Trial Outcomes & Findings for Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain (NCT NCT02645760)
NCT ID: NCT02645760
Last Updated: 2016-10-06
Results Overview
The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)
COMPLETED
NA
38 participants
baseline an week 7
2016-10-06
Participant Flow
Participant milestones
| Measure |
Core Stabilization Exercise
7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
|
Conventional Treatment
7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
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|---|---|---|
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Overall Study
STARTED
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19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain
Baseline characteristics by cohort
| Measure |
Core Stabilization Exercise
n=19 Participants
7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
|
Conventional Treatment
n=19 Participants
7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
39.63 years
STANDARD_DEVIATION 10.26 • n=93 Participants
|
37.89 years
STANDARD_DEVIATION 10.60 • n=4 Participants
|
38.76 years
STANDARD_DEVIATION 10.33 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
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BMI
|
24.97 kg/m^2
STANDARD_DEVIATION 3.07 • n=93 Participants
|
24.03 kg/m^2
STANDARD_DEVIATION 4.08 • n=4 Participants
|
24.50 kg/m^2
STANDARD_DEVIATION 3.71 • n=27 Participants
|
PRIMARY outcome
Timeframe: baseline an week 7Population: Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group.
The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)
Outcome measures
| Measure |
Core Stabilization Exercise
n=19 Participants
7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
|
Conventional Treatment
n=19 Participants
7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
|
|---|---|---|
|
Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7
|
1.32 units on a scale
Standard Deviation 1.83
|
3.63 units on a scale
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: baseline and week 7Population: Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group
This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score
Outcome measures
| Measure |
Core Stabilization Exercise
n=19 Participants
7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
|
Conventional Treatment
n=19 Participants
7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
|
|---|---|---|
|
Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7
|
1.53 units on a scale
Standard Deviation 2.29
|
4.89 units on a scale
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: baseline and week 7Population: Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group
Modified-modified Schober's test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)
Outcome measures
| Measure |
Core Stabilization Exercise
n=19 Participants
7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
|
Conventional Treatment
n=19 Participants
7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
|
|---|---|---|
|
Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7
|
5.32 centimeter
Standard Deviation 1.51
|
4.32 centimeter
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: baseline and week 7Population: Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group
This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)
Outcome measures
| Measure |
Core Stabilization Exercise
n=19 Participants
7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
|
Conventional Treatment
n=19 Participants
7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
|
|---|---|---|
|
Change From Baseline in Repositioning Error on Repositioning Test at Week 7
|
0.43 centimeter
Standard Deviation 0.34
|
0.67 centimeter
Standard Deviation 0.42
|
Adverse Events
Core Stabilization Exercise
Conventional Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place