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.

Study Overview

• Status: Recruiting
• Conditions: Diastasis Recti Abdominis
• Intervention / Treatment: Other: Stone needle therapy follows the Belt channel

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zuiqin Zhang; Phone Number: +8618725365145; Email: 2357656738@qq.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650021
      • Recruiting
      • Yunnan Provincial Hospital of Traditional Chinese Medicine
      • Contact: Weibo Wen; Phone Number: 0871-63631649; Email: yntcmhopxc@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Patients who are >42d postpartum and have cleaned up their discharge;
3. Women who are 42day-3 mouths after normal delivery;
4. Postpartum women who have not received any other treatment before treatment in our hospital;

Exclusion Criteria:

1. 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;
2. Those with contraindications to stone therapy;
3. Those with contraindications to bioelectric stimulation therapy.
4. Combined with puerperal infection and gastrointestinal adhesion;
5. Patients with postpartum back pain due to other reasons such as lumbar disc herniation or kidney stones;
6. Patients who cannot tolerate the program;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stone needle therapy follows the Belt channel; 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.	Other: Stone needle therapy follows the Belt channel; 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.
Other: control group; 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.	Other: Stone needle therapy follows the Belt channel; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inter-recti distance	Bilateral rectus abdominis distance	pre-intervention and after three stone needle therapies interventions
Abdominal circumference	Horizontal circumference of the abdomen via the iliac crest point.	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.	pre-intervention and after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	pre-intervention and measured immediately after completion of all treatments

Collaborators and Investigators

• Sponsor: Yunnan University of Chinese Medicine
• Investigators: Principal Investigator: Jun Ma, The First Affiliated Hospital of Yunnan University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: postpartum diastasis rectus abdominis Belt channel; stone needle therapy; Belt channel; rehabilitative nursing
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Diastasis, Muscle
• Other Study ID Numbers: XW2023-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No