Postpartum Low Back PainNCT06897891
A Comparative Study on Relieving Postpartum Lumbago with Fire-dragon Cupping Therapy and Acupuncture
A study testing Acupuncture combined with core stability training and Dragon Tank joint core stability training in people with Postpartum Low Back Pain and Acupuncture, run by Qiaohui Ye at 1 site in China.
Trial summary
Abstract: Objective To compare the effects of fire dragon pot therapy and acupuncture on low back pain, lumbar function, self-efficacy and postpartum depression in patients with postpartum low back pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postpartum Low Back Pain, Acupuncture, Core Stability Training
- What is being tested?
- Acupuncture combined with core stability training and Dragon Tank joint core stability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) Postpartum 42 days to 1 year; (2) Visual analogue scale (VAS)[7]≥4 points; (3) Have basic reading comprehension ability, be able to fill out questionnaires independently, cooperate with investigation and treatment; (4) Sign informed consent voluntarily.
Who cannot join
- (1) Tumor, fracture, tuberculosis, bleeding tendency or serious organic disease; (2)Immune system diseases such as ankylosing spondylitis; (3) severe osteoporosis; (4) Patients with Yin deficiency and fire flourishing
Trial locations and contacts
1 site in 1 country.
About this study
Abstract: Objective To compare the effects of fire dragon pot therapy and acupuncture on low back pain, lumbar function, self-efficacy and postpartum depression in patients with postpartum low back pain. Methods From April 2024 to September 2024, 84 postpartum patients with low back pain who met the standard of sodium discharge in Hangzhou area were recruited and divided into acupuncture group (routine acupuncture + core stability training (42 cases) and Huolongcan group (42 cases) according to random number table method. Fire dragon pot + core stability training (42 cases), the two groups each intervention 30 min, once every other day, intervention 3 times. Before and after the intervention, the visual Analogue Scale (VAS) was used to evaluate the degree of low back pain, the Oswestry Disability Index (ODI) was used to evaluate the lumbar function, the pain Self-efficacy questionnaire (PSEQ) was used to evaluate the patients' confidence in effectively coping with pain, and the Edinburgh Postpartum Depression Scale (EPDS) was used to evaluate the postpartum depression. The changes of each index before and after intervention were observed.
- Being tested
- Acupuncture combined with core stability training, Dragon Tank joint core stability training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture combined with core stability trainingCombination product
All patients were given routine health education guidance and core stability training. Acupuncture group combined with core stability training
Dragon Tank joint core stability trainingCombination product
All patients were given routine health education guidance and core stability training. Huolong Tank group adopts Huolongcan combined core stability training
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Active comparator | Acupuncture and moxibustion group combined with core stability training. Receives: Combination Product: Acupuncture combined with core stability training |
| Huolong Tank Group | Experimental | Huolong Tank group adopts Huolongcan combined core stability training Receives: Combination Product: Dragon Tank joint core stability training |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Measured: up to 24 weeks
Lumbar function score
Measured: up to 24 weeks
Self-efficacy score
Measured: up to 24 weeks
Postpartum depression score
Measured: up to 24 weeks
Secondary outcomes (7)
age
Measured: baseline, pre-intervention
course of disease
Refers to the total time of disease occurrence, recorded by month.
Measured: baseline, pre-intervention
production mode
It refers to the method that pregnant women choose to give birth, which can be divided into normal birth, caesarean section, and one birth along two births.
Measured: baseline, pre-intervention
parity
It refers to how many times a pregnant woman has been pregnant, including one, two, and three.
Measured: baseline, pre-intervention
Child feeding pattern
Refers to the pregnant women choose to feed the child, including pure breast milk, pure milk powder, breast milk powder mixed feeding
Measured: baseline, pre-intervention
The youngest age
Measured: baseline, pre-intervention
body mass index
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qiaohui Ye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiaohui Ye, Hangzhou Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897891
- Sponsor's protocol ID
- 2023KLL067
- Status last verified
- Sep 2024
- First submitted
- 17 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Relieving Postpartum Lumbago with Fire-dragon Cupping Therapy and Acupuncture
- ClinicalTrials.gov ID
- NCT06897891
- Acronym / sponsor ID
- 2023KLL067
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Qiaohui YeUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 27 Mar 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.
Abstract: Objective To compare the effects of fire dragon pot therapy and acupuncture on low back pain, lumbar function, self-efficacy and postpartum depression in patients with postpartum low back pain. Methods From April 2024 to September 2024, 84 postpartum patients with low back pain who met the standard of sodium discharge in Hangzhou area were recruited and divided into acupuncture group (routine acupuncture + core stability training (42 cases) and Huolongcan group (42 cases) according to random number table method. Fire dragon pot + core stability training (42 cases), the two groups each intervention 30 min, once every other day, intervention 3 times. Before and after the intervention, the visual Analogue Scale (VAS) was used to evaluate the degree of low back pain, the Oswestry Disability Index (ODI) was used to evaluate the lumbar function, the pain Self-efficacy questionnaire (PSEQ) was used to evaluate the patients' confidence in effectively coping with pain, and the Edinburgh Postpartum Depression Scale (EPDS) was used to evaluate the postpartum depression. The changes of each index before and after intervention were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Active comparator | Combination Product: Acupuncture combined with core stability trainingAcupuncture and moxibustion group combined with core stability training. |
| Huolong Tank Group | Experimental | Combination Product: Dragon Tank joint core stability trainingHuolong Tank group adopts Huolongcan combined core stability training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Postpartum 42 days to 1 year; (2) Visual analogue scale (VAS)[7]≥4 points; (3) Have basic reading comprehension ability, be able to fill out questionnaires independently, cooperate with investigation and treatment; (4) Sign informed consent voluntarily.
Key exclusion criteria (1 listed)
- (1) Tumor, fracture, tuberculosis, bleeding tendency or serious organic disease; (2)Immune system diseases such as ankylosing spondylitis; (3) severe osteoporosis; (4) Patients with Yin deficiency and fire flourishing
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 |
|---|---|---|
| Acupuncture combined with core stability trainingAll patients were given routine health education guidance and core stability training. Acupuncture group combined with core stability training | Combination product | Acupuncture group |
| Dragon Tank joint core stability trainingAll patients were given routine health education guidance and core stability training. Huolong Tank group adopts Huolongcan combined core stability training | Combination product | Huolong Tank Group |
Primary outcome
pain score
Time frame: up to 24 weeks
Lumbar function score
Time frame: up to 24 weeks
Self-efficacy score
Time frame: up to 24 weeks
Postpartum depression score
Time frame: up to 24 weeks
7 secondary outcomes
age
Time frame: baseline, pre-intervention
course of disease
Time frame: baseline, pre-intervention
production mode
Time frame: baseline, pre-intervention
parity
Time frame: baseline, pre-intervention
Child feeding pattern
Time frame: baseline, pre-intervention
The youngest age
Time frame: baseline, pre-intervention
body mass index
Time frame: baseline, pre-intervention
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 27 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture combined with core stability training and Dragon Tank joint core stability training in people with Postpartum Low Back Pain and Acupuncture, run by Qiaohui Ye at 1 site in China.
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 1 inclusion and 1 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 27 Mar 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 China. 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?
pain score (time frame: up to 24 weeks). The study lists 4 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 27 Mar 2025.