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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Deep Needling Protrusion of Lumbar Intervertebral Disc the Five Acupoints

NCT02824887

Protrusion of Lumbar Intervertebral Disc

UNKNOWN

Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain.

NCT06286969

Lumbar Muscle Strain

NOT_YET_RECRUITING NA

Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients

NCT06133205

Acupuncture

COMPLETED NA

Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine

NCT03236753

Lumbar Disc Herniation

COMPLETED NA

A Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity

NCT03325179

Weight Loss Simple Obesity

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diastasis Recti Abdominis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor did not know whether the patient being measured belonged to the control or intervention group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Stone needle therapy follows the Belt channel

Intervention Type 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.

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.

Group Type OTHER

Stone needle therapy follows the Belt channel

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No