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

NCT05136729 | Completed

• 2 other identifiers: 21.011SNPE 09.02.2021
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

therapeutic; rehabilitation; stabilization; behavioral

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

Study Arms (2)

Face-to-face Self-Natural Posture Exercise training

EXPERIMENTAL

Off-line training

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.

Behavioral: Self-Natural Posture Exercise training

Interventions

Self-Natural Posture Exercise training 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.

Also known as: SNPE training

Face-to-face Self-Natural Posture Exercise training; Online Self-Natural Posture Exercise training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Billings Clinic: lead
• SNPE: collaborator

Study Sites (1)

Billings Clinic

Billings, Montana, 59101, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Younsun Son, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Care providers and investigators are blinded to outcome assessment. The de-identified data will be provided to the biostatistician for analysis. Analyzed data will be submitted to the PI for analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-blind randomized controlled trial (RCT) design with a wait-list control group

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 29, 2021
• Study Start: January 17, 2022
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)