Chronic Low-back PainNCT04576520
PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
A study testing pharmacopuncture therapy and physical therapy in people with Chronic Low-back Pain, run by Jaseng Medical Foundation at 4 sites in South Korea.
Trial summary
This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back 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
- 32 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 13 Oct 2020to 26 Mar 2021
- 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
- low back pain for more than 6 months
- Visual Analogue Scale (VAS) of low back pain is more than 5
- 19-70 years old
- participants who agreed and wrote informed consents
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
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.
Read the detailed description
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.
- Conditions
- Chronic Low-back 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
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
physical therapyProcedure or surgery
This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
| Study group | Role | What they receive |
|---|---|---|
| pharmacopuncture therapy | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions. Receives: Procedure: pharmacopuncture therapy |
| physical therapy | Active comparator | The physicians will choose the type and time of physical therapy according to participants' conditions. Receives: Procedure: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) of low back pain
Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Measured: Change from baseline VAS at week 6
Secondary outcomes (7)
Visual analogue scale (VAS) of leg radiating pain
Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Measured: Week 1, 2, 3, 4, 5, 6, 10, 16
Numeric rating scale (NRS) of low back pain and leg radiating pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: Week 1, 2, 3, 4, 5, 6, 10, 16
Oswestry Disability Index (ODI)
ODI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome).
Measured: Week 1, 6, 10, 16
Korean version of the Roland-Morris Disability Questionnaire (RMDQ)
The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability).
Measured: Week 1, 6, 10, 16
Patient Global Impression of Change (PGIC)
Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
Measured: Week 6, 10, 16
Short Form-12 Health Survey version 2 (SF-12 v2)
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Measured: Week 1, 6, 10, 16
EuroQol-5 Dimension (EQ-5D-5L)
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
Measured: Week 1, 6, 10, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start13 Oct 2020
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back 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
- 32 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, Ph.D, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576520
- Sponsor's protocol ID
- JS-CT-2020-09
- Status last verified
- Aug 2021
- First submitted
- 29 Sep 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
- ClinicalTrials.gov ID
- NCT04576520
- Acronym / sponsor ID
- JS-CT-2020-09
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 6 Oct 2020 (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 is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.
Detailed description
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.
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 choose the type and volume of pharmacopuncture according to participants' conditions. |
| physical therapy | Active comparator | Procedure: physical therapyThe physicians will choose the type and time of physical therapy according to participants' conditions. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- low back pain for more than 6 months
- Visual Analogue Scale (VAS) of low back pain is more than 5
- 19-70 years old
- participants who agreed and wrote informed consents
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 therapyThis is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions. | Procedure or surgery | pharmacopuncture therapy |
| physical therapyThis is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions. | Procedure or surgery | physical therapy |
Primary outcome
Visual analogue scale (VAS) of low back pain
Time frame: Change from baseline VAS at week 6
Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
7 secondary outcomes
Visual analogue scale (VAS) of leg radiating pain
Time frame: Week 1, 2, 3, 4, 5, 6, 10, 16
Numeric rating scale (NRS) of low back pain and leg radiating pain
Time frame: Week 1, 2, 3, 4, 5, 6, 10, 16
Oswestry Disability Index (ODI)
Time frame: Week 1, 6, 10, 16
Korean version of the Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Week 1, 6, 10, 16
Patient Global Impression of Change (PGIC)
Time frame: Week 6, 10, 16
Short Form-12 Health Survey version 2 (SF-12 v2)
Time frame: Week 1, 6, 10, 16
EuroQol-5 Dimension (EQ-5D-5L)
Time frame: Week 1, 6, 10, 16
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 30 Aug 2021.
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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, Ph.D study director
Jaseng Medical Foundation
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 Low-back 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 30 Aug 2021. 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 (VAS) of low back pain (time frame: Change from baseline VAS at week 6). 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 30 Aug 2021.