Clinical Effects of Moxibustion Combined With Tailored Baduanjin Exercise Programs on Early Postoperative Rehabilitation in Lumbar Disc Herniation Patients Undergoing Minimally Invasive Surgery

NCT ID: NCT07015658

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-30

Brief Summary

This study is a single-center randomized controlled trial, aiming to explore the effect of moxibustion combined with the modified Baduanjin exercise regimen on the early rehabilitation of patients with lumbar disc herniation (LDH) after minimally invasive surgery. A total of 120 patients were included in the study and randomly divided into the control group (conventional treatment and rehabilitation care), the Baduanjin group (conventional treatment + modified Baduanjin), and the combined intervention group (conventional treatment + Baduanjin + moxibustion). By comparing the visual pain scores (VAS), lumbar function scores (JOA), lumbar range of motion, and anxiety scale (HAMA) changes at 1 day, 1 month, and 3 months after surgery, the study evaluated the improvement effect of the integrated traditional Chinese medicine and Western medicine rehabilitation plan on postoperative pain relief, functional recovery, and psychological state. The study innovatively integrates the advantages of traditional Chinese medicine moxibustion for warming and promoting meridians and the low-intensity exercise of the modified Baduanjin, optimizes the difficulty of traditional rehabilitation training, and provides evidence-based basis for improving patient compliance and standardizing postoperative rehabilitation programs.

Conditions

Lumbar Disc Herniations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

1\. Routine nursing measures: Postoperatively, routine basic treatments such as preventing infection, anti-inflammatory and analgesic therapy, nourishing the nerves, eliminating edema, and suppressing acid and protecting the stomach are provided. After discharge, patients are instructed to take anti-inflammatory and analgesic drugs and nourishing nerve drugs as prescribed. Systematic nursing interventions are carried out after the operation, including psychological intervention and health education; avoid prolonged sitting, prolonged standing, heavy lifting and physical labor. Adopt the correct standing and walking postures, and use a waist brace for protected bed mobility for one month. After discharge, instruct patients to visit the clinic for regular follow-ups and consult as needed.

Group Type: ACTIVE_COMPARATOR

Conventional intervention

Intervention Type: PROCEDURE

Postoperative Rehabilitation Exercises: Week 1: Ankle Pump Exercises: Start after anesthesia. Slowly rotate/invert, dorsiflex/plantarflex ankles. Hold each position 10-15s. 30 min/set, 6 sets/day, until ambulation. Straight Leg Raising (SLR): Start Day 2, supine. Elevate leg \>30°. Progress from passive to active hold. Hold 5-10s/rep, 10-20 reps/set. 3 sets (morning/noon/night) daily for 15 days. Week 2: Supine hip/knee flexion exercises in bed. Hold each flexion 3-5s. 30-50 reps/set. 2 sets/day. Weeks 3-4: Start back muscle training (e.g., bridge/bird-dog poses). Months 1-3: Gradually increase back exercise frequency/difficulty. Perform flexion, extension, lateral flexion, and rotation wearing a lumbar brace. Intensity/reps based on tolerance.

Baduanjin Group

The Baduanjin protocol, based on China's 2003 General Administration of Sport standard, was modified by professional physiotherapists for targeted adaptations, with nurses receiving specialized training. Patients viewed step-by-step instructional clips upon admission alongside a full-length routine video. Standard postoperative rehabilitation was maintained during Weeks 1-2. At Week 3, patients demonstrating adequate wound healing and unimpaired static lumbar muscle contraction performed Baduanjin exercises wearing a lumbar brace, supervised by trained nurses for movement correction. The brace was discontinued after 8 weeks. Modified professional videos with background music were distributed via WeChat/official accounts twice daily (30min/session, 5 days/week) for 13 weeks (total ≥2000min). Duration/frequency adjustments were permitted based on individual recovery and physician recommendations post-intervention.

Group Type: EXPERIMENTAL

Baduanjin

Intervention Type: PROCEDURE

The Baduanjin protocol, based on China's 2003 General Administration of Sport standard, was modified by professional physiotherapists for targeted adaptations, with nurses receiving specialized training. Patients viewed step-by-step instructional clips upon admission alongside a full-length routine video. Standard postoperative rehabilitation was maintained during Weeks 1-2. At Week 3, patients demonstrating adequate wound healing and unimpaired static lumbar muscle contraction performed Baduanjin exercises wearing a lumbar brace, supervised by trained nurses for movement correction. The brace was discontinued after 8 weeks. Modified professional videos with background music were distributed via WeChat/official accounts twice daily (30min/session, 5 days/week) for 13 weeks (total ≥2000min). Duration/frequency adjustments were permitted based on individual recovery and physician recommendations post-intervention.

