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Lumbar Disc HerniationsNCT07015658

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

A study testing Baduanjin, Moxibustion and Conventional intervention in people with Lumbar Disc Herniations, run by Suyun Liu.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lumbar Disc Herniations
What is being tested?
Baduanjin, Moxibustion and Conventional intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
1 Jun 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Suyun Liu, bachelor contact

+86 13870649252

2466182790@qq.com

About this study

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.

Being tested
Baduanjin, Moxibustion, Conventional intervention
Medical subject headings
Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaduanjinProcedure or surgery

    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.

  • MoxibustionProcedure or surgery

    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 interventionProcedure or surgery

    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.

Study groups in NCT07015658
Study groupRoleWhat they receive
Control GroupActive comparator1. 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.
Receives: Procedure: Conventional intervention
Baduanjin GroupExperimentalThe 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.
Receives: Procedure: Baduanjin; Procedure: Conventional intervention
Combined Intervention GroupExperimentalMoxibustion 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.
Receives: Procedure: Baduanjin; Procedure: Moxibustion; Procedure: Conventional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Japanese Orthopaedic Society,JOA

    JOA consists of three sections: daily life (0-14 points), subjective symptoms (0-9 points), and objective symptoms (0-6 points), with a total score of 29 points. The lower the score, the more obvious the functional impairment. The treatment improvement rate and efficacy are calculated based on the JOA score, using the formula: [(post-treatment score - pre-treatment score) ÷ (29 - pre-treatment score)] x 100%. Among them, an improvement rate of ≥ 75% is considered excellent; 50% - 74% is considered good; 25% - 49% is considered moderate improvement; 0% - 24% is considered poor. The efficacy judgment standard for the improvement rate is as follows: when the improvement rate is 100%, it is considered cured; when the improvement rate is greater than 60%, it is considered marked improvement; when it is 25% - 60%, it is considered effective; and when it is less than 25%, it is considered ineffective.

    Measured: The 1st day after the operation, 1 month after the operation, 3 months after the operation

Secondary outcomes (2)
  1. Hamilton anxiety scale,HAMA

    This is used to assess the severity of anxiety symptoms. A total score of less than 7 indicates no anxiety symptoms; a score greater than 7 suggests the presence of anxiety; a score of 14 or above indicates the existence of anxiety; a score of 21 or above indicates significant anxiety; and a score of 29 or above may indicate severe anxiety.

    Measured: The 1st day after the operation, 1 month after the operation, 3 months after the operation

  2. Visual Analogue Scale,VAS

    Draw a 10-centimeter horizontal line on the paper. Mark one end of the line as 0cm, indicating no pain at all; mark the other end as 10cm, representing severe pain. Place the side with the scale facing away from the patient. Ask the patient to make a mark at the corresponding position on this line. The recorded scale value is the degree of pain the patient felt at that moment.

    Measured: The 1st day after the operation, 1 month after the operation, 3 months after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015658
Sponsor's protocol ID
IIT-I-2025-062
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Baduanjin, Moxibustion and Conventional intervention in people with Lumbar Disc Herniations, run by Suyun Liu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suyun Liu, bachelor (+86 13870649252, 2466182790@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Japanese Orthopaedic Society,JOA (time frame: The 1st day after the operation, 1 month after the operation, 3 months after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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