NCT07318454

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 2Ă—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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

December 23, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

December 23, 2025

Last Update Submit

January 22, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    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.

    At baseline, after the first week of intervention, and at the end of the 4-week intervention.

  • Movement control performance

    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.

    At baseline, after the first week of intervention, and at the end of the 4-week intervention.

Secondary Outcomes (9)

  • Disability related to low back pain

    At baseline, at the end of the 4-week intervention, and at 3-month follow-up.

  • Patient-specific functional ability

    At baseline, at the end of the 4-week intervention, and at 3-month follow-up.

  • 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.

  • Central sensitization symptoms

    At baseline and at the end of the 4-week intervention.

  • Fear-avoidance beliefs

    At baseline and at the end of the 4-week intervention.

  • +4 more secondary outcomes

Study Arms (4)

ADIM With Verbal Cueing

EXPERIMENTAL

Participants receive abdominal drawing-in manoeuvre training with verbal cueing, delivered twice weekly for 4 weeks.

Behavioral: Abdominal Drawing-In Manoeuvre Training

ADIM With Manual Cueing

EXPERIMENTAL

Participants receive abdominal drawing-in manoeuvre training with manual facilitation, delivered twice weekly for 4 weeks.

Behavioral: Abdominal Drawing-In Manoeuvre Training

DNS-AE With Verbal Cueing

EXPERIMENTAL

Participants receive Dynamic Neuromusculoskeletal Stabilization abdominal expansion training with verbal cueing, delivered twice weekly for 4 weeks.

Behavioral: Dynamic Neuromusculoskeletal Stabilization Abdominal Expansion Training

DNS-AE With Manual Cueing

EXPERIMENTAL

Participants receive Dynamic Neuromusculoskeletal Stabilization abdominal expansion training with manual facilitation, delivered twice weekly for 4 weeks.

Behavioral: Dynamic Neuromusculoskeletal Stabilization Abdominal Expansion Training

Interventions

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.

ADIM With Manual CueingADIM With Verbal Cueing

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.

DNS-AE With Manual CueingDNS-AE With Verbal Cueing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physical Therapy, National Yang Ming Chiao Tung University

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01