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The Effectiveness of Tuina in Managing Chronic Non-specific Low Back Pain: A Protocol of a multi-center international Randomized Controlled Trial

Not Applicable
Recruiting
Conditions
Chronic Non-specific Low Back Pain
Registration Number
ITMCTR2000004087
Lead Sponsor
School of Traditional Chinese Medicine, Jinan University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Pain and discomfort of unknown etiology between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs), lasting for more than 12 weeks;
(2) There may be waist muscle weakness, stiffness, limited mobility or reduced spinal coordination. The symptoms of pain are lessened or disappeared after bed rest. While the symptoms of pain are aggravated after bending over, sedentary, or standing for a long time;
(3) Physical examination showed an increase in muscle tension or a significant localized tenderness point (trigger point) in the painful area, with negative straight-leg raising test, and no signs of nerve root lesions.
(4) Patients older than 21 years and younger than 75 years of both sexes.

Exclusion Criteria

(1) Patients with low back pain associated with nerve root compromise;
(2) Patients with severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
(3) Serious spinal pathologies such as fractures, tumors, inflammatory and infectious diseases;
(4) History of spine surgery;
(5) Serious cardiovascular or metabolic disorders, such as heart failure, severe osteoporosis;
(6) Patients diagnosed with cognitive issues such as major depression, and moderate to severe dementia severe psychiatric diseases (such as schizophrenia, bipolar affective disorder, paranoid psychosis);
(7) Women who are pregnant, or who are of childbearing potential and are likely to become pregnant during the treatment phase but are not willing to use a reliable form of contraception, will also be excluded. Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine device, surgical sterilization, and abstinence.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain;
Secondary Outcome Measures
NameTimeMethod
ODI score;SF-36 score;Adverse events;spinal ROM;
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