NCT06859645

Brief Summary

Low back pain is a significant global health issue, affecting a large proportion of the population at some point in their lives. Among the different types of low back pain, non-specific low back pain is the most common. Chronic low back pain has been shown to impact trunk endurance, functional capacity, fatigue, anxiety, and depression levels. Neuroscience-based studies aimed at improving pain management have demonstrated that chronic pain is associated with not only peripheral changes but also central changes. These central changes include abnormalities in the distribution of sensory cortical processing, disinhibition of the motor cortex, and disturbances in body schema perception. Studies have shown that motor imagery training, defined as the mental simulation of movement without actual execution, functions as a cortical-level training method and has positive effects on impaired body schema perception, thereby reducing pain. A review of the literature indicates that motor imagery training contributes to the treatment of pathological pain syndromes such as complex regional pain syndrome, brachial plexus avulsion injury, phantom limb pain, distal radius fracture, and stroke by modulating cortical mechanisms. However, no randomized controlled trials have investigated the effectiveness of adding motor imagery training to exercise therapy in individuals with non-specific chronic low back pain, specifically regarding its impact on physical function and psychosocial parameters. The aim of this study is to investigate the effects of a motor imagery training protocol, applied in addition to exercise therapy, on pain, physical, and psychosocial parameters in individuals with non-specific chronic low back pain. A total of 32 individuals with chronic non-specific low back pain will be included in the study. Participants will be randomly assigned to either the intervention or control group. All participants will receive telerehabilitation-based exercise therapy under the supervision of a physiotherapist. In addition to the exercise therapy, participants in the intervention group will undergo asynchronous motor imagery training every day for eight weeks, while the control group will receive only exercise therapy. Assessments will be conducted three times: before treatment, at the end of the 8-week intervention, and at the 12th week follow-up. All assessments will be performed through a telerehabilitation-based approach. The study will evaluate participants' pain, fatigue, disability level due to low back pain, anxiety and depression levels, and physical function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2025

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

February 21, 2025

Last Update Submit

March 13, 2026

Conditions

Keywords

telerehabilitationmotor imagerylow back pain

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Scale

    The severity of general low back pain experienced by the participants in the last two days will be assessed numerically using the Numeric Pain Scale. Participants will be informed that a score of 0 represents "no pain at all," while a score of 10 represents "the most unbearable pain." Pain severity will be recorded numerically on a scale from 0 to 10.

    Baseline, at 8 week, at 12 week

Secondary Outcomes (9)

  • Oswestry Disability Index

    Baseline, at 8 week, at 12 week

  • Fatigue Severity Scale

    Baseline, at 8 week, at 12 week

  • Hospital Anxiety and Depression Scale

    Baseline, at 8 week, at 12 week

  • Sit-up Test

    Baseline, at 8 week, at 12 week

  • Modified Push-up Test

    Baseline, at 8 week, at 12 week

  • +4 more secondary outcomes

Study Arms (2)

Motor Imagery and Exercise Group

EXPERIMENTAL

Participants in the intervention group will follow a pre-designed motor imagery program in addition to the prescribed exercise training for eight weeks. This program will include exercise videos specifically targeting the lumbar region, along with synchronized audio recordings providing detailed explanations of the exercises. The exercise videos will initially consist of simple exercises and will progressively advance to more complex movements over the course of the intervention. Participants will receive new exercise videos weekly. Each session will last approximately 20-25 minutes, and participants will be required to complete the program daily.

Behavioral: Motor imagey trainingBehavioral: Exercise training

Exercise Group

ACTIVE COMPARATOR

Participants in the control group will receive only telerehabilitation-based exercise training under the supervision of a physiotherapist, twice a week for eight weeks.

Behavioral: Exercise training

Interventions

In addition to the prescribed exercise training, participants in the intervention group will follow a pre-designed motor imagery program for eight weeks, practicing daily. This program will include pre-recorded exercise videos specifically targeting the lumbar region, along with synchronized audio recordings providing detailed explanations of the exercises.

Motor Imagery and Exercise Group

All participants will receive telerehabilitation-based exercise training under the supervision of a physiotherapist for eight weeks. The exercise program will be delivered via videoconferencing as part of a telerehabilitation-based approach. The exercises, conducted under the physiotherapist's supervision, will consist of flexibility and stabilization exercises targeting the lumbar region and will last approximately 25 minutes per session.

Exercise GroupMotor Imagery and Exercise Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18 and 55 years old
  • Having a history of low back pain persisting for at least three months
  • Experiencing recurrent episodes of low back pain
  • Having a low back pain intensity score of 4 or higher on the Numeric Pain Rating Scale (NRS) out of 10 during both rest and activity
  • Having the ability to use a computer, tablet, or smartphone at a level sufficient to participate in assessments and treatment sessions via videoconference, or having a caregiver who can assist with this
  • Volunteering to participate in the study
  • Being able to read and understand Turkish

You may not qualify if:

  • A history of spinal surgery
  • Having traumatic low back injuries
  • Presence of severe comorbidities (neurological, neuromuscular, cardiological, psychiatric)
  • Presence of tumoral conditions
  • Having visual or hearing impairments
  • Presence of cognitive impairments
  • Receiving physiotherapy for low back pain within the last six months
  • Changes in pain medication within the last two months
  • Receiving additional treatments beyond routine care
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
M.Sc.

Study Record Dates

First Submitted

February 21, 2025

First Posted

March 5, 2025

Study Start

March 5, 2025

Primary Completion

August 1, 2025

Study Completion

November 14, 2025

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations