Chronic Low-back PainNCT05136729
The Effects of Self-Natural Posture Exercise Programs on Chronic Low Back Pain
A study testing Self-Natural Posture Exercise training in people with Chronic Low-back Pain, run by Billings Clinic at 1 site in United States.
Trial summary
Low back pain is a major health problem across the United States, with socio-economic burden, major cause of disability, and poor quality of life. One such non-pharmacologic treatment is Self-Natural Posture Exercise (SNPE), a series of exercise programs developed in conjunction with orthodontic bracing principles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Self-Natural Posture Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 22 Mar 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:18-65 yr
- Body mass index (BMI): 18.5-34.9
- Low back disability index: 16-50% (moderate low back pain)
- Internet access with mobile device or desktop sufficient for video streaming
- No plan to have back pain treatment (opioid medication, physical therapy, and/or other procedures) in the next 12 months
Who cannot join
- Have had spine or pelvic orthopedic or neurologic surgery
- Have history or evidence of functionally significant musculoskeletal deformity
- Have history or evidence of functionally significant balance dysfunction
- Have a significant medical (e.g., cardiac or pulmonary) condition
- Are or plan to become pregnant
- Not currently receiving manual or physical interventions for low back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Face-to-Face vs Online Self-Natural Posture Exercise Programs on Chronic Low Back Pain
Low back pain is a major health problem across the United States, with socio-economic burden, major cause of disability, and poor quality of life. One such non-pharmacologic treatment is Self-Natural Posture Exercise (SNPE), a series of exercise programs developed in conjunction with orthodontic bracing principles. Belts are worn around the hips (pelvic correction belt) and legs (right posture belt) to assist with self-directed exercise and posture correction. A typical SNPE program has eight different movements, targeting the entire axial skeleton. The exercises can be practiced anywhere and are widely applicable to patients as exercises are low- to moderate-intensity flexibility-based muscle strength training. There are several studies from Korea examining the efficacy of SNPE; however, there are few English language studies and there are no studies from outside the country of South Korea. As such, there is little data the generalizability of SNPE, the degree of cultural acceptance in other countries, and the all-important adherence to the home exercise program. The present study proposes to be the first study outside of South Korea to examine the effects of SNPE on chronic low back patients.
Read the detailed description
The present study seeks to repeat the previously described positive clinical impact of SNPE in a new population, examine rates of adherence, and compare the effects of face-to-face versus online courses.
Specific Aims:
- Aim 1: Investigate the adherence to an SNPE program in American adults to explore the generalizability of existing Korean data.
- Aim 2: Assess the effects of a 12-week face-to-face vs online SNPE program on back pain. We hypothesize that the face-to-face group will show greater pain reduction and improvements in body posture and quality of life compared to the control group after phase 1.
- Aim 3: Compare adherence to and effects of face-to-face vs online 12-week SNPE programs.
- Aim 4: Investigate the adherence to and effects of face-to-face vs online 12-week SNPE programs at a follow-up of 12 weeks.
A single-blind randomized controlled trial (RCT) design with a wait-list control group will be used to evaluate the effect of SNPE for back pain reduction. The control group will receive online SNPE intervention after serving as an untreated comparison group. The wait-list control group serves two purposes. First, it provides an untreated comparison for the face-to-face group to determine if the intervention had an effect. By serving as a comparison group, researchers are able to isolate the independent variable and look at the impact it had. Second, it allows the wait-listed participants an opportunity to obtain the intervention at a later date.
Recruitment:
Flyers, Billings Clinic employee emails, and social media will be used to recruit participants. Recruitment messages will include relevant information about the study, benefits, and inclusion criteria as well as a link to a study-specific website recapitulating this information (https://xppizim.wixsite.com/snpestudy). When patients contact the investigators, any questions will be answered. If the patient chooses to go forward, the ODI Questionnaire and Self-reported Data Form will be collected online (www.surveymonkey.com). Data will be reviewed for eligibility, and if appropriate, participant will be sent the information contained on the consent form to review; the actual signed form will be collected at time of their 1st assessment prior to the collection of data.
