Impact of Combined CST, BFR, and Tai Chi on Muscle Physiology and Functional Characteristics Among Adults With LBP

NCT06599645 | Not Yet Recruiting

• 1 other identifier: LPipeng
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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. 3.To determine the effects of combined CST+BFR+Tai Chi on pain intensity among working adults with LBP.
4. 4.To determine the effects of combined CST+BFR+Tai Chi on fear among working adults with LBP.
5. 5.Demographic Data
6. 6.Surface Electromyography (S-EMG)
7. 7.Pressure Biofeedback Unit (PBU)
8. 8.Back Extensor Strength Test (BEST)
9. 9.Joint Repositioning Error(JRE)
10. 10.APECS app
11. 11.Y-Balance Test(YBT)
12. 12.Demographic data = descriptive analytics.
13. 13.All objectives = repeated measure ANCOVA (within-between interactions) for all variables.
14. 14.The significant level is P \< 0.05.

Conditions

Low Back Pain

Keywords

Tai Ji; Core stability; Low back pain

Outcome Measures

Primary Outcomes (10)

• 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).

  Baseline (1st week), 6th week, and 12th week

• 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).

  Baseline (1st week), 6th week, and 12th week

• 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).

  Baseline (1st week), 6th week, and 12th week

• 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).

  Baseline (1st week), 6th week, and 12th week

• Postural sway by the mobile app APECS

  The application of a mobile app could represent a quick, safe, and accurate method for researchers and clinicians to evaluate general posture quantitatively. Adopting a movable and affordable tool for postural assessment could benefit the primary prevention of musculoskeletal disorders of the spine. The mobile app APECS-AI Posture Evaluation and Correction System® (New Body Technologies SAS, Grenoble, France) (APECS app) will be applied to evaluate the subject's postural sway in this study. The evaluation index is the maximum angle of the torso wobbles. According to a recommendation from a study, clinicians should consider APECS's worth as an auxiliary posture evaluation tool with (ICC \> 0.60) (Trovato et al., 2022).

  Baseline (1st week), 6th week, and 12th week

• Balance by Y-Balance Test

  The Y-Balance Test Kit will be applied to measure balance in this study. The device includes a single central plastic plate and three attached tubes positioned anteriorly, posteromedially, and posterolaterally. A measurement with a 0.5 cm spacing is placed on each of the tubes. A study found that the Y-Balance Test has high inter-rater reliability and validity for assessing dynamic balance in the CLBP group (Alshehre et al., 2021).

  Baseline (1st week), 6th week, and 12th week

• Lumbar proprioception by joint repositioning error(JRE)

  The primary result of proprioception was a joint repositioning error(JRE). The absolute error, constant error, and variable error can all be used to describe repositioning errors. We picked absolute error since it affects accuracy(Strimpakos et al., 2006), reflects the magnitude of the inaccuracy (Sheeran et al., 2012), and is the most widely used measurement (Tong et al., 2017). The proprioception test had great inter-rater reliability(ICC=0.61-0.76)(Petersen \& Rundquist, 2009).

  Baseline (1st week), 6th week, and 12th week

• Gait speed by the 10-meter walk test.

  The gait speed is measured using the 10-Meter Walk Test. The gait speed test is the most commonly used outcome measure to assess functional limitations of the lower limbs (Muñoz-Mendoza et al., n.d.). With ICC values ranging from 0.96 to 0.98, 10m gait speed measurement shows outstanding test-retest reliability(Peters et al., 2013).

  Baseline (1st week), 6th week, and 12th week

• Fear avoidance belief by the Chinese version of the Fear-avoidance Beliefs. Questionnaire (FABQ-CHI)

  The Chinese version of the Fear-avoidance Beliefs Questionnaire (FABQ-CHI) is a relatively basic, easy-to-understand, easy-to-use, low-cost, and comprehensive LBP evaluation tool. The FABQ-CHI was shown to have adequate factor structure, internal consistency, test-retest reliability, and construct validity. (Pei et al., 2010). The maximum possible score for each question is 6, the lowest possible score is 0, and the total score is 96. The higher the score, the greater the severity of the perceived fear-avoidance belief.

  Baseline (1st week), 6th week, and 12th week

• Pain by visual analogue scale (VAS)

  Visual Analogue Scale (VAS) is a 10 cm horizontal strip with numbers ranging from 0 to 10 (the most severe pain possible). This is one of the most dependable quantitative scales that is commonly utilized in research (Scrimshaw \& Maher, 2001). VAS has proven to be trustworthy and valid (ICC=0.49-0.83) (Crossley et al., 2004).

  Baseline (1st week), 6th week, and 12th week

Study Arms (4)

Group A

EXPERIMENTAL

CST+BFR+Tai Chi+Education

Other: CST+BFR+Tai Chi+Education

Group B

EXPERIMENTAL

CST+BFR+Education

Other: CST+BFR+Education

Group C

EXPERIMENTAL

Tai Chi +BFR+Education

Other: Tai Chi +BFR+Education

Group D

OTHER

CST+Education

Other: CST+Education

Interventions

CST+BFR+Tai Chi+Education OTHER

1. 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.

Group A

CST+BFR+Education OTHER

1. 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.

Group B

Tai Chi +BFR+Education OTHER

1. 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.

Group C

CST+Education OTHER

1. 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.

Group D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• VAS score ≤ 5 points.

You may not qualify if:

• 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.
• Unable to communicate and read in Chinese.
• Age \<18 \& \>60 years old.
• LBP duration \< 3 months.
• Patients with high blood pressure and abnormal heartbeat.
• VAS score \> 5 points.

