Back; InstabilityNCT02974062
Immediate Effect of Core Stabilization Exercise on Trunk Proprioception in Healthy Individuals
A study testing Lumbar stabilization exercise in people with Back; Instability, run by Peemongkon Wattananon at 1 site in Thailand.
Trial summary
The purposes of this study were to 1) determine test-retest reliability of an iPhone application measurement and protocol, 2) establish minimal detectable change of an iPhone application measurement and protocol, and 3) determine the immediate effect of core stabilization exercise on trunk proprioception in healthy… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Back; Instability
- What is being tested?
- Lumbar stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 40
- No episode of back pain for 3 months prior to the participation
- No regular exercise routine that is composed of core stabilization exercise We select the age range between 18 and 40 years because one of the previous study demonstrated that patients with non-specific low back pain who had age below 40 years old were more likely to have clinical lumbar instability and would benefit from core stabilization exercise.15 In addition, patients older than 40 years old are more likely to have a specific low back condition,46 such as degenerative spine, spondylosis, or spinal stenosis, which may interfere with our interpretation of the effect of core stabilization exercise on trunk proprioception.
Who cannot join
- Clinical signs of systemic disease
- Definitive neurologic signs including weakness or numbness in the lower extremity
- Previous spinal surgery
- Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
- Pregnancy
- Any lower extremity condition that would potentially alter trunk movement
Show all 10Show fewer
- Vestibular dysfunction
- Extreme psychosocial involvement
- Body mass index (BMI) greater than 30 kg/m2
- Active treatment of another medical illness that would preclude participation in any aspect of the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
Official title: Immediate Effect of Core Stabilization Exercise on Trunk Proprioception in Healthy Individuals: A Feasibility Study
The purposes of this study were to 1) determine test-retest reliability of an iPhone application measurement and protocol, 2) establish minimal detectable change of an iPhone application measurement and protocol, and 3) determine the immediate effect of core stabilization exercise on trunk proprioception in healthy individuals.
Read the detailed description
This study used a sample of convenience between the ages of 18 - 40. Sixty healthy participants were recruited by flyers posted in 2 Mahidol university physical therapy clinics in Pinklao and Salaya, as well as word of mouth from participants and friend. Sample size calculation was performed using G*Power software (G*Power version 3.1.9.2, University Kiel, Germany). To our knowledge, no study has investigated the immediate effect of core stabilization exercise on trunk proprioception neither in healthy individuals, nor patients with low back pain. However, based on our clinical experiences, we expected to find an improvement (1-tailed) with a medium effect size (Cohen's d = 0.5); therefore, a total of 60 participants were required at confidence level (α) of .05 and power (1-β) of .80.
Participants who were interested in participation underwent a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If they met all inclusion criteria, the consent process was performed. To ensure they understood the study, they were simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form.
After the participants provided a written informed consent, all participants filled out the information sheet for demographic data. After that, they changed their cloth to lab tank top and shorts to expose only their lower back (L1 to S2). The body landmarks, including lumbar spine (L1) and sacrum (S2) were identified and marked with a skin pen for iPhone placement. Each iPhone was placed in the iPhone pocket with transparent film in order to see the iPhone monitor. The pockets were attached to the participant using a Velcro strap around his/her trunk and pelvis. These body landmark identification and iPhone placement process was performed by male or female investigator based upon participant's gender. Once the participant had completed setting up, the data collection process began.
Participants stood on a drawing paper with feet shoulder width apart. The foot print was drawn using a marker. This foot print was used for post-test positioning. The participants stood in a natural stance with arms down by sides. Participants were instructed to stand up straight and maintain that position for recording lumbar and sacral angles in neutral position. After recording, participants were instructed to perform 2 set of 3 repetitions of standing forward bend as far as they can and then return to upright position. Lumbar and sacral angles at full trunk flexion, as well as lumbar and sacral angles at completion of returning to upright were recorded for each repetitions. Data for each set were used to determine test-retest (intra-trial) reliability of an iPhone application, as well as establish minimal detectable change (intra-trial).
Participants underwent trunk proprioception test (pre-test) process by first performing practice trials. Participants performed trunk flexion at 30°, 45°, and 60° (4 repetitions for each degree) with feedback from investigators using those iPhones attached to lumbar spine and sacrum. This practice trials aimed for participants to get familiar with the testing protocol, as well as minimize the learning effect. After completion of practice trials, participants underwent pre-test data collection by perform 3 repetitions of trunk flexion at randomly selected angles each repetition (30°, 45°, and 60°) without feedback. Investigators recorded all lumbar and sacral angle data. After completion of pre-test data collection, all iPhones were removed and body landmarks were erased.
