The Effects of Self-Natural Posture Exercise Programs on Chronic Low Back Pain

NCT ID: NCT05136729

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2023-03-22

Brief 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. 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:

1. Aim 1: Investigate the adherence to an SNPE program in American adults to explore the generalizability of existing Korean data.

2. 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.

3. Aim 3: Compare adherence to and effects of face-to-face vs online 12-week SNPE programs.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Face-to-face Self-Natural Posture Exercise training

Off-line training

Group Type: EXPERIMENTAL

Self-Natural Posture Exercise training

Intervention Type: BEHAVIORAL

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.

Online Self-Natural Posture Exercise training

Virtual training

This group as a wait-list control group will receive online SNPE intervention after serving as an untreated comparison group.

Group Type: ACTIVE_COMPARATOR

Self-Natural Posture Exercise training

Intervention Type: BEHAVIORAL

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.

Interventions

Self-Natural Posture Exercise 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SNPE training

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SNPE

UNKNOWN

Sponsor Role: collaborator

Billings Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Younsun Son, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

Billings Clinic

Billings, Montana, United States

Countries

United States

Other Identifiers

SNPE 09.02.2021

Identifier Type: OTHER

Identifier Source: secondary_id

21.011

Identifier Type: -

Identifier Source: org_study_id