Instability; BackNCT03747185
Corticospinal Excitability of Deep Back and Abdominal Muscles
A study testing Lumbopelvic stiffening technique and Lumbopelvic relaxing technique in people with Instability; Back and Tightness of Back Muscles, run by Mahidol University at 1 site in Thailand.
Trial summary
This study aims to understand the roles of corticospinal excitability in controlling the trunk movement, and the clinical utility of clinical observation, as well as the effect of lumbopelvic stabilization during hamstrings muscle stretching. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Instability; Back, Tightness of Back Muscles
- What is being tested?
- Lumbopelvic stiffening technique and Lumbopelvic relaxing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 14 Dec 2018to 6 Jan 2020
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria for individuals without a history of clinical lumbar instability.
- Between the ages of 20 and 40
- No history of LBP that interferes with activities of daily living and/or required treatment
- The inclusion criteria for individuals with a history of clinical lumbar instability.
- Between the ages of 20 and 40
- A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
Show all 9Show fewer
- Presenting aberrant movement pattern during active forward bend test
- Passive straight leg raising test (SLR) greater than 91 degrees
- Having hamstrings muscle tightness of both legs (passive knee extension in supine with 90° hip flexion position greater than 20 degrees)
Who cannot join
- History of seizure for either the subject or any family member
- Implanted pacemaker
- Clinical signs of systemic disease
- Definitive neurologic signs including pain, weakness or numbness in the lower extremity
- Previous spinal surgery
- Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
Show all 14Show fewer
- Any lower extremity condition that would potentially alter trunk movement
- 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
- Menstruation or pregnancy (for female subject)
- Diagnosed herniated nucleus pulposus (HNP)
- Pain medication usage (e.g., NSAID)
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: Corticospinal Excitability of Deep Back and Abdominal Muscles in Individuals With History of Clinical Lumbar Instability
This study aims to understand the roles of corticospinal excitability in controlling the trunk movement, and the clinical utility of clinical observation, as well as the effect of lumbopelvic stabilization during hamstrings muscle stretching.
Read the detailed description
This study will use a sample of convenience between the ages of 20 and 40. Subjects with and without history of low back pain will be recruited by flyers posted in university physical therapy clinics in 2 locations, as well as word of mouth from subjects and friends. Subjects who are interested in participation will undergo a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If the participants meet all inclusion criteria, the consent process will be performed. To ensure the participants understand the study, the participants will be simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form. Total data collection including intervention between pre- and post-intervention will take approximately 2 hours.
After obtaining the written informed consent, all participants will fill out the information sheet for demographic data. Participant will have the right to refuse answering the demographic questionnaire, but the participants can participate in biomechanical data collection. Then, participants will asked to remove the metal accessories that could influence the electromagnetic field, change the cloth to lab tank top and shorts to expose the lower back and right knee, and wear the shoes throughout the test protocol. The body landmarks will be identified. These landmarks include 1) lumbar spine level 1 (L1), 2) sacrum level 2 (S2), 3) lateral epicondyle of right (RE) and left (LE) knees, and 4) head of fibula of right (RF) and left (LF) leg. These locations will be used to place motion sensors for outcome measures. The preparation process will take approximately 10 minutes.
The subjects will stand in a natural stance with arms down by sides. The participants will be instructed to perform functional movements including active forward bend, right and left straight leg raise tests, right and left hip abduction with knee flexion tests, quadruped backward rock test, prone with right and left knee flexion tests, prone with right and left hip internal/external rotation tests, prone with right and left hip extension tests. Each subject performs 2 trials of 3 consecutive repetitions of each functional movement tests. Heart rate and rating of perceive exertion (RPE) will be monitored after each functional movement tests. Two physical therapists (PT-A and PT-B), who are blinded to the group membership, will simultaneously observe and independently rate aberrant movement patterns. After physical therapists completing the clinical observation, the participants will hand the rating form to the principal investigator to input into a spreadsheet for further analysis. These data will be used to determine inter-rater reliability and diagnostic accuracy of clinical observation of aberrant movement patterns during functional movements to identify individuals with a history of CLI. The clinical observation will take about 20 minutes.
