Diastasis Recti AbdominisNCT06552143
An Applied Study on the Use of Stone Needles Therapy to Assist the Rehabilitation of Maternal Diastasis Rectus Abdominis Based on the Theory of Belt Channel
A study testing Stone needle therapy follows the Belt channel in people with Diastasis Recti Abdominis, run by Yunnan University of Chinese Medicine at 1 site in China.
Trial summary
This clinical trial aims to find out whether stone needles therapy can effectively assist in the treatment of maternal diastasis rectus abdominis (DRA) based on the Belt channel theory, it will also validate whether the Ben-Tovim Walker body attitude questionnaire (BAQ) can be used as a tool to measure body image… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Diastasis Recti Abdominis
- What is being tested?
- Stone needle therapy follows the Belt channel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 20 Sep 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients who meet the diagnostic criteria of postpartum rectus abdominis muscle separation, and the distance of rectus abdominis muscle separation is ≥3.0cm with postpartum low back pain.
- Patients who are >42d postpartum and have cleaned up their discharge;
- Women who are 42day-3 mouths after normal delivery;
- Postpartum women who have not received any other treatment before treatment in our hospital;
Who cannot join
- With severe parenchymal organ diseases such as renal, cardiac, or hepatic diseases or due to comorbid cognitive impairment, Alzheimer's disease or psychological or psychiatric diseases can not complete the cooperation, etc;
- Those with contraindications to stone therapy;
- Those with contraindications to bioelectric stimulation therapy.
- Combined with puerperal infection and gastrointestinal adhesion;
- Patients with postpartum back pain due to other reasons such as lumbar disc herniation or kidney stones;
- Patients who cannot tolerate the program;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
YunNan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, 650021
Weibo Wen, 0871-63631649, yntcmhopxc@126.com
About this study
This clinical trial aims to find out whether stone needles therapy can effectively assist in the treatment of maternal diastasis rectus abdominis (DRA) based on the Belt channel theory, it will also validate whether the Ben-Tovim Walker body attitude questionnaire (BAQ) can be used as a tool to measure body image satisfaction in Chinese patients with postpartum DRA. The main questions it aims to answer are: Can stone needles therapy promote the recovery of maternal DRA? Whether the Chinese version of the Body attitude questionnaire (BAQ-C) can be used as a body image satisfaction measurement tool for patients with postpartum DRA. The researchers will add stone needles therapy to neuromuscular electrical stimulation (NMES) and massage therapy to see if stone needles therapy can promote the recovery of postpartum DRA.
Read the detailed description
Participants will: Receive NMES combined with massage therapy or the addition of stone needles therapy on a sub-basis every day for 10 days.
Abdominal circumference, inner rectus distance will be measured and recorded after each treatment Body imagery satisfaction, low back pain and dysfunction scores, anxiety, depression scores, and quality of life scores will be measured after all treatments are completed.
- Conditions
- Diastasis Recti Abdominis
- Being tested
- Stone needle therapy follows the Belt channel
- Keywords
- postpartum diastasis rectus abdominis Belt channel, stone needle therapy, Belt channel, rehabilitative nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stone needle therapy follows the Belt channelOther
Stone needle therapy follows the Belt channel involves the use of stones by the intervener to follow the path of the Belt channel by pushing and rubbing the abdomen of patients with postpartum diastasis rectus abdominis.
| Study group | Role | What they receive |
|---|---|---|
| Stone needle therapy follows the Belt channel | Other | generic name: Stone needle therapy frequency: Neuromuscular Electrical Stimulation (NMES) for a total of 10 sessions, with the addition of massage therapy after the 3rd, 6th, and 9th NMES sessions, and stone needle therapy after each massage session for a total of 3 sessions.
dosage: Thirty minutes at a time, three times in total. Receives: Other: Stone needle therapy follows the Belt channel |
| control group | Other | generic name: Neuromuscular Electrical Stimulation combined with massage therapy frequency: Neuromuscular Electrical Stimulation (NMES) for a total of 10 sessions, with the addition of massage therapy after the 3rd, 6th, and 9th NMES sessions.
dosage: Thirty minutes at a time, three times in total. Receives: Other: Stone needle therapy follows the Belt channel |
What is being measured
The primary outcome is the main question the study is designed to answer.
inter-recti distance
Bilateral rectus abdominis distance
Measured: pre-intervention and after three stone needle therapies interventions
Abdominal circumference
Horizontal circumference of the abdomen via the iliac crest point.