After being assessed by a physiatrist, eligible participants will be invited to participate in the study. All participants will have an equal chance of being randomly assigned (using a random number table from Microsoft Excel to produce random numbers).
Analyses:
All data will be exported from www.surveymonkey.com and analyzed using the Statistical Package for Social Sciences (SPSS) application. Descriptive statistics will be used to summarize demographic variables. To investigate adherence mentioned in Aim 1 and 4, frequencies and percentages will be analyzed for categorical variables and mean, standard deviation, quartiles, and ranges for continuous variables. For Aim 2 and 3, all outcome measures will be compared between groups (Assessment 1 will be considered the baseline for face-to-face (FTF) and Assessment 2 will be the baseline for online (ONL)), will be analyzed using an analysis of covariance (ANCOVA) via the General Linear Model (GLM). Age and gender will be controlled as covariates. If there is a significant difference using ANCOVA, we will follow up with post hoc testing.
- Conditions
- Chronic Low-back Pain
- Being tested
- Self-Natural Posture Exercise training
- Keywords
- therapeutic, rehabilitation, stabilization, behavioral
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Natural Posture Exercise trainingBehavioural
Also called SNPE training
SNPE training will be provided face-to-face or online by certified instructors. The SNPE exercise training involves the use of special belts to align and stabilize posture and joints. Up to 4 belts can be used, placed around the hips, around the thighs, below the knees, and above the ankles. Myofascial release is part of the training, which is self-performed with SNPE equipment.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face Self-Natural Posture Exercise training | Experimental | Off-line training Receives: Behavioral: Self-Natural Posture Exercise training |
| Online Self-Natural Posture Exercise training | Active comparator | Virtual training
This group as a wait-list control group will receive online SNPE intervention after serving as an untreated comparison group. Receives: Behavioral: Self-Natural Posture Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline low back disability (measured by ODI) at week 0, 12, 24, and 36
Questionnaire: Oswestry Disability Index (ODI). Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Questionnaire examines perceived level of disability in 10 everyday activities of daily living.
Measured: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Mean change from baseline pain (measured by VAS) at week 0, 12, 24, and 36
The Visual Analog Scale (VAS). The pain VAS is a unidimensional measure of pain intensity. Patients rate their subjective pain on a scale from 0 to 10, with zero being no pain and 10 being the worst pain imaginable.
Measured: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Mean change from baseline quality of life (measured by SF-36) at week 0, 12, 24, and 36
The 36-Item Short Form Survey (SF-36). It is a 36 question self reported measure of health and crosses 8 domains including but not limited to physical, mental, and social health.
Measured: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Mean change from baseline muscle tone (measured by Myoton Pro device, in Hz) at week 0, 12, 24, and 36
Muscle tone is a biomechanical characteristic of a muscle and is measured as the muscle's natural vibration in a stable state without voluntary muscle contraction. This is expressed in frequency (㎐), and the higher the value, the higher the muscle tension. Muscle tone will be measured using a non-invasive muscle tone meter developed for objective quantification of the mechanical properties of muscles.
Measured: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Mean change from baseline pain (measured by FPX25 device, in kg/cm^2) at week 0, 12, 24, and 36
Pain by site will be evaluated by pressure pain threshold (PPT). PPT is defined as the minimum force applied which induces pain and is an indicator of sensitivity to pain. The examiner will place a flat circular (1㎠) probe attached to the digital pressure gauge vertically on the measured muscle and pressure will be gradually applied. When the examiner releases the probe, the pressure at the time of removal appears on the screen in units of kg/cm^2.
Measured: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Mean change from baseline body alignment (measured by dartfish software, in angular degrees) at week 0, 12, 24, and 36
Posture alignment will be evaluated by photographing standing posture of study participants from the front and side and images will be analyzed using Dartfish software.
Measured: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start17 Jan 2022
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind randomized controlled trial (RCT) design with a wait-list control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Billings Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- SNPE
- Responsible party
- Sponsor
- Investigators
- Younsun Son, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136729
- Sponsor's protocol ID
- 21.011
- Other IDs
- SNPE 09.02.2021
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Face-to-Face vs Online Self-Natural Posture Exercise Programs on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05136729
- Acronym / sponsor ID
- 21.011
- Conditions
- Chronic Low-back Pain
- Keywords
- therapeutic, rehabilitation, stabilization, behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Billings ClinicUniversity, hospital or other
- Collaborators
- SNPE
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 29 Nov 2021 (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.
