Clinical trial NCT06336993: Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP
Official title: Traditional Chinese Herbal Compound as Complementary Treatment for Non-specific Low Back Pain: A Randomized Controlled Trail Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Zhejiang Provincial Tongde Hospital
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: baseline, 1 week, 2 week, 3 week after treating
measure: Oswestry disability index
timeFrame: baseline, 1 week, 2 week, 3 week after treating
measure: Japanese Orthopaedic Association Scores
timeFrame: baseline, 1 week, 2 week, 3 week after treating
Secondary outcomes:
Other outcomes:
measure: the adverse reactions of digestive or other system
timeFrame: baseline, 1 week, 2 week, 3 week after treating
Locations:
city: Hangzhou
country: China
facility: Tongde Hospital
state: Zhejiang
Study officials:
References:
citation: Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
citation: Bernstein IA, Malik Q, Carville S, Ward S. Low back pain and sciatica: summary of NICE guidance. BMJ. 2017 Jan 6;356:i6748. doi: 10.1136/bmj.i6748. No abstract available.
citation: Oltean H, Robbins C, van Tulder MW, Berman BM, Bombardier C, Gagnier JJ. Herbal medicine for low-back pain. Cochrane Database Syst Rev. 2014 Dec 23;2014(12):CD004504. doi: 10.1002/14651858.CD004504.pub4.
citation: Zhan JW, Li KM, Zhu LG, Wang SQ, Feng MS, Wei X, Yu J, Tang B, Yin XL, Han T, Zhang P, Li LH, Chen M, Shao CC. Efficacy and Safety of Bushen Huoxue Formula in Patients with Discogenic Low-Back Pain: A Double-Blind, Randomized, Placebo-Controlled Trial. Chin J Integr Med. 2022 Nov;28(11):963-970. doi: 10.1007/s11655-022-3505-4. Epub 2022 Jul 15.