Prior to performing SLR, motion sensors will be placed on the subject's body landmarks. Subjects will be asked to perform one repetition of active forward bend, while motion data are simultaneously collected. Then, subjects will be asked to lay on the treatment table in supine position. PT-A will perform passive SLR, and maximal angle will be recorded. This SLR test is intended to determine whether the subject has a sign of CLI, rather than to assess neural tension (to rule out HNP and dural tension) or hamstrings muscle length. In participants with clinical lumbar instability, pelvis/hip will not be stabilized when performing passive SLR. In this case, when pelvis/hip has reached its restriction by hamstrings muscle tightness, lumbar spine would easily allow compensatory motion. Thus, leg raising greater than 91° would indicate clinical lumbar instability. This test is differed from hamstrings muscle tightness (passive knee extension in supine with 90° hip flexion position). This test the clinician will fix the pelvic/hip at 90°; therefore, compensatory motion from pelvis/hip will be minimized. After that, PT-A will perform hamstrings muscle length test. Subjects will be first asked to lay on the treatment table with tested hip and knee in 90 degrees flexion. PT-A will passively extend subject's knee to maximal tolerable point. Angle in sagittal plane between lateral epicondyle and head of fibula sensors will be measured to represent hamstrings muscle length. PT-A will perform additional clinical examination including modified Thomas test (muscle length test for iliopsoas, quadriceps, hip abductor, and hip adductor muscles), Ober's test (muscle length test for tensor fascia latae muscle), as well as abdominal and back muscle strength test assessed by a handheld dynamometer. These outcome measures will be assessed for baseline. To reduce the risk of muscle fatigue, the investigators will monitor heart rate and verbally ask the RPE during the test, and provide adequate resting period between repetitions. The clinical examination will take approximately 10 minutes.
After clinical data collection, the subjects will undergo corticospinal excitability measurement using transcranial magnetic stimulation (TMS). The investigator will identify transversus abdominis muscle (2 cm medial and 2 cm inferior to anterior superior iliac spine on the inguinal line), and lumbar multifidus muscle (2 cm lateral to lumbar spinous process of level 4). These locations will be used for EMG electrode placement. Before placing surface EMG electrodes, the skin will be lightly abraded using abrasive paper and cleaned using cotton with alcohol to lower the skin impedance. Electrodes will be aligned parallel to the muscle fibers. Then, Subjects will be seated comfortably in a reclined chair with both arms supported. The participants will be asked to wear a swim cap used to identify stimulation areas for transverse abdominis and lumbar multifidus muscles. The investigator will use a double cone coil to find the hotspot for both ipsilateral and contralateral to the pain in each muscle. Figure 1 illustrates TMS set up. After corticospinal excitability measurement, subjects will be randomly assigned into 2 groups (lumbopelvic stabilization, LPS and lumbopelvic relaxation, LPR). The TMS data collection will take approximately 60 minutes.
The subjects in both groups will perform hamstrings muscle stretching in standing position. The participants will be asked to place the heel on the tested leg on the compression load cell mounted on the adjustable treatment table. The adjustable treatment table will be initially set at the subject's knee level. Treatment table will gradually move up until force at the heel reaches 15% of the body weight. This standardized force will be controlled by the compression load cell. Our preliminary study indicates that 15% of the body weight is the maximal stretching force in which subjects have reported very hard level of exertion (16-18 out of 20) on RPE during stretching exercise. During applying stretching force, subjects in LPS will be asked to keep the lumbar and pelvic positions as rigid as possible without holding the breath, while subjects in LPR will be asked to relax the lumbopelvic region and do not hold against stretching force. Each subject will perform 4 repetitions of 30-second stretching with 15 seconds rest between repetitions.
After the intervention, the subjects will be reassessed for lumbopelvic motion during forward bend and hamstrings muscle length test. The intervention and reassessment process will take approximately 20 minutes. The data at baseline and post-intervention will be used to determine the effect of lumbopelvic stabilization during hamstring muscle stretching in individuals with and without a history of CLI. In addition, the investigator will call each subject for 1-year follow up to check whether subjects have any episode of low back pain and how often the participants have low back pain.
- Conditions
- Instability; Back, Tightness of Back Muscles
- Being tested
- Lumbopelvic stiffening technique, Lumbopelvic relaxing technique
- Keywords
- Clinical lumbar instability, History of low back pain, Corticospinal excitability, Stretching exercise, Movement system impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbopelvic stiffening techniqueOther
Participants will stretch the hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
Lumbopelvic relaxing techniqueOther
Participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Lumbopelvic stiffening technique | Experimental | Hamstring muscle stretching with lumbopelvic stiffening technique. Receives: Other: Lumbopelvic stiffening technique; Other: Lumbopelvic relaxing technique |
| Lumbopelvic relaxing technique | Active comparator | Hamstrings muscle stretching with lumbopelvic relaxing technique. Receives: Other: Lumbopelvic stiffening technique; Other: Lumbopelvic relaxing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting and active motor threshold
Resting and active motor threshold (MT) for ipsilateral and contralateral responses for transverse abdominis and lumbar multifidus muscles.