Each participant was randomized into either control or exercise group. Participants in control group waited for 15 minutes (newspaper and magazines were provided during waiting period), while participants in exercise group underwent the assessment of core stability in order to select an appropriate level of core stabilization exercise. After that, each participants in this group received a 30-minute of core stabilization exercise. Clinically, physical therapists would prescribe a 30-minute core stabilization exercise program for patients with non-specific low back pain. This exercise focuses on motor control rather than strength, endurance, or cardiovascular system.37 It is a low intensity exercise to develop an ability to automatically control co-contraction of deep abdominal and back muscles during functional movement. Therefore, the possibility of experiencing muscle fatigue is minimal. However, the participants were instructed to perform stretching exercise after the data collection was completed, and perform in following days as well.
Once participants in control group had finished 15-minute rest, and participants in exercise group had completed core stabilization exercise, they underwent practice trials and post-test data collection using the same protocol starting with marking all body landmarks. Data from test (first 2 sets of 3 repetitions) and retest (last 2 sets of 3 repetitions) from control group were used to determine test-retest (inter-trial) reliability, as well as derive minimal detectable change (inter-trial) of the protocol. Approximate time of the test protocol was 45 minutes including 15-minute rest period for the control group, whereas 60 minutes including 30-minute core stabilization exercise for the exercise group.
Rating of perceived exertion (RPE) and heart rate were used to monitor each participant throughout the protocol to avoid fatigue. Pre- and post-test data from the control and exercise groups were used to determine the immediate effect of core stabilization exercise.
All Statistical analyses were performed using statistical package for the social science (SPSS) software (IBM SPSS Statistics for Windows, Version 21.0. Armonk, New York, USA). Study objective 1 was to determine test-retest reliability of an iPhone application measurement and protocol. Mean angular displacement data from the iPhone application were used to calculate test-retest reliability by using intraclass correlation coefficient (ICC2,k) with confidence intervals. Significance level was held at .05 for all analysis. Study objective 2 was to establish minimal detectable change (MDC) of measurement. Minimal detectable change is defined as the smallest amount of change that likely reflects true change rather than measurement error from the iPhone application and protocol. Study objective 3 was to determine the immediate effect of a 30-minute core stabilization exercise on trunk proprioception in healthy individuals. Prior to utilization of statistical tests, descriptive statistics were performed and statistical assumptions were tested. Transformation will be performed if the data were not normally distributed. Appropriate statistical tests (parametric vs. non-parametric) were performed to determine the effects of 30-minute core stabilization exercise on trunk proprioception. Significance level was held at .05 for all analyses. Post-hoc power analysis was also performed.
- Conditions
- Back; Instability
- Being tested
- Lumbar stabilization exercise
- Keywords
- Position sense, Lumbar stabilization exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar stabilization exerciseOther
Participants were trained using lumbar stabilization exercise based on their initial lumbar stability level. They were received a 30-minute exercise for 1 session in this study.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar stabilization exercise | Experimental | Lumbar stabilization exercised is a low-intensity exercise that focuses on motor control of deep abdominal and back muscles, rather than their strength or endurance. There are 3 main levels in this exercise; 1) co-contraction of deep abdominal and back muscles, 2) co-contraction with limb movement (self-perturbation), and 3) co-contraction with functional movement (i.e. walking, running, etc.) Receives: Other: Lumbar stabilization exercise |
| Healthy control | No intervention | No intervention was given to this group of participants. They were asked to rest and wait for 15 minutes, then post-test was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar position sense
Absolute repositioning error measured by an iPhone application was used to determine change in lumbar position sense after 1 session (30 minutes) of lumbar stabilization exercise
Measured: Change from baseline lumbar position sense after receiving a 30-minute lumbar stabilization exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Back; InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peemongkon Wattananon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peemongkon Wattananon, Mahidol University
- Investigators
- Peemongkon Wattananon, PhD, Principal investigator, Faculty of Physical Therapy, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974062
- Sponsor's protocol ID
- 2016/016.2601
- Status last verified
- Mar 2017
- First submitted
- 21 Nov 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All data will be made available for other researchers after the end of the study.
Publications
Hebert JJ, Koppenhaver SL, Magel JS, Fritz JM. The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study. Arch Phys Med Rehabil. 2010 Jan;91(1):78-85. doi: 10.1016/j.apmr.2009.08.146.