Conventional intervention

Intervention Type: PROCEDURE

Postoperative Rehabilitation Exercises: Week 1: Ankle Pump Exercises: Start after anesthesia. Slowly rotate/invert, dorsiflex/plantarflex ankles. Hold each position 10-15s. 30 min/set, 6 sets/day, until ambulation. Straight Leg Raising (SLR): Start Day 2, supine. Elevate leg \>30°. Progress from passive to active hold. Hold 5-10s/rep, 10-20 reps/set. 3 sets (morning/noon/night) daily for 15 days. Week 2: Supine hip/knee flexion exercises in bed. Hold each flexion 3-5s. 30-50 reps/set. 2 sets/day. Weeks 3-4: Start back muscle training (e.g., bridge/bird-dog poses). Months 1-3: Gradually increase back exercise frequency/difficulty. Perform flexion, extension, lateral flexion, and rotation wearing a lumbar brace. Intensity/reps based on tolerance.

Combined Intervention Group

Moxibustion was performed at acupoints including Yaoyangguan (GV3), Shenshu (BL23), Dachangshu (BL25, affected side), Chengfu (BL36), Mingmen (GV4), Weizhong (BL40, affected side), Taixi (KI3), Fuliu (KI7), Zhishi (BL52), Zusanli (ST36), and Ashi points. Using five-year-aged Qizhou mugwort, the patient's treatment areas were fully exposed in a comfortable position. The moxa stick was held 3-4 cm from the skin with intensity adjusted to patient tolerance to prevent burns. The circular moxibustion technique was applied for 3-5 minutes per acupoint until the skin exhibited erythema, perspiration, or mottling, or until the patient experienced warmth, distension, itchiness, or perceived moxa-heat propagation. Treatment commenced at postoperative Week 3 following evaluation of satisfactory wound healing, administered three times weekly for four consecutive weeks.

Group Type: EXPERIMENTAL

Baduanjin

Intervention Type: PROCEDURE

The Baduanjin protocol, based on China's 2003 General Administration of Sport standard, was modified by professional physiotherapists for targeted adaptations, with nurses receiving specialized training. Patients viewed step-by-step instructional clips upon admission alongside a full-length routine video. Standard postoperative rehabilitation was maintained during Weeks 1-2. At Week 3, patients demonstrating adequate wound healing and unimpaired static lumbar muscle contraction performed Baduanjin exercises wearing a lumbar brace, supervised by trained nurses for movement correction. The brace was discontinued after 8 weeks. Modified professional videos with background music were distributed via WeChat/official accounts twice daily (30min/session, 5 days/week) for 13 weeks (total ≥2000min). Duration/frequency adjustments were permitted based on individual recovery and physician recommendations post-intervention.

Moxibustion

Intervention Type: PROCEDURE

Moxibustion was performed at acupoints including Yaoyangguan (GV3), Shenshu (BL23), Dachangshu (BL25, affected side), Chengfu (BL36), Mingmen (GV4), Weizhong (BL40, affected side), Taixi (KI3), Fuliu (KI7), Zhishi (BL52), Zusanli (ST36), and Ashi points. Using five-year-aged Qizhou mugwort, the patient's treatment areas were fully exposed in a comfortable position. The moxa stick was held 3-4 cm from the skin with intensity adjusted to patient tolerance to prevent burns. The circular moxibustion technique was applied for 3-5 minutes per acupoint until the skin exhibited erythema, perspiration, or mottling, or until the patient experienced warmth, distension, itchiness, or perceived moxa-heat propagation. Treatment commenced at postoperative Week 3 following evaluation of satisfactory wound healing, administered three times weekly for four consecutive weeks.

Conventional intervention

Intervention Type: PROCEDURE

Postoperative Rehabilitation Exercises: Week 1: Ankle Pump Exercises: Start after anesthesia. Slowly rotate/invert, dorsiflex/plantarflex ankles. Hold each position 10-15s. 30 min/set, 6 sets/day, until ambulation. Straight Leg Raising (SLR): Start Day 2, supine. Elevate leg \>30°. Progress from passive to active hold. Hold 5-10s/rep, 10-20 reps/set. 3 sets (morning/noon/night) daily for 15 days. Week 2: Supine hip/knee flexion exercises in bed. Hold each flexion 3-5s. 30-50 reps/set. 2 sets/day. Weeks 3-4: Start back muscle training (e.g., bridge/bird-dog poses). Months 1-3: Gradually increase back exercise frequency/difficulty. Perform flexion, extension, lateral flexion, and rotation wearing a lumbar brace. Intensity/reps based on tolerance.

