TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis

NCT05273346 | Active Not Recruiting

• 1 other identifier: 2021DZMEC-123-02
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar degenerative disease is a common disease develops into degenerative lumbar spinal stenosis(DLSS)in the elderly and eventually. The long course of disease and other characteristics determine that conservative treatment cannot be effective in a short time, surgery is recommended to relieve symptoms quickly. However, the incidence of complications and disease recurrence rate after surgical treatment is high, and the reoperation rate is as high as 30-50%. Conservative treatment has the advantages of low price and high acceptance, so the treatment strategy first returns to conservative treatment.The complexity and repeatability of DLSS are the main reasons for the adoption of comprehensive treatment in modern medicine, but the efficacy is not significant. Traditional Chinese medicine (TCM) has its own theories and various methods to treat low back pain.

Conditions

Degenerative Lumbar Spinal Stenosis

Keywords

low back pain; leg pain; Spinal Stenosis

Outcome Measures

Primary Outcomes (2)

• The short-term response rate

  The NASS guidelines recommend the use of response rate as the primary criterion for determining performance due to the variety, complexity and repeatability of DLSS performance. The Zurich Claudication Questionnaire (ZCQ) is considered by the North American Spine Association (NASS) to be the best and most specific assessment method. It is the "gold standard" to evaluate the function of patients with lumbar spinal stenosis. Therefore, as the standard for calculating effective rate in this study, the decrease of symptom severity subscale and physiological function subscale score ≥0.5 points represents "success". A decrease of ≥2.5 points in the satisfaction subscale represents "success". When at least two subscales are judged to be "successful", the treatment is judged to be effective, thus the response rate is calculated.In ZCQ, the greater the difference between the two measurements before and after (the lower the score of the latter measurement), the better degree of recovery.

  The 3rd month

• The long-term response rate

  Using the Zurich Claudication Questionnaire (ZCQ) as the standard for calculating response rate in this study, the decrease of symptom severity subscale and physiological function subscale score ≥0.5 points represents "success". A decrease of ≥2.5 points in the satisfaction subscale represents "success". When at least two subscales are judged to be "successful", the treatment is judged to be effective, thus the response rate is calculated.In ZCQ, the greater the difference between the two measurements before and after (the lower the score of the latter measurement), the better degree of recovery.

  The 15rd month

Secondary Outcomes (4)

• Changes in pain level

  The time points of evaluation were baseline, 3,6,9,12 and 15 months.

• Changes in general health status

  The time points of evaluation were baseline, 3,6,9,12 and 15 months.

• Changes in locomotor function

  The time points of evaluation were baseline, 3,6,9,12 and 15 months.

• Incidence of surgery

  The evaluation time point was 3,6,9,12, and 15 months.

Study Arms (2)

Comprehensive Conservative TCM Treatment Group

EXPERIMENTAL

1. Traditional Chinese medicinal ointment; 2. Acupotomy; 3. Cupping therapy with bamboo cup; 4. Oral Chinese medicine granules.

Behavioral: Traditional Chinese medicinal ointment; Behavioral: Acupotomy; Behavioral: Cupping therapy with bamboo cup; Other: Oral Chinese medicine granules

Modern Medicine Conservative Treatment Program Group

ACTIVE COMPARATOR

1. Epidural Steroid Injections (ESIs); 2. Interferential current therapy; 3. Thermal therapy; 4. Oral painkillers.

Behavioral: Epidural Steroid Injections (ESIs); Behavioral: Interferential current therapy; Behavioral: Thermal therapy; Other: Oral painkillers

Interventions

Traditional Chinese medicinal ointment BEHAVIORAL

The Group1 will be treated using the Comprehensive Conservative TCM Treatment Group protocol.The special TCM ointment will be applied to the waist, and then Tuina, in order to play the comprehensive therapeutic role of Tuina and medicine, promoting blood circulation and removing stasis, warming and dispersing cold, strengthening tendons and strengthening bones, regulating qi and blood. The method of ointment is generally used with rubbing method, rubbing method, flat pushing method and kneading method. Treatment time: 7 minutes.

Comprehensive Conservative TCM Treatment Group

Acupotomy BEHAVIORAL

It is in the special acupoints or Ashixue for cutting, stripping and other different stimulation, in order to reduce the tension of soft tissue outside the spinal canal, reduce the trend of dynamic and static spinal canal stenosis, to achieve the purpose of relieving pain and removing disease, opening points and collaterals. Acupotomy can separate the adhesive tissue, which can improve the blood circulation of the local tissue and promote the absorption of inflammation. Most acupotomy points are tenderness points or induration points, such as yaojiaji and Shenshu. Treatment time: 3 minutes.