PubMed 20103400O'Sullivan PB. Lumbar segmental 'instability': clinical presentation and specific stabilizing exercise management. Man Ther. 2000 Feb;5(1):2-12. doi: 10.1054/math.1999.0213.
PubMed 10688954
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Core Stabilization Exercise on Trunk Proprioception in Healthy Individuals: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02974062
- Acronym / sponsor ID
- 2016/016.2601
- Conditions
- Back; Instability
- Keywords
- Position sense, Lumbar stabilization exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peemongkon WattananonUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study were to 1) determine test-retest reliability of an iPhone application measurement and protocol, 2) establish minimal detectable change of an iPhone application measurement and protocol, and 3) determine the immediate effect of core stabilization exercise on trunk proprioception in healthy individuals.
Detailed description
This study used a sample of convenience between the ages of 18 - 40. Sixty healthy participants were recruited by flyers posted in 2 Mahidol university physical therapy clinics in Pinklao and Salaya, as well as word of mouth from participants and friend. Sample size calculation was performed using G*Power software (G*Power version 3.1.9.2, University Kiel, Germany). To our knowledge, no study has investigated the immediate effect of core stabilization exercise on trunk proprioception neither in healthy individuals, nor patients with low back pain. However, based on our clinical experiences, we expected to find an improvement (1-tailed) with a medium effect size (Cohen's d = 0.5); therefore, a total of 60 participants were required at confidence level (α) of .05 and power (1-β) of .80.
Participants who were interested in participation underwent a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If they met all inclusion criteria, the consent process was performed. To ensure they understood the study, they were simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form.
After the participants provided a written informed consent, all participants filled out the information sheet for demographic data. After that, they changed their cloth to lab tank top and shorts to expose only their lower back (L1 to S2). The body landmarks, including lumbar spine (L1) and sacrum (S2) were identified and marked with a skin pen for iPhone placement. Each iPhone was placed in the iPhone pocket with transparent film in order to see the iPhone monitor. The pockets were attached to the participant using a Velcro strap around his/her trunk and pelvis. These body landmark identification and iPhone placement process was performed by male or female investigator based upon participant's gender. Once the participant had completed setting up, the data collection process began.
Participants stood on a drawing paper with feet shoulder width apart. The foot print was drawn using a marker. This foot print was used for post-test positioning. The participants stood in a natural stance with arms down by sides. Participants were instructed to stand up straight and maintain that position for recording lumbar and sacral angles in neutral position. After recording, participants were instructed to perform 2 set of 3 repetitions of standing forward bend as far as they can and then return to upright position. Lumbar and sacral angles at full trunk flexion, as well as lumbar and sacral angles at completion of returning to upright were recorded for each repetitions. Data for each set were used to determine test-retest (intra-trial) reliability of an iPhone application, as well as establish minimal detectable change (intra-trial).
Participants underwent trunk proprioception test (pre-test) process by first performing practice trials. Participants performed trunk flexion at 30°, 45°, and 60° (4 repetitions for each degree) with feedback from investigators using those iPhones attached to lumbar spine and sacrum. This practice trials aimed for participants to get familiar with the testing protocol, as well as minimize the learning effect. After completion of practice trials, participants underwent pre-test data collection by perform 3 repetitions of trunk flexion at randomly selected angles each repetition (30°, 45°, and 60°) without feedback. Investigators recorded all lumbar and sacral angle data. After completion of pre-test data collection, all iPhones were removed and body landmarks were erased.
Each participant was randomized into either control or exercise group. Participants in control group waited for 15 minutes (newspaper and magazines were provided during waiting period), while participants in exercise group underwent the assessment of core stability in order to select an appropriate level of core stabilization exercise. After that, each participants in this group received a 30-minute of core stabilization exercise. Clinically, physical therapists would prescribe a 30-minute core stabilization exercise program for patients with non-specific low back pain. This exercise focuses on motor control rather than strength, endurance, or cardiovascular system.37 It is a low intensity exercise to develop an ability to automatically control co-contraction of deep abdominal and back muscles during functional movement. Therefore, the possibility of experiencing muscle fatigue is minimal. However, the participants were instructed to perform stretching exercise after the data collection was completed, and perform in following days as well.