Sponsors & Collaborators

• Universiti Teknologi Mara: lead

Related Publications (18)

• Abdelraouf OR, Abdel-Aziem AA. THE RELATIONSHIP BETWEEN CORE ENDURANCE AND BACK DYSFUNCTION IN COLLEGIATE MALE ATHLETES WITH AND WITHOUT NONSPECIFIC LOW BACK PAIN. Int J Sports Phys Ther. 2016 Jun;11(3):337-44.

  PMID: 27274419 BACKGROUND

• Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.

  PMID: 16339340 BACKGROUND

• Ainpradub K, Sitthipornvorakul E, Janwantanakul P, van der Beek AJ. Effect of education on non-specific neck and low back pain: A meta-analysis of randomized controlled trials. Man Ther. 2016 Apr;22:31-41. doi: 10.1016/j.math.2015.10.012. Epub 2015 Nov 2.

  PMID: 26585295 BACKGROUND

• Dos Santos LP, Santo RCDE, Ramis TR, Portes JKS, Chakr RMDS, Xavier RM. The effects of resistance training with blood flow restriction on muscle strength, muscle hypertrophy and functionality in patients with osteoarthritis and rheumatoid arthritis: A systematic review with meta-analysis. PLoS One. 2021 Nov 10;16(11):e0259574. doi: 10.1371/journal.pone.0259574. eCollection 2021.

  PMID: 34758045 BACKGROUND

• Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.

  PMID: 29573872 BACKGROUND

• Hughes L, Rosenblatt B, Haddad F, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B, Patterson SD. Comparing the Effectiveness of Blood Flow Restriction and Traditional Heavy Load Resistance Training in the Post-Surgery Rehabilitation of Anterior Cruciate Ligament Reconstruction Patients: A UK National Health Service Randomised Controlled Trial. Sports Med. 2019 Nov;49(11):1787-1805. doi: 10.1007/s40279-019-01137-2.

  PMID: 31301034 BACKGROUND

• Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.

  PMID: 29879638 BACKGROUND

• Paungmali A, Henry LJ, Sitilertpisan P, Pirunsan U, Uthaikhup S. Improvements in tissue blood flow and lumbopelvic stability after lumbopelvic core stabilization training in patients with chronic non-specific low back pain. J Phys Ther Sci. 2016 Jan;28(2):635-40. doi: 10.1589/jpts.28.635. Epub 2016 Feb 29.

  PMID: 27064327 BACKGROUND

• Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

  PMID: 28192789 BACKGROUND

• Qin J, Zhang Y, Wu L, He Z, Huang J, Tao J, Chen L. Effect of Tai Chi alone or as additional therapy on low back pain: Systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Sep;98(37):e17099. doi: 10.1097/MD.0000000000017099.

  PMID: 31517838 BACKGROUND

• Semeru GM, Halim MS. Acceptance versus catastrophizing in predicting quality of life in patients with chronic low back pain. Korean J Pain. 2019 Jan;32(1):22-29. doi: 10.3344/kjp.2019.32.1.22. Epub 2019 Jan 2.

  PMID: 30671200 BACKGROUND

• Smith BE, Littlewood C, May S. An update of stabilisation exercises for low back pain: a systematic review with meta-analysis. BMC Musculoskelet Disord. 2014 Dec 9;15:416. doi: 10.1186/1471-2474-15-416.

  PMID: 25488399 BACKGROUND

• Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.

  PMID: 30546064 BACKGROUND

• Wang R, Zhu D, Wang L, Liu J, Zou J, Sun Y, Jiang Y, Hu HY, Deng ZW, Weng LM, Zheng KY, Kiartivich S, Wang XQ. Tai Chi Quan Versus Physical Therapy on Pain and Cognitive Performance for Elderly People With Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial. Front Aging Neurosci. 2022 Jun 16;14:900430. doi: 10.3389/fnagi.2022.900430. eCollection 2022.

  PMID: 35783144 BACKGROUND

• Wang XQ, Xiong HY, Du SH, Yang QH, Hu L. The effect and mechanism of traditional Chinese exercise for chronic low back pain in middle-aged and elderly patients: A systematic review. Front Aging Neurosci. 2022 Oct 10;14:935925. doi: 10.3389/fnagi.2022.935925. eCollection 2022.

  PMID: 36299610 BACKGROUND

• Wu A, Dong W, Liu S, Cheung JPY, Kwan KYH, Zeng X, Zhang K, Sun Z, Wang X, Cheung KMC, Zhou M, Zhao J. The prevalence and years lived with disability caused by low back pain in China, 1990 to 2016: findings from the global burden of disease study 2016. Pain. 2019 Jan;160(1):237-245. doi: 10.1097/j.pain.0000000000001396.

  PMID: 30234697 BACKGROUND

• Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175.

  PMID: 32355743 BACKGROUND

• Yue YS, Wang XD, Xie B, Li ZH, Chen BL, Wang XQ, Zhu Y. Sling exercise for chronic low back pain: a systematic review and meta-analysis. PLoS One. 2014 Jun 11;9(6):e99307. doi: 10.1371/journal.pone.0099307. eCollection 2014.

  PMID: 24919119 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Zarina Zahari, Doctor

  Centre of Physiotherapy, Faculty of Health Sciences, Universiti Teknologi MARA, Malaysia

  STUDY DIRECTOR

Central Study Contacts

Lin Pipeng, Master

CONTACT

86-15513697108; 137793134@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion: May 8, 2025
• Study Completion: July 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share