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NCT Number: NCT06552143

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

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.

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Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

YunNan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, 650021, China

Location status: Recruiting

Location contact

Weibo Wen

CONTACT

[email protected]

0871-63631649

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

Stone needle therapy follows the Belt channel

Other

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.

Primary outcomes

  1. inter-recti distance

    Time frame: pre-intervention and after three stone needle therapies interventions

    Bilateral rectus abdominis distance

  2. Abdominal circumference

    Time frame: pre-intervention and after three stone needle therapies interventions

    Horizontal circumference of the abdomen via the iliac crest point.

  3. 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.

Secondary outcomes

  1. Low back pain Visual Analogue Scale

    Time frame: pre-intervention and after intervention

    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.

  2. Oswestry Disability Index

    Time frame: pre-intervention and measured immediately after completion of all treatments

    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.

  3. Self-Rating Anxiety Scale

    Time frame: pre-intervention and measured immediately after completion of all treatments

    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.

  4. Edinburgh postnatal depression scale

    Time frame: pre-intervention and measured immediately after completion of all treatments

    A standardized questionnaire to detect symptoms of depression in postnatal women.

  5. THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE

    Time frame: pre-intervention and measured immediately after completion of all treatments

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zuiqin Zhang

CONTACT

[email protected]

+8618725365145

Sponsors and collaborators

Lead sponsor

Yunnan University of Chinese Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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