Once participants in control group had finished 15-minute rest, and participants in exercise group had completed core stabilization exercise, they underwent practice trials and post-test data collection using the same protocol starting with marking all body landmarks. Data from test (first 2 sets of 3 repetitions) and retest (last 2 sets of 3 repetitions) from control group were used to determine test-retest (inter-trial) reliability, as well as derive minimal detectable change (inter-trial) of the protocol. Approximate time of the test protocol was 45 minutes including 15-minute rest period for the control group, whereas 60 minutes including 30-minute core stabilization exercise for the exercise group.
Rating of perceived exertion (RPE) and heart rate were used to monitor each participant throughout the protocol to avoid fatigue. Pre- and post-test data from the control and exercise groups were used to determine the immediate effect of core stabilization exercise.
All Statistical analyses were performed using statistical package for the social science (SPSS) software (IBM SPSS Statistics for Windows, Version 21.0. Armonk, New York, USA). Study objective 1 was to determine test-retest reliability of an iPhone application measurement and protocol. Mean angular displacement data from the iPhone application were used to calculate test-retest reliability by using intraclass correlation coefficient (ICC2,k) with confidence intervals. Significance level was held at .05 for all analysis. Study objective 2 was to establish minimal detectable change (MDC) of measurement. Minimal detectable change is defined as the smallest amount of change that likely reflects true change rather than measurement error from the iPhone application and protocol. Study objective 3 was to determine the immediate effect of a 30-minute core stabilization exercise on trunk proprioception in healthy individuals. Prior to utilization of statistical tests, descriptive statistics were performed and statistical assumptions were tested. Transformation will be performed if the data were not normally distributed. Appropriate statistical tests (parametric vs. non-parametric) were performed to determine the effects of 30-minute core stabilization exercise on trunk proprioception. Significance level was held at .05 for all analyses. Post-hoc power analysis was also performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar stabilization exercise | Experimental | Other: Lumbar stabilization exerciseLumbar stabilization exercised is a low-intensity exercise that focuses on motor control of deep abdominal and back muscles, rather than their strength or endurance. There are 3 main levels in this exercise; 1) co-contraction of deep abdominal and back muscles, 2) co-contraction with limb movement (self-perturbation), and 3) co-contraction with functional movement (i.e. walking, running, etc.) |
| Healthy control | No intervention | –No intervention was given to this group of participants. They were asked to rest and wait for 15 minutes, then post-test was performed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 40
- No episode of back pain for 3 months prior to the participation
- No regular exercise routine that is composed of core stabilization exercise We select the age range between 18 and 40 years because one of the previous study demonstrated that patients with non-specific low back pain who had age below 40 years old were more likely to have clinical lumbar instability and would benefit from core stabilization exercise.15 In addition, patients older than 40 years old are more likely to have a specific low back condition,46 such as degenerative spine, spondylosis, or spinal stenosis, which may interfere with our interpretation of the effect of core stabilization exercise on trunk proprioception.
Key exclusion criteria (10 listed)
- Clinical signs of systemic disease
- Definitive neurologic signs including weakness or numbness in the lower extremity
- Previous spinal surgery
- Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar stabilization exerciseParticipants were trained using lumbar stabilization exercise based on their initial lumbar stability level. They were received a 30-minute exercise for 1 session in this study. | Other | Lumbar stabilization exercise |
Primary outcome
Lumbar position sense
Time frame: Change from baseline lumbar position sense after receiving a 30-minute lumbar stabilization exercise
Absolute repositioning error measured by an iPhone application was used to determine change in lumbar position sense after 1 session (30 minutes) of lumbar stabilization exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 20103400Hebert JJ, Koppenhaver SL, Magel JS, Fritz JM. The relationship of transversus abdominis and lumbar multifidus activation and prognostic factors for clinical success with a stabilization exercise program: a cross-sectional study. Arch Phys Med Rehabil. 2010 Jan;91(1):78-85. doi: 10.1016/j.apmr.2009.08.146.
- Background: PubMed 10688954O'Sullivan PB. Lumbar segmental 'instability': clinical presentation and specific stabilizing exercise management. Man Ther. 2000 Feb;5(1):2-12. doi: 10.1054/math.1999.0213.
- Individual participant dataSharing planned: Yes. All data will be made available for other researchers after the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peemongkon Wattananon, PhD principal investigator
Faculty of Physical Therapy, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar stabilization exercise in people with Back; Instability, run by Peemongkon Wattananon at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar position sense (time frame: Change from baseline lumbar position sense after receiving a 30-minute lumbar stabilization exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02974062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.