Measured: These data will be collected at baseline only.
Motor evoke potentials
Motor evoke potentials (MEP) for transverse abdominis and lumbar multifidus muscles.
Measured: These data will be collected at baseline only.
Center of gravity of Topography
Center of gravity coordinate of Topography of transverse abdominis and lumbar multifidus muscles.
Measured: These data will be collected at baseline only.
Volume of Topography
Volume of Topography of transverse abdominis and lumbar multifidus muscles.
Measured: These data will be collected at baseline only.
Clinical observation of aberrant movement.
Clinical observation of aberrant movement patterns during functional movement will be performed by two physical therapists.
Measured: These data will be collected at baseline only.
Motion data.
Clinical motion analysis system will be used to measure lumbar, pelvic, lumbopelvic, and knee motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.
Measured: These data will be measure at baseline and immediately after receiving stretching exercise technique.
Secondary outcomes (4)
Passive straight leg raising to test clinical lumbar instability
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Measured: These data will be collected at baseline only.
Muscle length based on modified Thomas and Trendelenburg test
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Measured: These data will be collected at baseline only.
Abdominal and back muscle strength .
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Measured: These data will be collected at baseline only.
1-year follow-up.
Participants will be call to check whether they have any episode of low back pain and how often they have low back pain.
Measured: 1 year after data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start14 Dec 2018
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Instability; BackStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to either stretching exercise with lumbopelvic stiffening technique or lumbopelvic relaxing technique. They will be provided a 2-day wash-out period. Then, participants will cross-over to another technique.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peemongkon Wattananon, Mahidol University
- Investigators
- Peemongkon Wattananon, PhD, Principal investigator, Faculty of Physical Therapy, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747185
- Sponsor's protocol ID
- 2018/128.2906
- Status last verified
- Feb 2020
- First submitted
- 13 Nov 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD of this study will be shared upon official request.
Publications
Tsao H, Galea MP, Hodges PW. Reorganization of the motor cortex is associated with postural control deficits in recurrent low back pain. Brain. 2008 Aug;131(Pt 8):2161-71. doi: 10.1093/brain/awn154. Epub 2008 Jul 18.
PubMed 18669505Tsao H, Tucker KJ, Hodges PW. Changes in excitability of corticomotor inputs to the trunk muscles during experimentally-induced acute low back pain. Neuroscience. 2011 May 5;181:127-33. doi: 10.1016/j.neuroscience.2011.02.033. Epub 2011 Feb 17.
PubMed 21333720Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
PubMed 16181938Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.
PubMed 29097026Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
PubMed 26240711
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticospinal Excitability of Deep Back and Abdominal Muscles in Individuals With History of Clinical Lumbar Instability
- ClinicalTrials.gov ID
- NCT03747185
- Acronym / sponsor ID
- 2018/128.2906
- Conditions
- Instability; Back, Tightness of Back Muscles
- Keywords
- Clinical lumbar instability, History of low back pain, Corticospinal excitability, Stretching exercise, Movement system impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 20 Nov 2018 (actual)
- 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.
This study aims to understand the roles of corticospinal excitability in controlling the trunk movement, and the clinical utility of clinical observation, as well as the effect of lumbopelvic stabilization during hamstrings muscle stretching.
Detailed description
This study will use a sample of convenience between the ages of 20 and 40. Subjects with and without history of low back pain will be recruited by flyers posted in university physical therapy clinics in 2 locations, as well as word of mouth from subjects and friends. Subjects who are interested in participation will undergo a screening process using inclusion-exclusion criteria checklist and receive brief information regarding the study. If the participants meet all inclusion criteria, the consent process will be performed. To ensure the participants understand the study, the participants will be simply asked regarding the study (i.e. objectives, benefits, etc.) before signing the consent form. Total data collection including intervention between pre- and post-intervention will take approximately 2 hours.
After obtaining the written informed consent, all participants will fill out the information sheet for demographic data. Participant will have the right to refuse answering the demographic questionnaire, but the participants can participate in biomechanical data collection. Then, participants will asked to remove the metal accessories that could influence the electromagnetic field, change the cloth to lab tank top and shorts to expose the lower back and right knee, and wear the shoes throughout the test protocol. The body landmarks will be identified. These landmarks include 1) lumbar spine level 1 (L1), 2) sacrum level 2 (S2), 3) lateral epicondyle of right (RE) and left (LE) knees, and 4) head of fibula of right (RF) and left (LF) leg. These locations will be used to place motion sensors for outcome measures. The preparation process will take approximately 10 minutes.
