Chronic Neck PainNCT04035018
Effectiveness of Pharmacopuncture for Chronic Neck Pain
A study testing pharmacopuncture therapy and Physical therapy in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 4 sites in South Korea.
Trial summary
In this study, the investigators will evaluate the efficacy and safety of pharmacopuncture therapy for chronic neck pain compared to physical therapy. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- pharmacopuncture therapy and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 18 Sep 2019to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neck pain more than 6 months
- VAS of neck pain more than 5
- Age between 17 and 70 years old
- Participants who wrote informed consent
Who cannot join
- Migration of cancer reaching to spine, fracture of spine
- Progressive neurologic deficits or severe neurologic deficits
- Cancer, fibromyalgia, RA, or goat
- Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
- Participants taking steroid, immunosuppressant, or psychotropic medication
- Hemorrhagic disease, severe diabetes or taking anticoagulant drug
Show all 12Show fewer
- Participants who took NSAIDs or pharmacopuncture within 1 week
- Pregnant or lactating women
- Participants who had undergone cervical surgery within 3 months
- Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
- Participants who can not write informed consent
- Participants who is difficult to participate in the trial according to investigator's decision
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
Haeundae Jaseng Hospital of Korean Medicine
Busan, 48102
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: A Study on the Effectiveness of Pharmacopuncture for Chronic Neck Pain: A Protocol for a Pragmatic Randomized Controlled Trial
In this study, the investigators will evaluate the efficacy and safety of pharmacopuncture therapy for chronic neck pain compared to physical therapy.
Read the detailed description
This study is prgmatic RCT of pharmacopuncture therapy for chronic neck pain compared to physical therapy.
- Conditions
- Chronic Neck Pain
- Being tested
- pharmacopuncture therapy, Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacopuncture therapyProcedure or surgery
The participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision.
Physical therapyProcedure or surgery
The participants in the control group will be receive one or more physical therapy according to the physician's decision.
| Study group | Role | What they receive |
|---|---|---|
| pharmacopuncture therapy | Experimental | The physicians will select one or more pharmacopuncture therapy for each participants. The physicians will also decide dosage and frequency of treatment according to the participant's status. Receives: Procedure: pharmacopuncture therapy |
| physical therapy | Active comparator | The physicians will select one or more physical therapy for each participants. The physicians will also decide intensity and frequency of treatment according to the participant's status. Receives: Procedure: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of neck pain
Minimum 0, Maximum 100. Higher values represent a worse outcome
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start18 Sep 2019
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, Principal investigator, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035018
- Sponsor's protocol ID
- JS-CT-2019-04
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SM, Kim SJ, Nam D, Park YC, Kim EJ, Ha IH, Lee YJ. Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs. BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.
PubMed 39725423Kim D, Kim ES, Song HJ, Park SY, Park KS, Lee YJ, Ha IH. An economic evaluation of pharmacopuncture versus usual care for chronic neck pain: a pragmatic randomized controlled trial. BMC Health Serv Res. 2023 Nov 23;23(1):1286. doi: 10.1186/s12913-023-10325-w.
PubMed 37993844Park KS, Kim S, Kim C, Seo JY, Cho H, Kim SD, Lee YJ, Lee J, Ha IH. A Comparative Study of the Effectiveness of Pharmacopuncture Therapy for Chronic Neck Pain: A Pragmatic, Randomized, Controlled Trial. J Clin Med. 2021 Dec 21;11(1):12. doi: 10.3390/jcm11010012.
PubMed 35011752
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effectiveness of Pharmacopuncture for Chronic Neck Pain: A Protocol for a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04035018
- Acronym / sponsor ID
- JS-CT-2019-04
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 29 Jul 2019 (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.
In this study, the investigators will evaluate the efficacy and safety of pharmacopuncture therapy for chronic neck pain compared to physical therapy.
Detailed description
This study is prgmatic RCT of pharmacopuncture therapy for chronic neck pain compared to physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmacopuncture therapy | Experimental | Procedure: pharmacopuncture therapyThe physicians will select one or more pharmacopuncture therapy for each participants. The physicians will also decide dosage and frequency of treatment according to the participant's status. |
| physical therapy | Active comparator | Procedure: Physical therapyThe physicians will select one or more physical therapy for each participants. The physicians will also decide intensity and frequency of treatment according to the participant's status. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neck pain more than 6 months
- VAS of neck pain more than 5
- Age between 17 and 70 years old
- Participants who wrote informed consent
Key exclusion criteria (12 listed)
- Migration of cancer reaching to spine, fracture of spine
- Progressive neurologic deficits or severe neurologic deficits
- Cancer, fibromyalgia, RA, or goat
- Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
- Participants taking steroid, immunosuppressant, or psychotropic medication
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 |
|---|---|---|
| pharmacopuncture therapyThe participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision. | Procedure or surgery | pharmacopuncture therapy |
| Physical therapyThe participants in the control group will be receive one or more physical therapy according to the physician's decision. | Procedure or surgery | physical therapy |
Primary outcome
Visual analogue scale of neck pain
Time frame: week 6
Minimum 0, Maximum 100. Higher values represent a worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 39725423Lee SM, Kim SJ, Nam D, Park YC, Kim EJ, Ha IH, Lee YJ. Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs. BMJ Open. 2024 Dec 26;14(12):e086104. doi: 10.1136/bmjopen-2024-086104.
- Derived from this study: PubMed 37993844Kim D, Kim ES, Song HJ, Park SY, Park KS, Lee YJ, Ha IH. An economic evaluation of pharmacopuncture versus usual care for chronic neck pain: a pragmatic randomized controlled trial. BMC Health Serv Res. 2023 Nov 23;23(1):1286. doi: 10.1186/s12913-023-10325-w.
- Derived from this study: PubMed 35011752Park KS, Kim S, Kim C, Seo JY, Cho H, Kim SD, Lee YJ, Lee J, Ha IH. A Comparative Study of the Effectiveness of Pharmacopuncture Therapy for Chronic Neck Pain: A Pragmatic, Randomized, Controlled Trial. J Clin Med. 2021 Dec 21;11(1):12. doi: 10.3390/jcm11010012.
- 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. This study is not recruiting at the moment.
In-Hyuk Ha principal investigator
Jaseng Hospital of Korean Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacopuncture therapy and Physical therapy in people with Chronic Neck Pain, run by Jaseng Medical Foundation at 4 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 12 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analogue scale of neck pain (time frame: week 6). 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 NCT04035018, which also lists 3 linked publications.
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 9 Jul 2020.