Measured: pre-intervention and after three stone needle therapies interventions
Body Image Satisfaction
Body image satisfaction refers to how a person perceives, thinks, or feels about his or her body.
Measured: pre-intervention and after intervention
Secondary outcomes (5)
Low back pain Visual Analogue Scale
A 10 cm horizontal line is drawn on top of the paper, and the visual analogue scale (VAS) is used for the horizontal line. The line is 0mm at one end, which means 'no pain at all'; 10mm at the other end, which means 'extreme pain'; the pain level increases from 0mm to 10mm, with higher scores representing more intense pain.
Measured: pre-intervention and after intervention
Oswestry Disability Index
The Oswestry Disability Index (ODI) is a widely used measure for assessing the function a limitations and disability associated with lower back pain. This index provides a standardized way to evaluate the impact of back pain on a person's daily activities and overall quality of life.
Measured: pre-intervention and measured immediately after completion of all treatments
Self-Rating Anxiety Scale
It is a commonly used psychometric tool developed by the American psychologist Zung, and is a self-report scale used to assess an individual's level of anxiety.
Measured: pre-intervention and measured immediately after completion of all treatments
Edinburgh postnatal depression scale
A standardized questionnaire to detect symptoms of depression in postnatal women.
Measured: pre-intervention and measured immediately after completion of all treatments
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE
It is a tool used to assess people's quality of life, which helps to collect and analyse information about the individual's state of health, psychological functioning, social competence, etc.
Measured: pre-intervention and measured immediately after completion of all treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Sep 2023
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis Recti AbdominisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The patients were divided into control and intervention groups according to the time of their visit to the clinic. The patients who met the inclusion and exclusion criteria of the study from February to May 2023 were the control group and the patients who met the inclusion and exclusion criteria of the study from June to September 2023 were the intervention group. The number of patients in each group was 60.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuoqin Zhang, Yunnan University of Chinese Medicine
- Investigators
- Jun Ma, Principal investigator, The First Affiliated Hospital of Yunnan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552143
- Sponsor's protocol ID
- XW2023-025
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Applied Study on the Use of Stone Needles Therapy to Assist the Rehabilitation of Maternal Diastasis Rectus Abdominis Based on the Theory of Belt Channel
- ClinicalTrials.gov ID
- NCT06552143
- Acronym / sponsor ID
- XW2023-025
- Conditions
- Diastasis Recti Abdominis
- Keywords
- postpartum diastasis rectus abdominis Belt channel, stone needle therapy, Belt channel, rehabilitative nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yunnan University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 13 Aug 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 clinical trial aims to find out whether stone needles therapy can effectively assist in the treatment of maternal diastasis rectus abdominis (DRA) based on the Belt channel theory, it will also validate whether the Ben-Tovim Walker body attitude questionnaire (BAQ) can be used as a tool to measure body image satisfaction in Chinese patients with postpartum DRA. The main questions it aims to answer are: Can stone needles therapy promote the recovery of maternal DRA? Whether the Chinese version of the Body attitude questionnaire (BAQ-C) can be used as a body image satisfaction measurement tool for patients with postpartum DRA. The researchers will add stone needles therapy to neuromuscular electrical stimulation (NMES) and massage therapy to see if stone needles therapy can promote the recovery of postpartum DRA.
