Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599645
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Impact of Combined CST BFR and Tai Chi on Muscle Physiology and Functional Characteristics Among Adults With LBP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Combined Core Stability Training Blood Flow Restriction and Tai Chi on Muscle Physiology and Functional Characteristics Among Adults With Low Back Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Low back pain LBP is highly prevalent globally affecting people of all agesWu et al 2020 In China LBP is a leading cause of disease burdenWu et al 2019 Exercise therapy such as core stability trainingCST Tai ChiTC and education are commonly recommended treatments but research on optimal protocols has been limited Blood flow restrictionBFR 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 BFRTai Chi on functional performance gait speed balance proprioception and postural sway among working adults with LBP
3 To determine the effects of combined CSTBFRTai Chi on pain intensity among working adults with LBP
4 To determine the effects of combined CSTBFRTai 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 ErrorJRE
6 APECS app
7 Y-Balance TestYBT
810-Meter Walk Test10MWT
9Visual Analogue Scale VAS
10Chinese version of the Fear-Avoidance Beliefs QuestionnaireFABQ-CHI
Interventions
Group A CSTBFRTai ChiEducation
Group B CSTBFREducation
Group C Tai Chi BFREducation
Group D CSTEducation
Sample size
Considering 30 drop out 52 participants 13 participants in each group
Statistical analysis
Data were processed using SPSS version 250 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 005
Low back pain LBP is highly prevalent globally affecting people of all agesWu et al 2020 In China LBP is a leading cause of disease burdenWu et al 2019 Exercise therapy such as core stability trainingCST Tai ChiTC and education are commonly recommended treatments but research on optimal protocols has been limited Blood flow restrictionBFR 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 BFRTai Chi on functional performance gait speed balance proprioception and postural sway among working adults with LBP
3 To determine the effects of combined CSTBFRTai Chi on pain intensity among working adults with LBP
4 To determine the effects of combined CSTBFRTai 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 ErrorJRE
6 APECS app
7 Y-Balance TestYBT
810-Meter Walk Test10MWT
9Visual Analogue Scale VAS
10Chinese version of the Fear-Avoidance Beliefs QuestionnaireFABQ-CHI
Interventions
Group A CSTBFRTai ChiEducation
Group B CSTBFREducation
Group C Tai Chi BFREducation
Group D CSTEducation
Sample size
Considering 30 drop out 52 participants 13 participants in each group
Statistical analysis
Data were processed using SPSS version 250 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 005
Detailed Description:
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 BFRTai Chi on functional performance gait speed balance proprioception and postural sway among working adults with LBP
3 To determine the effects of combined CSTBFRTai Chi on pain intensity among working adults with LBP
4 To determine the effects of combined CSTBFRTai Chi on fear among working adults with LBP
Test methods for each indicator
1 The RMS and MF value test by S-EMG
For each muscle double electrode sheets are put to the belly The electrode placement site is as follows ①Erecter spinae Open 2cm lateral to the midline of the trunk between the spinous process of the twelfth thoracic vertebra and the first lumbar vertebra ②Multifidus 2cm next to the L4-5 interspinous ③Rectus abdominis On both sides of the midline of the abdomen 3cm away from the navel ④Transversus abdominis Approximately 2 cm medial to the intersection of the vertical line traversing the anterior superior iliac spine and the lower border of the costal arch
Test action Back Bridge Side Bridge Abdominal Bridge Each action lasts 10 seconds and there is a 2-minute break between two adjacent actions to ensure that muscle weariness from the previous measurement does not interfere with the following measurement
S-EMG analysis It is the recording of electrical activity in muscles utilizing the BioForce surface electromyography tester model JE-TB1610 and the accompanying wireless data collection equipment The sampling frequency was 2000Hz the above three exercise groups lasted 10 seconds each and the original EMG signal was recorded for 10 seconds Use the InstallShield Wizard operating software to execute 10-500Hz noise processing on the original muscle electrical dataPerchthaler et al 2015 Then from the 3rd to the 7th second extract the data remove the baseline demodulate and smooth the original signal take the absolute value of the signal during the demodulation process and acquire the average value of the EMG data from the 3rd to the 7th second RMS value MF value
2 Transverses abdominus control test
In the case of muscle control which is quantified by PBU In the prone position the transversus abdominis will be tested The inflated cuff will be placed beneath the abdomen at the anterior superior iliac spine level The patient will be asked to draw in the lower abdomen without moving the upper stomach back or pelvis once the PBU has been inflated to 70 mm Hg Readings will be taken at the end of a 10-second contraction Two submaximal force tests will be performed to familiarise participants with each test position followed by two repeats of maximum isometric contraction For analysis the average of the two greatest contractions will be usedCairns et al 2000
3 Back extensor strength test
The participant will be seated on the treatment table with their head in the midline trunk straight arms along their body palms facing upwards and feet over the tables edge The dynamometer will be placed at the inferior angle of the scapulae in the center of the back between the shoulder blades The therapist will be above and to the side of the patient The test will be executed by the guidelines of Yang et al 2020 After obtaining the proper starting posture the participant will be asked to relax their arms lift their head and chest and push back against the dynamometer for 5 seconds with maximal force N
