About this trial
Background:
Low back pain (LBP) is highly prevalent globally, affecting people of all ages(Wu et al., 2020). In China, LBP is a leading cause of disease burden(Wu et al., 2019). Exercise therapy such as core stability training(CST), Tai Chi(TC) and education are commonly recommended treatments, but research on optimal protocols has been limited. Blood flow restriction(BFR) is beneficial for inducing muscle hypertrophy and promoting muscle strength (Hughes et al., 2019). Combined approaches using multiple modalities may provide added benefits but are understudied.
Research objectives:
1. To determine the effects of combined CST, BFR and Tai Chi on muscle physiology (muscle activation, muscle fatigue, back extensor strength, and transverses abdominus control) among working adults with LBP. 2. To determine the effects of combined CST+ BFR+Tai Chi on functional performance (gait speed, balance, proprioception, and postural sway) among working adults with LBP. 3. To determine the effects of combined CST+BFR+Tai Chi on pain intensity among working adults with LBP. 4. To determine the effects of combined CST+BFR+Tai Chi on fear among working adults with LBP.
Location of research:
Qianxinan Wutong Orthopedic Hospital, Guizhou Province, China
Instrumentations:
1. Demographic Data 2. Surface Electromyography (S-EMG) 3. Pressure Biofeedback Unit (PBU) 4. Back Extensor Strength Test (BEST) 5. Joint Repositioning Error(JRE) 6. APECS app 7. Y-Balance Test(YBT)
8.10-Meter Walk Test(10MWT)
9.Visual Analogue Scale (VAS)
10.Chinese version of the Fear-Avoidance Beliefs Questionnaire(FABQ-CHI)
Interventions:
Group A: CST+BFR+Tai Chi+Education;
Group B: CST+BFR+Education;
Group C: Tai Chi +BFR+Education;
Group D: CST+Education.
Sample size:
Considering 30% drop out. 52 participants. 13 participants in each group
Statistical analysis:
Data were processed using SPSS version 25.0 and Microsoft Excel 2010 software.
1. Demographic data = descriptive analytics. 2. All objectives = repeated measure ANCOVA (within-between interactions) for all variables. 3. The significant level is P \< 0.05.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All participants had stable vital signs, were cognizant, and had no cognitive impairment.
Aged 18-60 years old, able to understand Mandarin Chinese, and willing to cooperate.
LBP duration ≥ 3 months.
Be diagnosed as NLBP.
Disqualifiers
Patients with severe heart disease, liver disease, renal disease, pulmonary insufficiency, tumors, and postoperative dysfunction.
Patients who are unconscious and unable to cooperate.
Spinal fractures, severe arthritis, bony spinal stenosis, ankylosing spondylitis, open fractures, or unhealed traumatic wounds.
Patients who have not been diagnosed with NLBP.
Trial design
Parallel
Treatments tested in this trial
CST+BFR+Tai Chi+Education
Other intervention1. Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set. 2. Tai Chi: The first 10 Tai Chi movements from the 24-simplified Tai Chi form. Three qualified teachers will lead the training sessions. 3. Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow. 4. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
CST+BFR+Education
Other intervention1. Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set. 2. Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow. 3. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
Tai Chi +BFR+Education
Other intervention1. Tai Chi: The first 10 Tai Chi movements from the 24-simplified Tai Chi form. Three qualified teachers will lead the training sessions. 2. Blood Flow Restriction: The professional physical therapist puts on the cuff pneumatic tourniquet system(Kaastu Master) on the proximal end of the left lower limb of the subjects and gives a certain pressure through the Kaastu Master. The pressure needs to ensure that the venous return of the particapants is restricted to perfect ground, while the artery still has some blood flow. 3. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
CST+Education
Other intervention1. Core Stability Training: It includes core activation exercises (feed-forward control)(Libenson,2006). Each set will consist of 10 repetitions of this exercise with a 10-second hold. There will be a 30-second rest between repetitions and a 60-second rest after each set. 2. Education: After enrollment, patients will receive face-to-face education sessions at baseline, 30-45 min each time. Guided education by the same experienced professional physiotherapist.
Treatment groups
Trial outcomes
Primary outcomes
Core muscle activation by root mean square(RMS)
Root Mean Square (RMS) is a vector used to analyze the properties of electrical signal fluctuations, and the size of the RMS value represents the level of activity of a certain muscle(Abdelouahad et al., 2018). Absolute RMS demonstrated the highest overall dependability (ICC: 0.66-0.98) across activities (ICC: 0.66-0.98)(Van Helden et al., 2022).
Core muscle fatigue by mean frequency (MF)
Mean Frequency (MF) is a frequency-domain index that represents the midpoint of muscle fiber discharge frequency during skeletal muscle contraction. It is widely assumed that it is connected to the proportion of fast and slow fibers in muscle tissue. The multifidus muscle demonstrated good to outstanding reproducibility of initial MF and MF fatigue changes during Trunk Holding Tests (ICCwithindays =82%; ICCbetweendays =78%) (Ng \& Richardson, 1996).
Abdominal drawing-in maneuver by the pressure biofeedback unit (PBU)
The Pressure Biofeedback Unit (PBU) device consists of a pressure transducer with three airbags, a catheter, and a sphygmomanometer (with a range of 0 to 200 mmHg). It will be applied to evaluate abdominal drawing-in movements objectively (Grooms et al., 2013b). It is a trustworthy clinical instrument for assessing deep abdominal muscle function, with moderate to good (ICC = 0.47-0.82) and acceptable construct validity (ICC = 0.48-0.90) (P. O. D. P. Lima et al., 2011).
Back Extensor Strength by a push-pull dynamometer
A push-pull dynamometer will be applied to assess back extensor strength in the prone position. Because of its acceptable reliability (ICC=0.93), validity (r=0.54), and measurement errors, maximal isometric back extensor strength assessment in a prone posture can be applied to individuals with varying levels of back strength and may be the most useful for ranking back extensor strength in clinical and epidemiological studies (Yang et al., 2020).
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