Chronic Low Back Pain (Non-specific, Uncomplicated)
Conditions
Brief summary
This study aims to investigate the interactive effects of two core stability training strategies-abdominal drawing-in manoeuvre (ADIM) and Dynamic Neuromusculoskeletal Stabilization abdominal expansion (DNS-AE)-and two instructional approaches (verbal cueing and manual facilitation) on training outcomes in individuals with chronic non-specific low back pain. A 2×2 factorial randomized controlled trial design will be employed. Ninety-six participants with chronic non-specific low back pain will be randomly allocated, using block randomization, to one of four intervention groups in equal proportions. All groups will receive a 4-week intervention program, with training conducted twice per week. Outcome measures will be assessed at four time points: before the intervention (baseline), immediately after the first training session, at the completion of the 4-week intervention, and at a 3-month follow-up, to evaluate short-term and mid-term effects as well as the sustainability of training outcomes.
Interventions
BEHAVIORALAbdominal Drawing-In Manoeuvre Training
Abdominal drawing-in manoeuvre (ADIM) training is a core stability exercise strategy emphasizing selective activation and coordination of the deep abdominal musculature to enhance local trunk stability. Participants receive individualized, one-on-one training delivered by licensed physical therapists, conducted twice weekly for 4 weeks. Training is performed across functional positions and task-specific movements, with instruction provided using either verbal cueing or manual facilitation according to group allocation.
BEHAVIORALDynamic Neuromusculoskeletal Stabilization Abdominal Expansion Training
Dynamic Neuromusculoskeletal Stabilization abdominal expansion (DNS-AE) training focuses on coordinated breathing and abdominal expansion to facilitate intra-abdominal pressure regulation and integrated postural control. Participants receive individualized, one-on-one training delivered by licensed physical therapists, conducted twice weekly for 4 weeks. Training is performed across functional positions and task-specific movements, with instruction provided using either verbal cueing or manual facilitation according to group allocation.
Sponsors
National Yang Ming Chiao Tung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Clinically diagnosed with chronic non-specific low back pain, with symptoms persisting for more than 12 weeks. * Able to understand the study procedures and comply with the full intervention and assessment protocol.
Exclusion criteria
* History of surgery involving the lower back or lower extremities. * Presence of neurological symptoms, such as numbness or tingling sensations. * Signs or symptoms of nerve root compression. * History of any surgical procedure within the past 3 months. * Diagnosis of cancer. * Presence of major medical or psychiatric disorders. * Presence of systemic inflammatory disease. * Pregnancy. * Structural scoliosis of the spine. * Inability to ambulate or stand independently, or other conditions deemed unsuitable for participation. * Participation in any movement control-based exercise training within the past year. * Accumulated experience of more than 4 weeks of abdominal drawing-in manoeuvre (ADIM) training or Dynamic Neuromusculoskeletal Stabilization abdominal expansion (DNS-AE) training within the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | At baseline, after the first week of intervention, and at the end of the 4-week intervention. | Pain intensity assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable, with higher scores indicating greater pain intensity. |
| Movement control performance | At baseline, after the first week of intervention, and at the end of the 4-week intervention. | Movement control performance assessed using the Nine-Item Movement Control Test Battery, which evaluates movement quality during standardized functional movement tasks. Each item is scored according to predefined error-based criteria, and item scores are summed to produce a total score ranging from 0 to 93, with higher scores indicating poorer movement control performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability related to low back pain | At baseline, at the end of the 4-week intervention, and at 3-month follow-up. | Disability assessed using the Oswestry Disability Index (ODI), with total scores ranging from 0 %to 100%, where higher scores indicate greater disability. |
| Patient-specific functional ability | At baseline, at the end of the 4-week intervention, and at 3-month follow-up. | Functional ability assessed using the Patient-Specific Functional Scale (PSFS), with scores ranging from 0 to 10, where 0 indicates inability to perform the activity and 10 indicates the ability to perform the activity at the pre-injury or normal level, with higher scores indicating better functional ability. |
| Perceived movement difficulty assessed using the Perceived Difficulty Index (PDI). | At baseline, after the first week of intervention, and at the end of the 4-week intervention. | Perceived difficulty during movement performance assessed using the Perceived Difficulty Index (PDI). Participants rate the level of difficulty experienced during the movement tasks on a numeric rating scale ranging from 0 to 10, where 0 indicates no perceived difficulty and 10 indicates extreme difficulty, with higher scores indicating greater perceived difficulty. |
| Central sensitization symptoms | At baseline and at the end of the 4-week intervention. | Symptoms related to central sensitization assessed using the Central Sensitization Inventory (CSI), with total scores ranging from 0 to 100, where higher scores indicate greater symptom severity related to central sensitization. |
| Fear-avoidance beliefs | At baseline and at the end of the 4-week intervention. | Fear-avoidance beliefs assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ), with total scores ranging from 0 to 96, where higher scores indicate greater fear-avoidance beliefs. |
| Pain catastrophizing | At baseline and at the end of the 4-week intervention. | Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS), with total scores ranging from 0 to 52, where higher scores indicate greater pain catastrophizing. |
| Pressure pain threshold | At baseline and at the end of the 4-week intervention. | Pressure pain threshold (PPT) assessed using a pressure algometer. |
| Global perceived change | At the end of the 4-week intervention and at 3-month follow-up. | Overall perceived change assessed using the Global Rating of Change (GROC) scale, ranging from -7 to +7, where negative scores indicate perceived worsening, 0 indicates no change, and positive scores indicate perceived improvement, with higher scores indicating greater perceived improvement. |
| Learning acquisition during training | After each training session during the 4-week intervention. | Learning acquisition assessed by the instructor after each training session using a numeric rating scale from 0 to 10. |
Outcome results
None listed