4 Lumbar proprioception test
The procedure utilized for the proprioception test was reported by Puntumetakul2018 The participant was seated 90 hips and knees with feet on the ground and hands on thighs and the examiner guided the participant into the neutral lumbar spine position The center of the 10-centimeter tape measure was placed on sacral segment 1 S1 as the measurements starting point The start point was marked by a laser pointer with a stable foundation The examiner advised the participant to remember the target position then perform the maximum anterior and posterior pelvic tilt twice holding each position for five seconds before returning to the neutral target position As a combined repositioning error deviation from the starting location was assessed in centimeters The participant received no feedback regarding any errors The participants practiced the relocation test twice before the evaluation This examination process was repeated three times with one-minute rest intervals in between For analysis the mean values will be employed
5 Trunk postural sway test
According to Trovato et al2020 APECS will record the participants in a standing stance for the 30s and participants will be asked to wear little clothes to reduce biases associated with incorrect landmark positioning during the postural analysis for the same reason trained clinicians will place markers on the participants bodies in correlation to the apps specified landmarks One video will be taken for the sagittal plane left Participants will be told to keep their feet the same width as their shoulders Finally the videos that meet the regulations will be imported into the video analysis system in APECS for analysis The maximum angle of the torso wobbles will be recorded and used for analysis
6 Standing dynamic balance test
While standing on one leg barefoot in a central location on the Y-Balance Test instrument with hands on the wing of the ilium the subjects will be asked to move the pointer as far as possible in three directions - anterior posteromedial and posterolateral All Y-Balance Test efforts will be made in the same order first in the anterior direction then in the posterolateral direction and finally in the posteromedial direction Participants moved the pointer with their dominant leg first The following is the measuring protocol Linek et al 2017 1 A training effort consists of four replications of the right and left lower limbs in each of three directions anterior posteromedial and posterolateral 2 Execution of the proper test which consisted of three attempts in each direction measuring the distance between the pointers closest location and the central plate Only when the individual tested was able to return to the starting location while fully controlling the movement was the result of each attempt saved During the performance of an attempt the following will be considered irregularities support using the movement-performing limb on the surface of the pointer to maintain balance pushing the pointer to achieve a better result changing the starting position taking the upper limbs off the iliac wing In such a case the participant repeated the attempt until three properly accomplished repetitions were obtained Linek et al 2017 For the analysis the maximum reach distance in each direction and the composite score are employed Picot et al 2021
7 Gait speed test
For gait speed a 10-meter walk test was used which required the participant to walk for 10 meters in a straight line at their normal speed with a 1-meter start-up before starting timing and a 1-meter stop-time timing It is permissible to employ an assistance walking device For the walking test each participant completed three consecutive trials The participants are told to walk at your normal comfortable pace until they reach the end of the indicated course The duration is recorded using a stopwatch which is started when the participants lead leg or assistive device crosses the first marker and stopped when the participants lead leg or assistive device crosses the second marker By dividing the distance of 8 m by the time recorded the recorded time is translated into walking speed ms
8 Fear avoidance belief test
The subject will next be allowed 3-5 minutes to respond to the FABQ-CHI Those who are unable to read will receive assistance
9 Pain test
Finally the subject will be allowed 2-3 minutes to respond to the VAS The following is the specific evaluation method Choose a 10 cm ruler and face the experimenter with it marked with a complete digital scale from 0 to 10 The patient only sees scales at both ends of the ruler and the 0 end is blank No pain implies no pain at all 14 means mild pain 56 means moderate discomfort 7 or more means severe pain and 10 signifies agonizing painLangley Sheppard 1985 When the low back pain arises on the 0 scale the patient begins to picture his pain state and the experimenter notes the ultimate number which can be immediately recorded as the patients pain intensity scoreWewers Lowe 1990
Rest for 30-60 seconds between tests to remove the confounding impact of weariness
Procedure
This study will screen subjects according to inclusion and exclusion criteria Before the evaluation and examination the physiotherapist will tell the participants the purpose and methods and the participants need to sign the consent form The demographic data which includes biographical information short questions concerning the occurrence of LBP and past medical history will then be recorded The subjects must then complete the anthropometric data such as weight height and BMI All patients require blood pressure and heart rate measurements before and after treatment
For all subjects the measurement indicators will be measured before the intervention six weeks after the treatment and 12 weeks after the treatment In addition all the subjects need to perform a warm-up before each exercise intervention and a cooldown after the exercise intervention Warm up includes walking 5 min and dynamic stretching 5 mins Cooldown includes static stretching 5 min
