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Description for medicine or protocol of treatment in detail：
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1 Tuina Intervention
1.1 Tuina Practitioner
The Tuina Practitioners are all trained and experienced TCM practitioners.
1.2 Treatment Principle
Dredging the meridians and collaterals to provide pain relief by reducing the pain of muscle spasms, promoting qi and blood circulation, as well as soothing the muscles and regulating sinews and joints.
1.3 Regions and Points
Regions: Lumbosacral region, hip and lower limbs.
Main points: BL23 (shènshù), BL25 (dàchángshù), BL27 (xiǎochángshù), ashi point, BL40 (wěizhōng); GB30 (huántiào)
Adjunct acupoints according to syndrome:
Damp-heat syndromeGB34（Yáng Líng Quán）
Cold-damp syndrome: DU3 (yāoyángguān);
Static blood syndrome: BL17 (géshù)
Kidney deficiency syndrome: DU4 (mìngmén) and KI3 (tàixī);
1.4 Commonly used manipulations
Rolling, kneading, pushing, plucking, pointing, pulling-stretching, pulling, rotation, scrubbing, and patting.
1.5 Standardized Operating Procedures
The Tuina techniques that will be used for the treatment of CNLBP are as follows:
a. Dredging the meridians and collaterals: Ask the patient to take a prone position. Standing on one side of the patient, apply rolling manipulation from the lumbar region to the lower limbs. Apply palm root-kneading manipulation on spinal erector muscles on both sides of back and lumbosacral region. Continue kneading the lumbosacral and lower limb regions along the Bladder Meridian of Foot Taiyang. (10 minutes)
b. Pushing on the back and lumbosacral region: Ask the patient to take a prone position. Standing on one side of the patient, apply palm-pushing manipulation along the Governor Vessel (from DU14 (dàzhuī) to DU2 (yāoshù)) and bilateral courses of Bladder Meridian of Foot Taiyang (from BL11 (dàzhù) to BL30 (báihuánshù)) from the back to the lumbar region, for five times respectively. (2 minutes)
c. Plucking manipulation to relieve spasms: Ask the patient to take a prone position. Standing on one side of the patient, apply plucking manipulation with the thumb (Extend the thumb straight, the tip of the thumb is taken as the working point, the other four fingers are placed on the relative areas to assist the thumb, press the thumb on the side of tendons or muscles, then make a transverse plucking movement, perpendicular to the tendons or muscular fibers, like plucking the string of a music instrument) or plucking manipulation with the palm and thumb (Extend the thumb straight, the tip of the thumb is taken as the working point, the palm of the other hand is placed on the thumb (working point) to exert force, press the thumb on the side of tendons or muscles, then make a transverse plucking movement to the vertical tendons or muscular fibers, like plucking the string of a music instrument) on sacrospinalis muscles of back and lumbosacral region bilaterally. Repeat the manipulation up and down for several times, using an amount of strength that the patient can accept. The degree of treatment is based on the patient's tolerance level. (4 minutes)
d. Pointing-pressing acupoints to relieve pain: Ask the patient to take a prone position. Standing on one side of the patient, apply pointing-pressing manipulation on BL17 (géshù), BL23 (shènshù), BL25 (dàchángshù), BL27 (xiǎochángshù), ashi point, DU4 (mìngmén), DU3 (yāoyángguān), GB30 (huántiào), BL40 (wěizhōng), KI3 (tàixī), GB34（Yáng Líng Quán） (Selection of acupoints based on syndrome differentiation) located on the back, lumbosacral and leg region till the patient feels soreness and distention. (6 minutes)
e. Pulling-stretching manipulation of waist: Ask the patient to take a prone position and hold the top side of the bed with both hands forcefully, the tuina practitioner stands at the foot side of the bed to pull the patients body, by holding his ankles with both hands and gradually increasing force. The movements of pulling-stretching manipulation should be stable and gentle. The strength applied increases from mild to strong during pulling to avoid accidents. (1 minutes)
f. Pulling manipulation to adjust joints: The patient takes a lateral recumbent position, with the leg on the lower side extended and the upper leg bent at the hip and knee joint placed over the other leg. The Tuina practitioner places an elbow at the patients shoulder and the other on the back of the hip on the same side. Twist the patients waist by pushing the shoulder and pulling the hip in opposite directions until there is resistance. (2 minutes)
g. Rotating the waist to relax the lumbar muscles: The patient takes a supine position with flexed knees and hips. Pressing two knees with one hand to close the knees together and holding the lower parts or ankles of the legs with the other hand, rotate the bent legs clockwise or counterclockwise for 3-5 times respectively to lead the movement of the waist. (1 minutes)
h. Scrubbing manipulation to warm the back and lumbosacral region: Ask the patient to take a prone position. Standing on one side of the patient, apply scrubbing manipulation using the palm root of the hand (vertical scrubbing manipulation) along the bilateral courses of Bladder Meridian located on the back and lumbosacral region till a warm sensation is felt at the local area. Then apply scrubbing manipulation using the hypothenar region of the palm (transverse scrubbing manipulation) on the lumbosacral region until a warm sensation is felt at the local area. (3 minutes)
i. Patting the waist to end the treatment: Ask the patient to take a prone position. Standing on one side of the patient, apply patting manipulation on the lower back, lumbosacral, buttock and lower limb in regular rhythm. (1 minutes)
1.6 Tuina Treatment Course
Treatment will be given once weekly or biweekly as needed, each session lasting about 30-60 minutes, for 6 sessions, over a total of eight weeks.
