Neck PainNCT06591221
The Effectiveness of Chuna Maintenance Therapy for Chronic Bothersome Neck Pain
A study testing Chuna Maintenance Therapy in people with Neck Pain and Chronic Pain, run by Jaseng Medical Foundation at 7 sites in South Korea.
Trial summary
This study is a pragmatic randomized controlled study that assessed 250 subjects complaining of chronic bothersome neck pain with mild discomfort in a 1:1 ratio: chuna maintenance therapy group (125 subjects, 1 time/2 weeks, total 20 weeks) and lifestyle management \& self-exercise group (125 subjects, exercise method… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Chuna Maintenance Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 7 Jul 2024to 31 Mar 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19 or older but under 70.
- Neck pain with pain duration of 12 months or longer
- NRS of neck pain over the past month is 2 or more but less than 4
- Patients who have agreed to trial participation and provided written informed consent
Who cannot join
- Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
- Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
- Patients whose pain is due to soft tissue disease not the spine (e.g. tumors, fibromyalgia, rheumatoid arthritis, gout)
- Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcome (e.g. stroke and myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
- Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
- Pregnant patients or patients with plans of pregnancy or lactating patients
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- Patients within 3 months after cervical surgery
- Patients with experience of participating in another clinical study within 1 month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the participation date
- Patients having difficult to completing the written informed consent
- Patients who are deemed unsuitable by the researchers
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si
Daejeon Jaseng Hospital of Korean Medicine
Daejeon
Haeundae Jaseng Hospital of Korean Medicine
Haeundae
College of Korean Medicine, Kyung Hee University
Seoul
Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University
Seoul
Jaseng Hospital of Korean Medicine
Seoul
School of Korean Medicine, Pusan National University
Yangsan
About this study
Official title: Evaluation of the Effectiveness of Manual Maintenance Therapy (Chuna Maintenance Therapy) for Chronic Bothersome Neck Pain : a Multi-centered, Pragmatic Randomized Controlled Study
This study is a pragmatic randomized controlled study that assessed 250 subjects complaining of chronic bothersome neck pain with mild discomfort in a 1:1 ratio: chuna maintenance therapy group (125 subjects, 1 time/2 weeks, total 20 weeks) and lifestyle management \& self-exercise group (125 subjects, exercise method education 1 time/4 weeks, total 20 weeks).
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Chuna Maintenance Therapy
- Keywords
- Chuna therapy, Manual therapy, Chronic neck pain
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chuna Maintenance TherapyProcedure or surgery
it is conducted every two weeks for a total of 20 weeks for individuals. The technique follows the guidelines of the Society of Chuna Manual Medicine and is based on Chuna Medicine (2.5th edition), which is utilized as a textbook in Korean Medicine colleges.
The treatment is selectively administered based on the clinical judgment of the practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Chuna maintenance therapy group | Experimental | This group will receive chuna therapy determined by the clinician based on the subject's symptoms, degree of improvement, etc. (1 time/2 weeks, total 20 weeks) Receives: Procedure: Chuna Maintenance Therapy |
| Lifestyle management & self-exercise group | Other | This group will perform lifestyle management and daily self-exercise. The exercise education will be performed per 4 weeks for total 20 weeks. Receives: Procedure: Chuna Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numeric rating scale)
Ranging 0-10 likert scale (higher=worse)
Measured: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
NDI (Neck disability index)
Each of the 10 items scores from 0 to 5, The maximum score is 50 (higher=worse)
Measured: Wk 1, 5, 9, 13, 17, 21, 25
Secondary outcomes (8)
VAS(Visual analogue scale) for pain
Ranging 0-10cm scale (higher=worse)
Measured: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Number of days with bothersome neck pain
Measured: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Recurrence
Measured: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
PGIC (Patient Global Impression of Change)
PGIC is a 7 point scale depicting a patient's rating of overall improvement (higher=worse)
Measured: Wk 21, 25
EQ-5D-5L( The 5-level EuroQol-5)
5 items for self-rating of overall health (lower=worse)
Measured: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
HINT-8 (health-related quality of life instrument-8)
8 items for self-rating of overall health (lower=worse)
Measured: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Rating for Credibility and Expectancy of the treatment
Ranging 1-9 likert scale (higher=more credible, positive results are expected)
Measured: Once at screening procedure
Drug consumption history
Whether medication was used (Y/N)
Measured: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Jul 2024
- Primary completion3 Feb 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591221
- Sponsor's protocol ID
- JS-CT-2024-02
- Status last verified
- May 2026
- First submitted
- 31 Aug 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yun JM, Kim JY, Lee SH, Lee YJ, Heo I, Shin WC, Cho JH, Seo BK, Ha IH. Multi-Institutional Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of Manual Maintenance Therapy for Chronic Bothersome Neck Pain. J Pain Res. 2026 Mar 18;19:577619. doi: 10.2147/JPR.S577619. eCollection 2026.