Detailed description
Participants will: Receive NMES combined with massage therapy or the addition of stone needles therapy on a sub-basis every day for 10 days.
Abdominal circumference, inner rectus distance will be measured and recorded after each treatment Body imagery satisfaction, low back pain and dysfunction scores, anxiety, depression scores, and quality of life scores will be measured after all treatments are completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients were divided into control and intervention groups according to the time of their visit to the clinic. The patients who met the inclusion and exclusion criteria of the study from February to May 2023 were the control group and the patients who met the inclusion and exclusion criteria of the study from June to September 2023 were the intervention group. The number of patients in each group was 60.
| Arm | Type | Receives |
|---|---|---|
| Stone needle therapy follows the Belt channel | Other | Other: Stone needle therapy follows the Belt channelgeneric name: Stone needle therapy frequency: Neuromuscular Electrical Stimulation (NMES) for a total of 10 sessions, with the addition of massage therapy after the 3rd, 6th, and 9th NMES sessions, and stone needle therapy after each massage session for a total of 3 sessions. dosage: Thirty minutes at a time, three times in total. |
| control group | Other | Other: Stone needle therapy follows the Belt channelgeneric name: Neuromuscular Electrical Stimulation combined with massage therapy frequency: Neuromuscular Electrical Stimulation (NMES) for a total of 10 sessions, with the addition of massage therapy after the 3rd, 6th, and 9th NMES sessions. dosage: Thirty minutes at a time, three times in total. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patients who meet the diagnostic criteria of postpartum rectus abdominis muscle separation, and the distance of rectus abdominis muscle separation is ≥3.0cm with postpartum low back pain.
- Patients who are >42d postpartum and have cleaned up their discharge;
- Women who are 42day-3 mouths after normal delivery;
- Postpartum women who have not received any other treatment before treatment in our hospital;
Key exclusion criteria (6 listed)
- With severe parenchymal organ diseases such as renal, cardiac, or hepatic diseases or due to comorbid cognitive impairment, Alzheimer's disease or psychological or psychiatric diseases can not complete the cooperation, etc;
- Those with contraindications to stone therapy;
- Those with contraindications to bioelectric stimulation therapy.
- Combined with puerperal infection and gastrointestinal adhesion;
- Patients with postpartum back pain due to other reasons such as lumbar disc herniation or kidney stones;
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 |
|---|---|---|
| Stone needle therapy follows the Belt channelStone needle therapy follows the Belt channel involves the use of stones by the intervener to follow the path of the Belt channel by pushing and rubbing the abdomen of patients with postpartum diastasis rectus abdominis. | Other | Stone needle therapy follows the Belt channel, control group |
Primary outcome
inter-recti distance
Time frame: pre-intervention and after three stone needle therapies interventions
Bilateral rectus abdominis distance
Abdominal circumference
Time frame: pre-intervention and after three stone needle therapies interventions
Horizontal circumference of the abdomen via the iliac crest point.
Body Image Satisfaction
Time frame: pre-intervention and after intervention
Body image satisfaction refers to how a person perceives, thinks, or feels about his or her body.
5 secondary outcomes
Low back pain Visual Analogue Scale
Time frame: pre-intervention and after intervention
Oswestry Disability Index
Time frame: pre-intervention and measured immediately after completion of all treatments
Self-Rating Anxiety Scale
Time frame: pre-intervention and measured immediately after completion of all treatments
Edinburgh postnatal depression scale
Time frame: pre-intervention and measured immediately after completion of all treatments
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE
Time frame: pre-intervention and measured immediately after completion of all treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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.
Jun Ma principal investigator
The First Affiliated Hospital of Yunnan University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stone needle therapy follows the Belt channel in people with Diastasis Recti Abdominis, run by Yunnan University of Chinese Medicine 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zuiqin Zhang (+8618725365145, 2357656738@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inter-recti distance (time frame: pre-intervention and after three stone needle therapies interventions). The study lists 3 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 13 Aug 2024.