For group A subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up After the warm up the physical therapist will install the BFR device for the subject as required Then the patients will receive CST for 15 minutes Then they will receive Tai Chi practice for 15 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksZou Zhang Liu et al 2019
For group B subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up After the warm up the physical therapist will install the BFR device for the subject as required Then the patients will receive CST for 30 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksNipa et al 2022
For group C subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up After the warm up the physical therapist will install the BFR device for the subject as required Then the patients will receive Tai Chi for 30 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksQin et al 2019
For group D subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up Then the patients will receive CST for 30 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksNipa et al 2022
Statistical analysis
Data were processed using SPSS version 250 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 005
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 BFRTai Chi on functional performance gait speed balance proprioception and postural sway among working adults with LBP
3 To determine the effects of combined CSTBFRTai Chi on pain intensity among working adults with LBP
4 To determine the effects of combined CSTBFRTai Chi on fear among working adults with LBP
Test methods for each indicator
1 The RMS and MF value test by S-EMG
For each muscle double electrode sheets are put to the belly The electrode placement site is as follows ①Erecter spinae Open 2cm lateral to the midline of the trunk between the spinous process of the twelfth thoracic vertebra and the first lumbar vertebra ②Multifidus 2cm next to the L4-5 interspinous ③Rectus abdominis On both sides of the midline of the abdomen 3cm away from the navel ④Transversus abdominis Approximately 2 cm medial to the intersection of the vertical line traversing the anterior superior iliac spine and the lower border of the costal arch
Test action Back Bridge Side Bridge Abdominal Bridge Each action lasts 10 seconds and there is a 2-minute break between two adjacent actions to ensure that muscle weariness from the previous measurement does not interfere with the following measurement
S-EMG analysis It is the recording of electrical activity in muscles utilizing the BioForce surface electromyography tester model JE-TB1610 and the accompanying wireless data collection equipment The sampling frequency was 2000Hz the above three exercise groups lasted 10 seconds each and the original EMG signal was recorded for 10 seconds Use the InstallShield Wizard operating software to execute 10-500Hz noise processing on the original muscle electrical dataPerchthaler et al 2015 Then from the 3rd to the 7th second extract the data remove the baseline demodulate and smooth the original signal take the absolute value of the signal during the demodulation process and acquire the average value of the EMG data from the 3rd to the 7th second RMS value MF value
2 Transverses abdominus control test
In the case of muscle control which is quantified by PBU In the prone position the transversus abdominis will be tested The inflated cuff will be placed beneath the abdomen at the anterior superior iliac spine level The patient will be asked to draw in the lower abdomen without moving the upper stomach back or pelvis once the PBU has been inflated to 70 mm Hg Readings will be taken at the end of a 10-second contraction Two submaximal force tests will be performed to familiarise participants with each test position followed by two repeats of maximum isometric contraction For analysis the average of the two greatest contractions will be usedCairns et al 2000
3 Back extensor strength test
The participant will be seated on the treatment table with their head in the midline trunk straight arms along their body palms facing upwards and feet over the tables edge The dynamometer will be placed at the inferior angle of the scapulae in the center of the back between the shoulder blades The therapist will be above and to the side of the patient The test will be executed by the guidelines of Yang et al 2020 After obtaining the proper starting posture the participant will be asked to relax their arms lift their head and chest and push back against the dynamometer for 5 seconds with maximal force N
4 Lumbar proprioception test
The procedure utilized for the proprioception test was reported by Puntumetakul2018 The participant was seated 90 hips and knees with feet on the ground and hands on thighs and the examiner guided the participant into the neutral lumbar spine position The center of the 10-centimeter tape measure was placed on sacral segment 1 S1 as the measurements starting point The start point was marked by a laser pointer with a stable foundation The examiner advised the participant to remember the target position then perform the maximum anterior and posterior pelvic tilt twice holding each position for five seconds before returning to the neutral target position As a combined repositioning error deviation from the starting location was assessed in centimeters The participant received no feedback regarding any errors The participants practiced the relocation test twice before the evaluation This examination process was repeated three times with one-minute rest intervals in between For analysis the mean values will be employed
5 Trunk postural sway test