The subjects will stand in a natural stance with arms down by sides. The participants will be instructed to perform functional movements including active forward bend, right and left straight leg raise tests, right and left hip abduction with knee flexion tests, quadruped backward rock test, prone with right and left knee flexion tests, prone with right and left hip internal/external rotation tests, prone with right and left hip extension tests. Each subject performs 2 trials of 3 consecutive repetitions of each functional movement tests. Heart rate and rating of perceive exertion (RPE) will be monitored after each functional movement tests. Two physical therapists (PT-A and PT-B), who are blinded to the group membership, will simultaneously observe and independently rate aberrant movement patterns. After physical therapists completing the clinical observation, the participants will hand the rating form to the principal investigator to input into a spreadsheet for further analysis. These data will be used to determine inter-rater reliability and diagnostic accuracy of clinical observation of aberrant movement patterns during functional movements to identify individuals with a history of CLI. The clinical observation will take about 20 minutes.
Prior to performing SLR, motion sensors will be placed on the subject's body landmarks. Subjects will be asked to perform one repetition of active forward bend, while motion data are simultaneously collected. Then, subjects will be asked to lay on the treatment table in supine position. PT-A will perform passive SLR, and maximal angle will be recorded. This SLR test is intended to determine whether the subject has a sign of CLI, rather than to assess neural tension (to rule out HNP and dural tension) or hamstrings muscle length. In participants with clinical lumbar instability, pelvis/hip will not be stabilized when performing passive SLR. In this case, when pelvis/hip has reached its restriction by hamstrings muscle tightness, lumbar spine would easily allow compensatory motion. Thus, leg raising greater than 91° would indicate clinical lumbar instability. This test is differed from hamstrings muscle tightness (passive knee extension in supine with 90° hip flexion position). This test the clinician will fix the pelvic/hip at 90°; therefore, compensatory motion from pelvis/hip will be minimized. After that, PT-A will perform hamstrings muscle length test. Subjects will be first asked to lay on the treatment table with tested hip and knee in 90 degrees flexion. PT-A will passively extend subject's knee to maximal tolerable point. Angle in sagittal plane between lateral epicondyle and head of fibula sensors will be measured to represent hamstrings muscle length. PT-A will perform additional clinical examination including modified Thomas test (muscle length test for iliopsoas, quadriceps, hip abductor, and hip adductor muscles), Ober's test (muscle length test for tensor fascia latae muscle), as well as abdominal and back muscle strength test assessed by a handheld dynamometer. These outcome measures will be assessed for baseline. To reduce the risk of muscle fatigue, the investigators will monitor heart rate and verbally ask the RPE during the test, and provide adequate resting period between repetitions. The clinical examination will take approximately 10 minutes.
After clinical data collection, the subjects will undergo corticospinal excitability measurement using transcranial magnetic stimulation (TMS). The investigator will identify transversus abdominis muscle (2 cm medial and 2 cm inferior to anterior superior iliac spine on the inguinal line), and lumbar multifidus muscle (2 cm lateral to lumbar spinous process of level 4). These locations will be used for EMG electrode placement. Before placing surface EMG electrodes, the skin will be lightly abraded using abrasive paper and cleaned using cotton with alcohol to lower the skin impedance. Electrodes will be aligned parallel to the muscle fibers. Then, Subjects will be seated comfortably in a reclined chair with both arms supported. The participants will be asked to wear a swim cap used to identify stimulation areas for transverse abdominis and lumbar multifidus muscles. The investigator will use a double cone coil to find the hotspot for both ipsilateral and contralateral to the pain in each muscle. Figure 1 illustrates TMS set up. After corticospinal excitability measurement, subjects will be randomly assigned into 2 groups (lumbopelvic stabilization, LPS and lumbopelvic relaxation, LPR). The TMS data collection will take approximately 60 minutes.
The subjects in both groups will perform hamstrings muscle stretching in standing position. The participants will be asked to place the heel on the tested leg on the compression load cell mounted on the adjustable treatment table. The adjustable treatment table will be initially set at the subject's knee level. Treatment table will gradually move up until force at the heel reaches 15% of the body weight. This standardized force will be controlled by the compression load cell. Our preliminary study indicates that 15% of the body weight is the maximal stretching force in which subjects have reported very hard level of exertion (16-18 out of 20) on RPE during stretching exercise. During applying stretching force, subjects in LPS will be asked to keep the lumbar and pelvic positions as rigid as possible without holding the breath, while subjects in LPR will be asked to relax the lumbopelvic region and do not hold against stretching force. Each subject will perform 4 repetitions of 30-second stretching with 15 seconds rest between repetitions.
