- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07324538
Immediate Effects of Manual and Verbal Cueing During Movement Control Training in Chronic Non-Specific Low Back Pain
A Randomized Controlled Trial Comparing the Immediate Effects of Manual and Verbal Cueing During Movement Control Training in Individuals With Chronic Non-Specific Low Back Pain
Chronic non-specific low back pain is commonly associated with impaired movement control. Movement control training is often used in rehabilitation, and different cueing methods may influence how patients perform and learn movements.
The purpose of this randomized controlled trial is to compare the immediate effects of manual cueing and verbal cueing during movement control training in individuals with chronic non-specific low back pain. Participants will be randomly assigned to receive either manual cueing or verbal cueing during a standardized movement training session.
The study will examine immediate changes in movement control performance, perceived difficulty, and related clinical outcomes following the intervention. The results of this study may help clinicians better understand how different cueing strategies influence movement performance in people with chronic non-specific low back pain.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Clinically diagnosed chronic non-specific low back pain with symptoms lasting longer than 12 weeks
- Able to understand and comply with the assessment and intervention procedures
Exclusion Criteria:
- History of surgery involving the lower back or lower extremities
- Presence of neurological symptoms, such as paresthesia or numbness
- Signs or symptoms of nerve root compression
- History of surgery within the past 3 months
- History of cancer
- Presence of major medical or psychiatric disorders
- Presence of systemic inflammatory conditions
- Pregnancy
- Structural scoliosis
- Inability to walk or stand independently, or any condition deemed unsuitable for participation by the investigator
- Participation in any movement control exercise training within the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Manual Cueing Followed by Verbal Cueing
|
Movement Control Training with Manual Cueing involves hands-on guidance provided by the therapist to enhance movement quality during standardized movement control training. Verbal instructions are used only to explain the movement sequence, while manuel guidance is primarily applied to facilitate movement quality. Manual cueing is delivered according to the individual's needs and may include the following strategies:
Movement control training with verbal cueing involves the use of spoken instructions and verbal feedback provided by the therapist to facilitate movement quality during standardized movement control training. Physical contact is not used during the intervention. Verbal instructions are focused on key aspects of movement performance, including alignment and weight distribution, to support correct execution of the movement tasks. Examples of verbal cues include instructions such as maintaining the knee in a neutral position or directing attention to the distribution of load through the shoulder girdle during task performance. |
|
Experimental: Verbal Cueing Followed by Manual Cueing
|
Movement Control Training with Manual Cueing involves hands-on guidance provided by the therapist to enhance movement quality during standardized movement control training. Verbal instructions are used only to explain the movement sequence, while manuel guidance is primarily applied to facilitate movement quality. Manual cueing is delivered according to the individual's needs and may include the following strategies:
Movement control training with verbal cueing involves the use of spoken instructions and verbal feedback provided by the therapist to facilitate movement quality during standardized movement control training. Physical contact is not used during the intervention. Verbal instructions are focused on key aspects of movement performance, including alignment and weight distribution, to support correct execution of the movement tasks. Examples of verbal cues include instructions such as maintaining the knee in a neutral position or directing attention to the distribution of load through the shoulder girdle during task performance. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Control Performance
Time Frame: Immediately before and immediately after each intervention period
|
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.
|
Immediately before and immediately after each intervention period
|
|
Pain Intensity
Time Frame: Immediately before and immediately after each intervention period
|
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.
|
Immediately before and immediately after each intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Learning Effect
Time Frame: Immediately after each intervention period
|
Perceived learning following each intervention session, assessed by the therapist using a numeric rating scale from 0 (no learning) to 10 (complete mastery of key movement principles).
|
Immediately after each intervention period
|
|
Perceived Difficulty Index
Time Frame: Immediately after each intervention period
|
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.
|
Immediately after each intervention period
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NYCU114229AE-S2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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