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

NCT06552143 | Recruiting

• 1 other identifier: XW2023-025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diastasis Recti Abdominis

Keywords

postpartum diastasis rectus abdominis Belt channel; stone needle therapy; Belt channel; rehabilitative nursing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Low back pain Visual Analogue Scale

  pre-intervention and after intervention

• Oswestry Disability Index

  pre-intervention and measured immediately after completion of all treatments

• Self-Rating Anxiety Scale

  pre-intervention and measured immediately after completion of all treatments

• Edinburgh postnatal depression scale

  pre-intervention and measured immediately after completion of all treatments

• THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE

  pre-intervention and measured immediately after completion of all treatments

Study Arms (2)

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.

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.

Other: Stone needle therapy follows the Belt channel

Interventions

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.

Stone needle therapy follows the Belt channel; control group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yunnan University of Chinese Medicine: lead

Study Sites (1)

YunNan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, 650021, China

RECRUITING

Study Officials

• Jun Ma

  The First Affiliated Hospital of Yunnan University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zuiqin Zhang

CONTACT

+8618725365145; 2357656738@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor did not know whether the patient being measured belonged to the control or intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Nursing Students

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 13, 2024
• Study Start: September 1, 2023
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)