Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diastasis Recti Abdominis
Keywords: postpartum diastasis rectus abdominis Belt channel
stone needle therapy
Belt channel
rehabilitative nursing
Lead sponsor: Yunnan University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: inter-recti distance
timeFrame: pre-intervention and after three stone needle therapies interventions
measure: Abdominal circumference
timeFrame: pre-intervention and after three stone needle therapies interventions
measure: Body Image Satisfaction
timeFrame: pre-intervention and after intervention
Secondary outcomes:
measure: Low back pain Visual Analogue Scale
timeFrame: pre-intervention and after intervention
measure: Oswestry Disability Index
timeFrame: pre-intervention and measured immediately after completion of all treatments
measure: Self-Rating Anxiety Scale
timeFrame: pre-intervention and measured immediately after completion of all treatments
measure: Edinburgh postnatal depression scale
timeFrame: pre-intervention and measured immediately after completion of all treatments
measure: THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE
timeFrame: pre-intervention and measured immediately after completion of all treatments
Other outcomes:
Locations:
city: Kunming
country: China
facility: YunNan Provincial Hospital of Traditional Chinese Medicine
state: Yunnan
Study officials:
affiliation: The First Affiliated Hospital of Yunnan University of Chinese Medicine
name: Jun Ma
role: PRINCIPAL_INVESTIGATOR
References: