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Completed

NCT Number: NCT06336993

Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP

The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tongde Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a. Patients with low back pain who were seen between January 1, 2022 and June 16, 2023 were included;
  • b. meet the diagnostic criteria of NSLBP;
  • c. the age range was 20-90 years old;
  • d. agree to participate in the study and sign the informed consent;

Exclusion criteria

  • a. those who are unable to communicate normally, such as those suffering from mental and cognitive diseases, and cannot cooperate with the treatment;
  • b. pregnant or lactating women;
  • c. patients who are allergic to the treatment components or sulfonamides;
  • d. patients with a history of coronary artery bypass grafting;
  • e. patients with active gastrointestinal ulcer or bleeding;
  • f. patients with severe heart failure;
  • g. Patients with hepatic and renal insufficiency.

Treatment and study plan

herbal compound

Drug

patients were instructed to take the herbal compound twice a day for 3 weeks, 200 to 300ml each time, composition of herbal compound of BSTL was BaiShao 9g, ChuanNiuXi 15g, DanShen 15g, DiLong 9g, DuHuo 9g, DuZhong 15g, GouJi 15g, QinJiao 9g, SangJiSheng 15g, XiXianCao 9g, XuChangQin 9g and YanHuSuo 9g, and herbs were provided by the Traditional Chinese Medicine pharmacy of Tongde Hospital in Zhejiang Province.

Celecoxib

Drug

Celecoxib (Ouyi Pharmaceutical Co., LTD., H20203296) was used twice a day for 3 weeks, 200mg/ time, to treat NSLBP;

Primary outcomes

  1. Visual Analogue Scale

    Time frame: baseline, 1 week, 2 week, 3 week after treating

    The visual analogue scale (VAS) is used to assess pain. It is widely used in clinical practice worldwild. The basic method is to use a walking scale about 10cm long, marked with 10 scales on one side, and the two ends are respectively "0" and "10". 0 indicates no pain, and 10 indicates the most unbearable pain. A higher score means more intense pain.

  2. Oswestry disability index

    Time frame: baseline, 1 week, 2 week, 3 week after treating

    The Oswestry Disability Index (ODI) consists of 10 questions about pain intensity, self-care, lifting, walking, sitting, standing, disturbance of sleep, sexual life, social life, and travel, with six options for each question. The maximum score for each question is 5. Select the first option to score 0 points, select the last option to score 5 points, if there are 10 questions have been answered, the scoring method is: actual score /50 (highest possible score) × 100%, if there is a question not answered, the scoring method is: Actual score /45 (highest possible score) x 100%, if higher indicates more severe dysfunction.

  3. Japanese Orthopaedic Association Scores

    Time frame: baseline, 1 week, 2 week, 3 week after treating

    Japanese Orthopaedic Association Scores are evaluated from four aspects: conscious symptoms, objective examination, limit of daily activities and bladder function. Each part is composed of several questions, with 3-4 options for each question. The highest score for each question is 2 or 3 points. The overall score ranges from 0 to 29, with lower scores indicating greater dysfunction.

Other outcomes

  1. the adverse reactions of digestive or other system

    Time frame: baseline, 1 week, 2 week, 3 week after treating

    If the patient has a digestive or systemic adverse reaction, the patient's specific symptoms and timing will be recorded

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial Tongde Hospital

Other

Registry information

Official study title

Traditional Chinese Herbal Compound as Complementary Treatment for Non-specific Low Back Pain: A Randomized Controlled Trail Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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