Effects of a CSE With ADIM in Chronic Non-specific Low Back Pain With Lumbar Instability Using Telerehabilitation.

NCT06321393 | Completed

• 1 other identifier: HE662176
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the effectiveness of telerehabilitation-based and clinic-based methods to deliver a Core Stabilization Exercise Program with the Abdominal Drawing-In Maneuver Technique (CSE with ADIM) on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability. The main question it aims to answer is: Is there a difference between the effectiveness of telerehabilitation-based and clinic-based CSE with ADIM on pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability? Participants will perform a 7-week core stabilization exercise with the abdominal drawing-in maneuver technique, consisting of an exercise program for 20-minute sessions with 3 sessions per week. These exercise programs will be provided to the participants via a weekly video call with the main researcher as a telerehabilitation program. At the first session of each week, the researcher will provide supervision via video call with the participant for the exercise program. The participants will perform the exercise by following the video demonstration. After completing weekly training, participants will perform their exercise routine as part of their daily home program. If there is a comparison group: researchers will compare The control group (clinical-base group) will be provided the 7-week core stabilization exercise with abdominal drawing-in maneuver technique, the same as the experimental group, but control groups received the exercise program at the clinic according to the usual methods. At the first session of each week, an appointment will be set, and then the specific exercise for each week will be delivered and trained by the main researcher at the clinic. After completing weekly training, participants will perform their exercise routine as part of their daily home program to see if there are any differences in pain intensity, functional ability, quality of life, and satisfaction in chronic low back pain patients with lumbar instability between the experimental and control groups.

Conditions

Chronic Low-back Pain; Lumbar Instability

Keywords

Non-specific chronic low back pain with lumbar instability; lumbar instability

Outcome Measures

Primary Outcomes (1)

• 11-ponits Numerical Rating Scale (0-10 NRS)

  The 11-point numerical rating scale (0-10 NRS) will be used to assess low back pain intensity at rest. The NRS consists of a line or box scale with numbers in descending order, where 0 represents no pain and 10 represents the worst imaginable pain.

  Baseline and after Week 7

Secondary Outcomes (5)

• Oswestry disability index (ODI)

  Baseline and after Week 7

• Roland Morris Disability Questionnaire (RMDQ)

  Baseline and after Week 7

• 36-item Short Form Survey (SF-36)

  Baseline and after Week 7

• Lumbar joint reposition sense error

  Baseline and after Week 7

• Satisfaction questionnaire

  After Week 7

Study Arms (2)

Telerehabilitation-Based group

EXPERIMENTAL

A 7-week core stabilization exercise with abdominal drawing-in maneuver technique consist of 2 stages including the first stage (week 1-2) and the second stage (week 3-7) consisting of exercise program for 20-min sessions, with 3 sessions per week for 7 weeks. These exercise program will be provided to the participants via a weekly videocall with the main researcher as a telerehabilitation program.

Other: 7-week Core stabilization exercise with abdominal drawing-in maneuver technique

Clinic-Based group

ACTIVE COMPARATOR

The control group or clinic-base group will be provided the 7-week core stabilization exercise with abdominal drawing-in maneuver technique, the same as the experimental group, but control groups received the exercise program at the clinic according to the usual methods. At the first session of each week, an appointment will be set, and then the specific exercise for each week will be delivered and trained by the main researcher at the clinic. After completing weekly training, participants will perform their exercise routine as part of their daily home program.

Other: 7-week Core stabilization exercise with abdominal drawing-in maneuver technique

Interventions

7-week Core stabilization exercise with abdominal drawing-in maneuver technique OTHER

A 7-week core stabilization exercise with abdominal drawing-in maneuver technique consists of 2 stages, including the first stage (week 1-2) and the second stage (week 3-7) consisting of exercise program for 20-minute sessions with 3 sessions per week for 7 weeks. These exercise program will be provided to the participants via a weekly video call with the main researcher as a telerehabilitation program.

Clinic-Based group; Telerehabilitation-Based group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females.
• Aged between 18 - 60 years old.
• Onset of back pain lasting more than 12 weeks.
• Lumbar instability will be diagnosed using a score of at least 6 out of 14 on the Screening Tool for Patients with Lumbar Instability Questionnaire in Thai version.
• Presented at least two positive signs from three special tests of the following provocation tests: Painful catch, aberrant movement sign, or prone instability test.
• Pain intensity at rest has a pain level with a numerical rating scale (0-10 NRS) 3-7/10 points.
• Never receive the treatment by core stabilization exercise during 3 months before participate in this study.
• Participants must have a smart phone, tablet, or other electronic device with a camera and install the line application on the device. They can perform the basic operations of these devices by themselves.
• Participants have the ability to read and write Thai fluently.

You may not qualify if:

• Onset of serious spinal pathology: spinal fracture, spinal malignancy, or spinal infection.
• Have been diagnosed with osteoporosis, ankylosing spondylitis, or spondyloarthritis.
• History of spinal surgery and/or lower extremity.
• Cauda equina syndrome.
• Presented at least 2 out of 3 signs of neurological deficit including reflex abnormality or loss of sensation of lower limbs associated with the spinal nerve root and weakness of lower limbs (muscle power less than grade 3 using manual muscle test) (Macedo et al., 2008).
• Pregnancy or during breast feeding.
• Body mass index (BMI) \> 30 kg/m2.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Miss Chutimon Kongsa

Maha Sarakham, Mahasarakham, 44000, Thailand

Location

Study Officials

• Chutimon Kongsa

  Physical therapy Unit, Suddhavej Hospital, Faculty of Medicine, Mahasarakham UniversityMa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: February 1, 2024
• Primary Completion: April 9, 2025
• Study Completion: April 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

TH (1)