A Comparative Study on Relieving Postpartum Lumbago with Fire-dragon Cupping Therapy and Acupuncture

Abstract: Objective To compare the effects of fire dragon pot therapy and acupuncture on low back pain, lumbar function, self-efficacy and postpartum depression in patients with postpartum low back pain. Methods From April 2024 to September 2024, 84 postpartum patients with low back pain who met the standard of sodium discharge in Hangzhou area were recruited and divided into acupuncture group (routine acupuncture + core stability training (42 cases) and Huolongcan group (42 cases) according to random number table method. Fire dragon pot + core stability training (42 cases), the two groups each intervention 30 min, once every other day, intervention 3 times. Before and after the intervention, the visual Analogue Scale (VAS) was used to evaluate the degree of low back pain, the Oswestry Disability Index (ODI) was used to evaluate the lumbar function, the pain Self-efficacy questionnaire (PSEQ) was used to evaluate the patients' confidence in effectively coping with pain, and the Edinburgh Postpartum Depression Scale (EPDS) was used to evaluate the postpartum depression. The changes of each index before and after intervention were observed.

Study Overview

• Status: Completed
• Conditions: Acupuncture; Postpartum Low Back Pain; Core Stability Training; Huolong Tank
• Intervention / Treatment: Combination product: Acupuncture combined with core stability training; Combination product: Dragon Tank joint core stability training

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Hangzhou Hospital Of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• (1) Postpartum 42 days to 1 year; (2) Visual analogue scale (VAS)[7]≥4 points; (3) Have basic reading comprehension ability, be able to fill out questionnaires independently, cooperate with investigation and treatment; (4) Sign informed consent voluntarily.

Exclusion Criteria:

• (1) Tumor, fracture, tuberculosis, bleeding tendency or serious organic disease; (2)Immune system diseases such as ankylosing spondylitis; (3) severe osteoporosis; (4) Patients with Yin deficiency and fire flourishing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupuncture group; Acupuncture and moxibustion group combined with core stability training.	Combination product: Acupuncture combined with core stability training; All patients were given routine health education guidance and core stability training. Acupuncture group combined with core stability training
Experimental: Huolong Tank Group; Huolong Tank group adopts Huolongcan combined core stability training	Combination product: Dragon Tank joint core stability training; All patients were given routine health education guidance and core stability training. Huolong Tank group adopts Huolongcan combined core stability training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain score	up to 24 weeks
Lumbar function score	up to 24 weeks
Self-efficacy score	up to 24 weeks
Postpartum depression score	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age		baseline, pre-intervention
course of disease	Refers to the total time of disease occurrence, recorded by month.	baseline, pre-intervention
production mode	It refers to the method that pregnant women choose to give birth, which can be divided into normal birth, caesarean section, and one birth along two births.	baseline, pre-intervention
parity	It refers to how many times a pregnant woman has been pregnant, including one, two, and three.	baseline, pre-intervention
Child feeding pattern	Refers to the pregnant women choose to feed the child, including pure breast milk, pure milk powder, breast milk powder mixed feeding	baseline, pre-intervention
The youngest age		baseline, pre-intervention
body mass index		baseline, pre-intervention

Collaborators and Investigators

• Sponsor: Qiaohui Ye

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2023KLL067

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
• product manufactured in and exported from the U.S.: No