After the intervention, the subjects will be reassessed for lumbopelvic motion during forward bend and hamstrings muscle length test. The intervention and reassessment process will take approximately 20 minutes. The data at baseline and post-intervention will be used to determine the effect of lumbopelvic stabilization during hamstring muscle stretching in individuals with and without a history of CLI. In addition, the investigator will call each subject for 1-year follow up to check whether subjects have any episode of low back pain and how often the participants have low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either stretching exercise with lumbopelvic stiffening technique or lumbopelvic relaxing technique. They will be provided a 2-day wash-out period. Then, participants will cross-over to another technique.
| Arm | Type | Receives |
|---|---|---|
| Lumbopelvic stiffening technique | Experimental | Other: Lumbopelvic stiffening technique, Other: Lumbopelvic relaxing techniqueHamstring muscle stretching with lumbopelvic stiffening technique. |
| Lumbopelvic relaxing technique | Active comparator | Other: Lumbopelvic stiffening technique, Other: Lumbopelvic relaxing techniqueHamstrings muscle stretching with lumbopelvic relaxing technique. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The inclusion criteria for individuals without a history of clinical lumbar instability.
- The inclusion criteria for individuals with a history of clinical lumbar instability.
Key exclusion criteria (14 listed)
- History of seizure for either the subject or any family member
- Implanted pacemaker
- Clinical signs of systemic disease
- Definitive neurologic signs including pain, weakness or numbness in the lower extremity
- Previous spinal surgery
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 |
|---|---|---|
| Lumbopelvic stiffening techniqueParticipants will stretch the hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. | Other | Lumbopelvic relaxing technique, Lumbopelvic stiffening technique |
| Lumbopelvic relaxing techniqueParticipants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. | Other | Lumbopelvic relaxing technique, Lumbopelvic stiffening technique |
Primary outcome
Resting and active motor threshold
Time frame: These data will be collected at baseline only.
Resting and active motor threshold (MT) for ipsilateral and contralateral responses for transverse abdominis and lumbar multifidus muscles.
Motor evoke potentials
Time frame: These data will be collected at baseline only.
Motor evoke potentials (MEP) for transverse abdominis and lumbar multifidus muscles.
Center of gravity of Topography
Time frame: These data will be collected at baseline only.
Center of gravity coordinate of Topography of transverse abdominis and lumbar multifidus muscles.
Volume of Topography
Time frame: These data will be collected at baseline only.
Volume of Topography of transverse abdominis and lumbar multifidus muscles.
Clinical observation of aberrant movement.
Time frame: These data will be collected at baseline only.
Clinical observation of aberrant movement patterns during functional movement will be performed by two physical therapists.
Motion data.
Time frame: These data will be measure at baseline and immediately after receiving stretching exercise technique.
Clinical motion analysis system will be used to measure lumbar, pelvic, lumbopelvic, and knee motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.
4 secondary outcomes
Passive straight leg raising to test clinical lumbar instability
Time frame: These data will be collected at baseline only.
Muscle length based on modified Thomas and Trendelenburg test
Time frame: These data will be collected at baseline only.
Abdominal and back muscle strength .
Time frame: These data will be collected at baseline only.
1-year follow-up.
Time frame: 1 year after data collection.
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 20 Feb 2020.
- Background: PubMed 18669505Tsao H, Galea MP, Hodges PW. Reorganization of the motor cortex is associated with postural control deficits in recurrent low back pain. Brain. 2008 Aug;131(Pt 8):2161-71. doi: 10.1093/brain/awn154. Epub 2008 Jul 18.
- Background: PubMed 21333720Tsao H, Tucker KJ, Hodges PW. Changes in excitability of corticomotor inputs to the trunk muscles during experimentally-induced acute low back pain. Neuroscience. 2011 May 5;181:127-33. doi: 10.1016/j.neuroscience.2011.02.033. Epub 2011 Feb 17.
- Background: PubMed 16181938Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
- Background: PubMed 29097026Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.
- Background: PubMed 26240711Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
- Individual participant dataSharing planned: Yes. The IPD of this study will be shared upon official request.
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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 Lumbopelvic stiffening technique and Lumbopelvic relaxing technique in people with Instability; Back and Tightness of Back Muscles, run by Mahidol University 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 9 inclusion and 14 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 20 Feb 2020. 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?
Resting and active motor threshold (time frame: These data will be collected at baseline only.). The study lists 6 primary outcomes in all. 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 NCT03747185, which also lists 5 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 20 Feb 2020.