Low back pain is a major health problem across the United States, with socio-economic burden, major cause of disability, and poor quality of life. One such non-pharmacologic treatment is Self-Natural Posture Exercise (SNPE), a series of exercise programs developed in conjunction with orthodontic bracing principles. Belts are worn around the hips (pelvic correction belt) and legs (right posture belt) to assist with self-directed exercise and posture correction. A typical SNPE program has eight different movements, targeting the entire axial skeleton. The exercises can be practiced anywhere and are widely applicable to patients as exercises are low- to moderate-intensity flexibility-based muscle strength training. There are several studies from Korea examining the efficacy of SNPE; however, there are few English language studies and there are no studies from outside the country of South Korea. As such, there is little data the generalizability of SNPE, the degree of cultural acceptance in other countries, and the all-important adherence to the home exercise program. The present study proposes to be the first study outside of South Korea to examine the effects of SNPE on chronic low back patients.
Detailed description
The present study seeks to repeat the previously described positive clinical impact of SNPE in a new population, examine rates of adherence, and compare the effects of face-to-face versus online courses.
Specific Aims:
- Aim 1: Investigate the adherence to an SNPE program in American adults to explore the generalizability of existing Korean data.
- Aim 2: Assess the effects of a 12-week face-to-face vs online SNPE program on back pain. We hypothesize that the face-to-face group will show greater pain reduction and improvements in body posture and quality of life compared to the control group after phase 1.
- Aim 3: Compare adherence to and effects of face-to-face vs online 12-week SNPE programs.
- Aim 4: Investigate the adherence to and effects of face-to-face vs online 12-week SNPE programs at a follow-up of 12 weeks.
A single-blind randomized controlled trial (RCT) design with a wait-list control group will be used to evaluate the effect of SNPE for back pain reduction. The control group will receive online SNPE intervention after serving as an untreated comparison group. The wait-list control group serves two purposes. First, it provides an untreated comparison for the face-to-face group to determine if the intervention had an effect. By serving as a comparison group, researchers are able to isolate the independent variable and look at the impact it had. Second, it allows the wait-listed participants an opportunity to obtain the intervention at a later date.
Recruitment:
Flyers, Billings Clinic employee emails, and social media will be used to recruit participants. Recruitment messages will include relevant information about the study, benefits, and inclusion criteria as well as a link to a study-specific website recapitulating this information (https://xppizim.wixsite.com/snpestudy). When patients contact the investigators, any questions will be answered. If the patient chooses to go forward, the ODI Questionnaire and Self-reported Data Form will be collected online (www.surveymonkey.com). Data will be reviewed for eligibility, and if appropriate, participant will be sent the information contained on the consent form to review; the actual signed form will be collected at time of their 1st assessment prior to the collection of data.
After being assessed by a physiatrist, eligible participants will be invited to participate in the study. All participants will have an equal chance of being randomly assigned (using a random number table from Microsoft Excel to produce random numbers).
