Pregnancy-related Low Back and Pelvic PainNCT07153653
Managing Pregnancy Pain With Baduanjin Exercise
A study testing Prenatal Baduanjin Exercise Program in people with Pregnancy-related Low Back and Pelvic Pain and Pregnancy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a randomized controlled trial studying whether a 12-week Baduanjin exercise program (a traditional Chinese mind-body exercise) can reduce low back pain and improve quality of life in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy-related Low Back and Pelvic Pain, Pregnancy
- What is being tested?
- Prenatal Baduanjin Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2025to 30 Jun 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single pregnancy (carrying one fetus).
- Gestational age: 14-20 weeks at enrollment.
- No contraindications to exercise during pregnancy (as determined by medical evaluation).
Who cannot join
- Adverse pregnancy symptoms:
- Dizziness, blurred vision, vaginal bleeding, or other high-risk signs.
- Pre-existing medical conditions: Orthopedic, cardiovascular, or psychiatric diseases; cognitive impairment.
- Pregnancy complications: Preterm labor, placenta previa.
- Inability to attend regular prenatal check-ups.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College
Beijing, Beijing Municipality, 100730
Liangkun Ma, +8613021961166, maliangkun@pumch.cn
About this study
Official title: Effect of Baduanjin Exercise Intervention on Pregnancy-Related Pain and Quality of Life: A Randomized Controlled Trial
This is a randomized controlled trial studying whether a 12-week Baduanjin exercise program (a traditional Chinese mind-body exercise) can reduce low back pain and improve quality of life in pregnant women.
- Being tested
- Prenatal Baduanjin Exercise Program
- Keywords
- pregnancy-related Low back and pelvic pain, pregnancy, low back pain, pelvic girdle pain
- Medical subject headings
- Pelvic Pain, Low Back Pain, Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Baduanjin Exercise ProgramBehavioural
A structured 12-week program featuring Baduanjin, a traditional Chinese mind-body exercise involving gentle, flowing movements. Participants receive 24 online instructional sessions (approximately 2 s
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin Group | Experimental | Prenatal Baduanjin Exercise Program Receives: Behavioral: Prenatal Baduanjin Exercise Program |
| Standard Clinic Prenatal Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Back Pain Severity
Measured using Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst imaginable pain. Assesses self-reported low back/pelvic girdle pain intensity.
Measured: Baseline, 6 weeks, post-intervention (12 weeks)
Secondary outcomes (4)
Back Disability
Functional limitations measured using: Chinese Oswestry Disability Index. Higher scores indicate greater disability.
Measured: Baseline, 6 weeks, post-intervention (12 weeks)
Pelvic Disability
Functional limitations measured using: Pelvic Girdle Questionnaire. Higher scores indicate greater disability.
Measured: Baseline, 6 weeks, post-intervention (12 weeks)
Urinary Incontinence
Measured using: ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form)). Higher scores indicate worse symptoms/impact.
Measured: Baseline, 6 weeks, post-intervention (12 weeks)
Urinary Incontinence Severity
Measured using: IIQ-7 (Incontinence Impact Questionnaire-7). Higher scores indicate greater disability.
Measured: Baseline, 6 weeks, post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start13 Mar 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy-related Low Back and Pelvic PainStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, Study chair, Chinese Academy of Medical Science & Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153653
- Sponsor's protocol ID
- K5090
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2025
- Last updated
- 4 Sep 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baduanjin Exercise Intervention on Pregnancy-Related Pain and Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07153653
- Acronym / sponsor ID
- K5090
- Keywords
- pregnancy-related Low back and pelvic pain, pregnancy, low back pain, pelvic girdle pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Sep 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 is a randomized controlled trial studying whether a 12-week Baduanjin exercise program (a traditional Chinese mind-body exercise) can reduce low back pain and improve quality of life in pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin Group | Experimental | Behavioral: Prenatal Baduanjin Exercise ProgramPrenatal Baduanjin Exercise Program |
| Standard Clinic Prenatal Care | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Single pregnancy (carrying one fetus).
- Gestational age: 14-20 weeks at enrollment.
- No contraindications to exercise during pregnancy (as determined by medical evaluation).
Key exclusion criteria (5 listed)
- Adverse pregnancy symptoms:
- Dizziness, blurred vision, vaginal bleeding, or other high-risk signs.
- Pre-existing medical conditions: Orthopedic, cardiovascular, or psychiatric diseases; cognitive impairment.
- Pregnancy complications: Preterm labor, placenta previa.
- Inability to attend regular prenatal check-ups.
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 |
|---|---|---|
| Prenatal Baduanjin Exercise ProgramA structured 12-week program featuring Baduanjin, a traditional Chinese mind-body exercise involving gentle, flowing movements. Participants receive 24 online instructional sessions (approximately 2 s | Behavioural | Baduanjin Group |
Primary outcome
Low Back Pain Severity
Time frame: Baseline, 6 weeks, post-intervention (12 weeks)
Measured using Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst imaginable pain. Assesses self-reported low back/pelvic girdle pain intensity.
4 secondary outcomes
Back Disability
Time frame: Baseline, 6 weeks, post-intervention (12 weeks)
Pelvic Disability
Time frame: Baseline, 6 weeks, post-intervention (12 weeks)
Urinary Incontinence
Time frame: Baseline, 6 weeks, post-intervention (12 weeks)
Urinary Incontinence Severity
Time frame: Baseline, 6 weeks, post-intervention (12 weeks)
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 4 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Pregnancy-related Low Back and Pelvic Pain
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The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain
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Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain.
Low Back Pain, Lumbopelvic Pain
RecruitingObservational study
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Chronic Pain, Acute Pain
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.
Liangkun Ma study chair
Chinese Academy of Medical Science & Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Baduanjin Exercise Program in people with Pregnancy-related Low Back and Pelvic Pain and Pregnancy, run by Peking Union Medical College Hospital 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Sep 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?
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?
Contact Liangkun Ma (+8613021961166, maliangkun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Back Pain Severity (time frame: Baseline, 6 weeks, post-intervention (12 weeks)). 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 4 Sep 2025.