Interventions

Baduanjin

The Baduanjin protocol, based on China's 2003 General Administration of Sport standard, was modified by professional physiotherapists for targeted adaptations, with nurses receiving specialized training. Patients viewed step-by-step instructional clips upon admission alongside a full-length routine video. Standard postoperative rehabilitation was maintained during Weeks 1-2. At Week 3, patients demonstrating adequate wound healing and unimpaired static lumbar muscle contraction performed Baduanjin exercises wearing a lumbar brace, supervised by trained nurses for movement correction. The brace was discontinued after 8 weeks. Modified professional videos with background music were distributed via WeChat/official accounts twice daily (30min/session, 5 days/week) for 13 weeks (total ≥2000min). Duration/frequency adjustments were permitted based on individual recovery and physician recommendations post-intervention.

Intervention Type: PROCEDURE

Moxibustion

Moxibustion was performed at acupoints including Yaoyangguan (GV3), Shenshu (BL23), Dachangshu (BL25, affected side), Chengfu (BL36), Mingmen (GV4), Weizhong (BL40, affected side), Taixi (KI3), Fuliu (KI7), Zhishi (BL52), Zusanli (ST36), and Ashi points. Using five-year-aged Qizhou mugwort, the patient's treatment areas were fully exposed in a comfortable position. The moxa stick was held 3-4 cm from the skin with intensity adjusted to patient tolerance to prevent burns. The circular moxibustion technique was applied for 3-5 minutes per acupoint until the skin exhibited erythema, perspiration, or mottling, or until the patient experienced warmth, distension, itchiness, or perceived moxa-heat propagation. Treatment commenced at postoperative Week 3 following evaluation of satisfactory wound healing, administered three times weekly for four consecutive weeks.

Intervention Type: PROCEDURE

Conventional intervention

Postoperative Rehabilitation Exercises: Week 1: Ankle Pump Exercises: Start after anesthesia. Slowly rotate/invert, dorsiflex/plantarflex ankles. Hold each position 10-15s. 30 min/set, 6 sets/day, until ambulation. Straight Leg Raising (SLR): Start Day 2, supine. Elevate leg \>30°. Progress from passive to active hold. Hold 5-10s/rep, 10-20 reps/set. 3 sets (morning/noon/night) daily for 15 days. Week 2: Supine hip/knee flexion exercises in bed. Hold each flexion 3-5s. 30-50 reps/set. 2 sets/day. Weeks 3-4: Start back muscle training (e.g., bridge/bird-dog poses). Months 1-3: Gradually increase back exercise frequency/difficulty. Perform flexion, extension, lateral flexion, and rotation wearing a lumbar brace. Intensity/reps based on tolerance.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ① Refer to the diagnostic criteria for LDH in the "Diagnosis and Treatment Guidelines for Lumbar Intervertebral Disc Protrusion (2020 Edition)";

• Age > 18 years old; ③ Patients who have not responded to conservative treatment and have undergone minimally invasive surgery for lumbar intervertebral disc protrusion in our hospital, including percutaneous puncture interventional procedures (percutaneous intervertebral disc aspiration, percutaneous intervertebral disc laser ablation, percutaneous intervertebral disc ozone ablation, and radiofrequency nucleus removal and formation), micro-lumbar intervertebral disc resection, micro-endoscopic lumbar intervertebral disc resection, and percutaneous endoscopic lumbar intervertebral disc resection; ④ Participants who voluntarily participate in this study.

Exclusion Criteria

• ① Previous history of lumbar surgery;

• Those with severe spinal canal stenosis or other severe deformities;

• Patients with bleeding tendencies or hematological diseases; ④ Patients with mental disorders and cognitive impairments; ⑤ Patients allergic to the drugs used in the study; ⑥ Patients with severe primary diseases (such as tuberculosis, tumors and mental disorders), or those with postoperative lumbar infections.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suyun Liu

OTHER

Sponsor Role: lead

Responsible Party

Suyun Liu

Suyun Liu

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Suyun Liu, bachelor

Role: CONTACT

2466182790@qq.com

+86 13870649252

Other Identifiers

IIT-I-2025-062

Identifier Type: -

Identifier Source: org_study_id