According to Trovato et al2020 APECS will record the participants in a standing stance for the 30s and participants will be asked to wear little clothes to reduce biases associated with incorrect landmark positioning during the postural analysis for the same reason trained clinicians will place markers on the participants bodies in correlation to the apps specified landmarks One video will be taken for the sagittal plane left Participants will be told to keep their feet the same width as their shoulders Finally the videos that meet the regulations will be imported into the video analysis system in APECS for analysis The maximum angle of the torso wobbles will be recorded and used for analysis
6 Standing dynamic balance test
While standing on one leg barefoot in a central location on the Y-Balance Test instrument with hands on the wing of the ilium the subjects will be asked to move the pointer as far as possible in three directions - anterior posteromedial and posterolateral All Y-Balance Test efforts will be made in the same order first in the anterior direction then in the posterolateral direction and finally in the posteromedial direction Participants moved the pointer with their dominant leg first The following is the measuring protocol Linek et al 2017 1 A training effort consists of four replications of the right and left lower limbs in each of three directions anterior posteromedial and posterolateral 2 Execution of the proper test which consisted of three attempts in each direction measuring the distance between the pointers closest location and the central plate Only when the individual tested was able to return to the starting location while fully controlling the movement was the result of each attempt saved During the performance of an attempt the following will be considered irregularities support using the movement-performing limb on the surface of the pointer to maintain balance pushing the pointer to achieve a better result changing the starting position taking the upper limbs off the iliac wing In such a case the participant repeated the attempt until three properly accomplished repetitions were obtained Linek et al 2017 For the analysis the maximum reach distance in each direction and the composite score are employed Picot et al 2021
7 Gait speed test
For gait speed a 10-meter walk test was used which required the participant to walk for 10 meters in a straight line at their normal speed with a 1-meter start-up before starting timing and a 1-meter stop-time timing It is permissible to employ an assistance walking device For the walking test each participant completed three consecutive trials The participants are told to walk at your normal comfortable pace until they reach the end of the indicated course The duration is recorded using a stopwatch which is started when the participants lead leg or assistive device crosses the first marker and stopped when the participants lead leg or assistive device crosses the second marker By dividing the distance of 8 m by the time recorded the recorded time is translated into walking speed ms
8 Fear avoidance belief test
The subject will next be allowed 3-5 minutes to respond to the FABQ-CHI Those who are unable to read will receive assistance
9 Pain test
Finally the subject will be allowed 2-3 minutes to respond to the VAS The following is the specific evaluation method Choose a 10 cm ruler and face the experimenter with it marked with a complete digital scale from 0 to 10 The patient only sees scales at both ends of the ruler and the 0 end is blank No pain implies no pain at all 14 means mild pain 56 means moderate discomfort 7 or more means severe pain and 10 signifies agonizing painLangley Sheppard 1985 When the low back pain arises on the 0 scale the patient begins to picture his pain state and the experimenter notes the ultimate number which can be immediately recorded as the patients pain intensity scoreWewers Lowe 1990
Rest for 30-60 seconds between tests to remove the confounding impact of weariness
Procedure
This study will screen subjects according to inclusion and exclusion criteria Before the evaluation and examination the physiotherapist will tell the participants the purpose and methods and the participants need to sign the consent form The demographic data which includes biographical information short questions concerning the occurrence of LBP and past medical history will then be recorded The subjects must then complete the anthropometric data such as weight height and BMI All patients require blood pressure and heart rate measurements before and after treatment
For all subjects the measurement indicators will be measured before the intervention six weeks after the treatment and 12 weeks after the treatment In addition all the subjects need to perform a warm-up before each exercise intervention and a cooldown after the exercise intervention Warm up includes walking 5 min and dynamic stretching 5 mins Cooldown includes static stretching 5 min
For group A subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up After the warm up the physical therapist will install the BFR device for the subject as required Then the patients will receive CST for 15 minutes Then they will receive Tai Chi practice for 15 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksZou Zhang Liu et al 2019
For group B subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up After the warm up the physical therapist will install the BFR device for the subject as required Then the patients will receive CST for 30 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksNipa et al 2022
For group C subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up After the warm up the physical therapist will install the BFR device for the subject as required Then the patients will receive Tai Chi for 30 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksQin et al 2019
For group D subjects will receive education from a qualified physiotherapist before the first treatment Subsequent treatment begins with a warm-up Then the patients will receive CST for 30 minutes Finally complete a 5-minute cooldown The above treatments are performed 3 times a week for 12 weeksNipa et al 2022
Statistical analysis
Data were processed using SPSS version 250 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None