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

NCT06897891 | Completed

• 1 other identifier: 2023KLL067
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Low Back Pain; Acupuncture; Core Stability Training; Huolong Tank

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• age

  baseline, pre-intervention

• course of disease

  baseline, pre-intervention

• production mode

  baseline, pre-intervention

• parity

  baseline, pre-intervention

• Child feeding pattern

  baseline, pre-intervention

Study Arms (2)

Acupuncture group

ACTIVE COMPARATOR

Acupuncture and moxibustion group combined with core stability training.

Combination Product: Acupuncture combined with core stability training

Huolong Tank Group

EXPERIMENTAL

Huolong Tank group adopts Huolongcan combined core stability training

Combination Product: Dragon Tank joint core stability training

Interventions

Acupuncture combined with core stability training COMBINATION_PRODUCT

All patients were given routine health education guidance and core stability training. Acupuncture group combined with core stability training

Acupuncture group

Dragon Tank joint core stability training COMBINATION_PRODUCT

All patients were given routine health education guidance and core stability training. Huolong Tank group adopts Huolongcan combined core stability training

Huolong Tank Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Qiaohui Ye: lead

Study Sites (1)

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hangzhou Hospital of Traditional Chinese Medicine

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 27, 2025
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 27, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)