PubMed 41873381
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Manual Maintenance Therapy (Chuna Maintenance Therapy) for Chronic Bothersome Neck Pain : a Multi-centered, Pragmatic Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06591221
- Acronym / sponsor ID
- JS-CT-2024-02
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- Chuna therapy, Manual therapy, Chronic neck pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 Sep 2024 (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 randomized controlled study that assessed 250 subjects complaining of chronic bothersome neck pain with mild discomfort in a 1:1 ratio: chuna maintenance therapy group (125 subjects, 1 time/2 weeks, total 20 weeks) and lifestyle management \& self-exercise group (125 subjects, exercise method education 1 time/4 weeks, total 20 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chuna maintenance therapy group | Experimental | Procedure: Chuna Maintenance TherapyThis group will receive chuna therapy determined by the clinician based on the subject's symptoms, degree of improvement, etc. (1 time/2 weeks, total 20 weeks) |
| Lifestyle management & self-exercise group | Other | Procedure: Chuna Maintenance TherapyThis group will perform lifestyle management and daily self-exercise. The exercise education will be performed per 4 weeks for total 20 weeks. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (10 listed)
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 |
|---|---|---|
| Chuna Maintenance Therapyit is conducted every two weeks for a total of 20 weeks for individuals. The technique follows the guidelines of the Society of Chuna Manual Medicine and is based on Chuna Medicine (2.5th edition), which is utilized as a textbook in Korean Medicine colleges. The treatment is selectively administered based on the clinical judgment of the practitioner. | Procedure or surgery | Chuna maintenance therapy group, Lifestyle management & self-exercise group |
Primary outcome
NRS (Numeric rating scale)
Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Ranging 0-10 likert scale (higher=worse)
NDI (Neck disability index)
Time frame: Wk 1, 5, 9, 13, 17, 21, 25
Each of the 10 items scores from 0 to 5, The maximum score is 50 (higher=worse)
8 secondary outcomes
VAS(Visual analogue scale) for pain
Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Number of days with bothersome neck pain
Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Recurrence
Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
PGIC (Patient Global Impression of Change)
Time frame: Wk 21, 25
EQ-5D-5L( The 5-level EuroQol-5)
Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
HINT-8 (health-related quality of life instrument-8)
Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
Rating for Credibility and Expectancy of the treatment
Time frame: Once at screening procedure
Drug consumption history
Time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25
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 28 May 2026.
- Derived from this study: PubMed 41873381Yun JM, Kim JY, Lee SH, Lee YJ, Heo I, Shin WC, Cho JH, Seo BK, Ha IH. Multi-Institutional Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of Manual Maintenance Therapy for Chronic Bothersome Neck Pain. J Pain Res. 2026 Mar 18;19:577619. doi: 10.2147/JPR.S577619. eCollection 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chuna Maintenance Therapy in people with Neck Pain and Chronic Pain, run by Jaseng Medical Foundation at 7 sites 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 10 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
NRS (Numeric rating scale) (time frame: Wk 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25). 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?
On the ClinicalTrials.gov record for NCT06591221, which also lists 1 linked publication.
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 28 May 2026.