: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26
Patient Global Impression of Change (PGIC)
Time frame: Week 7
EQ-5D-5L (EuroQol-5 Dimension, 5-Level)
Time frame: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26
Health-related Quality of Life Instrument with 8 Items (HINT-8)
Time frame: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26
Credibility and Expectancy
Time frame: Screening Visit
Economic evaluation question
Time frame: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26
Drug Consumption
Time frame: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In-Hyuk Ha, PhD principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Medicine Strategy and Standard Korean Medicine Treatment in people with Chronic Low-back Pain (cLBP), run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Back Pain Numeric Rating Scale (NRS) (time frame: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.