Comprehensive Conservative TCM Treatment Group

Cupping therapy with bamboo cup BEHAVIORAL

Put the bamboo cup with the thickness of the thumb into the cup and boil it, then find the meridian and select the acupoint, Pierce the skin with a needle at the appropriate acupoint, and remove the heated bamboo cup from the cup while it is hot. When the temperature of the steam in the bamboo cup is reduced, steam will condense into water quickly, which produces strong negative pressure. Through the medicinal force, heat and the suction of the bamboo cup, the blood stasis in the affected area is smoothly discharged, so that qi and blood can be unblocked and pain can be eliminated. Treatment time: 20 minutes.

Comprehensive Conservative TCM Treatment Group

Oral Chinese medicine granules OTHER

Oral Chinese medicine granules use to nourish liver and kidney, improve qi and blood. Patients voluntarily take it when they think it is necessary.

Comprehensive Conservative TCM Treatment Group

Epidural Steroid Injections (ESIs) BEHAVIORAL

The Group2 will be treated using the Modern Medicine Conservative Treatment Program Group protocol.All Epidural Steroid Injections(ESIs) will be performed by a physician in an outpatient surgical setting(a sterile operating room),the patient will be in prone position,while monitored the vital signs. After aseptic treatment, 1mg non-granular betamethasone plus 5mL 0.9% sodium chloride solution will be injected. Patients will repeat ESIs up to four times within three months after randomization, depending on the response to the previous ESIs, when the degree of pain increases or the degree of relief is less than 50%.

Also known as: ESIs

Modern Medicine Conservative Treatment Program Group

Interferential current therapy BEHAVIORAL

The 30-50cm padded electrode will be properly fixed on the left and right sides of the lumbar spinal stenosis, and the two groups of current will be crossed at the lesion. Constant frequency output 90Hz, frequency conversion output 90-100Hz, the current intensity is generally suitable for patient tolerance, each treatment for 10min, a total of 20 minutes. Twice a week for 3 months.

Modern Medicine Conservative Treatment Program Group

Thermal therapy BEHAVIORAL

After the interferential current therapy, the patient will receive Bohm light for 5 minutes at the site of lumbar spinal stenosis and massage for 5 minutes at low back. Twice a week for 3 months.

Modern Medicine Conservative Treatment Program Group

Oral painkillers OTHER

NSAID drugs, if necessary.

Modern Medicine Conservative Treatment Program Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic of Degenerative Lumbar Spinal Stenosis.
• Males and females aged between 40 and 85.
• Low back pain and leg pain accompanied by typical neurogenic intermittent claudication symptoms, lasting ≧3 months.
• The effect of 3 months conservative treatment(Oral painkillers + any 1 physical therapy) was not ideal(Less than 50% relief from pain or functional limitations).
• Having any of the following surgical indications: 1.Low back and leg pain after exercise, affecting life and work (the patient felt seriously affecting life and work);2. Progressive claudication(Continuous walking distance is less than 100m),or standing time is decreasing(Standing time at a time reduced to 50% of the onset);3. Those with obvious neurological defects(Suddenly appear the paresthesia of the distribution area of spinal nerve, such as numbness, acid bilges, acupuncture feeling, limb hair cool).
• The patient refused surgical treatment.
• Willing to participate in this study, and signed the informed consent.

You may not qualify if:

• Patients with vasogenic intermittent claudication.
• Patients with other bone and joint diseases, including spinal vertebra fracture, lumbar tuberculosis, spinal tumor and other lesions, or rheumatism, rheumatoid arthritis.
• Patients with hematopoietic system(anemia,aplastic anemia), cardiocerebral vascular system(History of cerebral hemorrhage, Serious cardiovascular disease), endocrine system(Poor glycemic control in diabetes, such as postprandial blood glucose over 12mmol/L) and other serious primary diseases, tumors and psychosis.
• Patients with scoliosis \>15° or disc instability (rotation \>10° or translation \>4mm).
• Patients after minimally invasive surgery and open surgery.
• Patients who received an epidural steroid injection within 6 months.
• The patient is allergic to Traditional Chinese medicine, history of skin allergy and allergic constitution.
• The treatment site has subcutaneous unknown lump, the skin is red and swollen broken ulceration inflammation or skin lesions, etc.
• Patients with severe cauda equina syndrome.
• Women who are menstruating, pregnant or breastfeeding.
• Patients with strong preferences for treatment, disobedience to random assignment, and poor compliance.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (1)

Dongzhimen hospital affiliated to Bejing University of Chinese Medicine

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Low Back Pain; Spinal Stenosis

Interventions

Acupuncture Therapy; Cupping Therapy; Electric Stimulation Therapy; Acetaminophen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Changhe Yu

  Beijing University of Chinese Medicine affiliated Dongzhimen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial is an open study. Subjects and physicians are not blinded, but outcome evaluators and statisticians are blinded. Doctors not involved in patient grouping and treatment will be appointed to evaluate the efficacy of patients. After locking the database, the third party statisticians who do not know the grouping should analyze it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 10, 2022
• Study Start: September 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)