2 Physiotherapy Intervention
2.1 Practicing Physiotherapists
The practicing Physiotherapists are licensed healthcare practitioners and have obtained the qualification certificate or registration from the relevant authorities for practice in their country of practice. These Physiotherapists should have at least 1 year of experience in the management of low back pain.
2.2 Standardized Operating Procedures
Physiotherapy treatment for chronic low back pain will follow the following general protocol:
2.2.1 Physiotherapy Assessment
(1) A detailed subjective assessment of the history of the pain, the nature of the pain and past treatment interventions is conducted.
(2) A psycho-social review of the subjects background is also conducted.
(3) A detailed objective assessment of the musculo-skeletal tissues to determine location of pain, range of motion, functional strength or gait analysis, tightness and any other loss of sensory or reflect responses.
2.2.2 Physiotherapy Intervention
(1) A provisional functional diagnosis of the subject is made, which will enable the Physiotherapist to decide on a treatment plan specific to the subjects symptoms.
(2) A treatment plan based on the symptoms and the dysfunction of the subject is developed through clinical reasoning and may include the following treatment options:
a. Manual therapy: Joint mobilization or manipulation may be used to reduce joint stiffness or pain from the low back.
i. Joint specific mobilization versus soft tissue mobilization as needed.
ii. Lumbar manipulation as needed.
b. Electrophysical agents (EPA): Various electrophysical agents may be used to reduce pain, muscle tension and joint stiffness.
i. The types of EPA are Heat therapy (from various heating devices, e.g. hot packs, infra-red lamps etc.), ice (e.g. using ice packs, ice cubes, ice sprays etc.), ultrasound therapy, transcutaneous electrical sensory stimulation, lumbar traction (if needed) etc.
c. Education: Advice on posture and positions for functions at work, home and for sporting activities may be provided to help with ongoing therapy after treatment.
i. Posture/body mechanics – basic and simplified
ii. Stay active – it is safe to do so
iii. Limit sedentary time (bed rest)
iv. Manage stress, sleep well, and eat well in an effort to reduce pain
d. Aerobic exercise:
i. Graded exposure to aerobic exercise will follow the recommended American College of Sports Medicine (ASCM) guidelines of 20 to 30 minutes at any intensity that achieves 55 to 90% of the maximum heart rate, at least 3 days a week.
ii. Examples of aerobic exercise: Walking, swimming, bicycling, etc. per patient comfort/preference
iii. Advance exercise intensity to 30 to 60 minutes per session, 5-7 days per week.
These exercises will not be performed in all PT sessions. Subjects will be instructed to achieve this on their own as part of a home exercise program. PT sessions are limited in time. These exercises are recommended for the subjects and are not necessarily done during each PT session.
e. Flexibility and core strengthening exercises (see below): A customized series of exercises to provide stretching of soft tissues and strengthening of the core muscles of the spine and peripheral tissues will be taught to the subject.
i. Low back stretch and rotation stretch
ii. Abdominal bracing
iii. Bridge
iv. Quadruped arm/leg lifts
v. Plank
2.3 Post Treatment Assessment
A detailed re-evaluation of the subjects pain, spinal ROM, functional assessment is conducted to evaluate the effectiveness of the session intervention and to plan for home exercise program and the next clinic appointment.
2.4 Home Exercise Program and Advice
Home exercises to maintain the effects of treatment will also be provided so that subject can continue their treatment at home. Exercise materials may be provided for the subject so that they can review the positions, duration and number of repetitions at home until the next therapy session.
3 Tuina Combined with Physiotherapy Treatment Intervention
3.1 Practicing Clinicians
As mentioned above.
3.2 Standardized Operating Procedures
Tuina treatment and PT treatment should not be performed on the same session. They may be provided to the subject within the same week or alternate weeks as prescribed by the clinicians. There is no need to stipulate the sequence for the treatment.
The same end point is used to discontinue therapy for these patients.
3.3 Treatment Course
As mentioned above, the combined Tuina and PT group will have 3 sessions of PT and 3 sessions of Tuina within the 2 months period.
3.4 Permitted and Prohibited Concomitant Treatments
Throughout the trial, participants will be discouraged from engaging with other forms of treatments of CNLBP, such as massage, Chiropractic, surgery etc. If subjects have residual pain and require further treatment, they will be recorded for data analysis and discussion. Any other form of treatment that subjects engage in for management of their back pain will also be required to be recorded in the case report form.
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Exclusion criteria：
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(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.
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