Analyses:
All data will be exported from www.surveymonkey.com and analyzed using the Statistical Package for Social Sciences (SPSS) application. Descriptive statistics will be used to summarize demographic variables. To investigate adherence mentioned in Aim 1 and 4, frequencies and percentages will be analyzed for categorical variables and mean, standard deviation, quartiles, and ranges for continuous variables. For Aim 2 and 3, all outcome measures will be compared between groups (Assessment 1 will be considered the baseline for face-to-face (FTF) and Assessment 2 will be the baseline for online (ONL)), will be analyzed using an analysis of covariance (ANCOVA) via the General Linear Model (GLM). Age and gender will be controlled as covariates. If there is a significant difference using ANCOVA, we will follow up with post hoc testing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blind randomized controlled trial (RCT) design with a wait-list control group
| Arm | Type | Receives |
|---|---|---|
| Face-to-face Self-Natural Posture Exercise training | Experimental | Behavioral: Self-Natural Posture Exercise trainingOff-line training |
| Online Self-Natural Posture Exercise training | Active comparator | Behavioral: Self-Natural Posture Exercise trainingVirtual training This group as a wait-list control group will receive online SNPE intervention after serving as an untreated comparison group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age:18-65 yr
- Body mass index (BMI): 18.5-34.9
- Low back disability index: 16-50% (moderate low back pain)
- Internet access with mobile device or desktop sufficient for video streaming
- No plan to have back pain treatment (opioid medication, physical therapy, and/or other procedures) in the next 12 months
Key exclusion criteria (6 listed)
- Have had spine or pelvic orthopedic or neurologic surgery
- Have history or evidence of functionally significant musculoskeletal deformity
- Have history or evidence of functionally significant balance dysfunction
- Have a significant medical (e.g., cardiac or pulmonary) condition
- Are or plan to become pregnant
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 |
|---|---|---|
| Self-Natural Posture Exercise trainingAlso: SNPE trainingSNPE training will be provided face-to-face or online by certified instructors. The SNPE exercise training involves the use of special belts to align and stabilize posture and joints. Up to 4 belts can be used, placed around the hips, around the thighs, below the knees, and above the ankles. Myofascial release is part of the training, which is self-performed with SNPE equipment. | Behavioural | Face-to-face Self-Natural Posture Exercise training, Online Self-Natural Posture Exercise training |
Primary outcome
Mean change from baseline low back disability (measured by ODI) at week 0, 12, 24, and 36
Time frame: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Questionnaire: Oswestry Disability Index (ODI). Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. Questionnaire examines perceived level of disability in 10 everyday activities of daily living.
Mean change from baseline pain (measured by VAS) at week 0, 12, 24, and 36
Time frame: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
The Visual Analog Scale (VAS). The pain VAS is a unidimensional measure of pain intensity. Patients rate their subjective pain on a scale from 0 to 10, with zero being no pain and 10 being the worst pain imaginable.
Mean change from baseline quality of life (measured by SF-36) at week 0, 12, 24, and 36
Time frame: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
The 36-Item Short Form Survey (SF-36). It is a 36 question self reported measure of health and crosses 8 domains including but not limited to physical, mental, and social health.
Mean change from baseline muscle tone (measured by Myoton Pro device, in Hz) at week 0, 12, 24, and 36
Time frame: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Muscle tone is a biomechanical characteristic of a muscle and is measured as the muscle's natural vibration in a stable state without voluntary muscle contraction. This is expressed in frequency (㎐), and the higher the value, the higher the muscle tension. Muscle tone will be measured using a non-invasive muscle tone meter developed for objective quantification of the mechanical properties of muscles.
Mean change from baseline pain (measured by FPX25 device, in kg/cm^2) at week 0, 12, 24, and 36
Time frame: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Pain by site will be evaluated by pressure pain threshold (PPT). PPT is defined as the minimum force applied which induces pain and is an indicator of sensitivity to pain. The examiner will place a flat circular (1㎠) probe attached to the digital pressure gauge vertically on the measured muscle and pressure will be gradually applied. When the examiner releases the probe, the pressure at the time of removal appears on the screen in units of kg/cm^2.
Mean change from baseline body alignment (measured by dartfish software, in angular degrees) at week 0, 12, 24, and 36
Time frame: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).
Posture alignment will be evaluated by photographing standing posture of study participants from the front and side and images will be analyzed using Dartfish software.
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 22 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Younsun Son, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Natural Posture Exercise training in people with Chronic Low-back Pain, run by Billings Clinic at 1 site in United States.
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 5 inclusion and 6 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 22 Jun 2023. 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 United States. 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?
Mean change from baseline low back disability (measured by ODI) at week 0, 12, 24, and 36 (time frame: Specific metric will be gathered at outset of study and then after a 12 week intervention. It will be gathered again 12 weeks further out (24 weeks from outset). It will be gathered again 12 weeks further out (36 weeks).). 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?
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 22 Jun 2023.