NCT05049772

Brief Summary

Low back pain is a common problem in society and causes loss of workforce. Its lifetime prevalence reaches 80% and annual hospital admission rates in the adult population reach 15%.Most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. Studies have shown that similar brain regions are activated during motor imagery and real movement. However, the level of evidence about the effect of motor imagery on autonomic functions is limited. Today, interest in telerehabilitation has increased due to the Covid-19 pandemic. The aim of this study is to examine the effects of telerehabilitation-based motor imagery training in patients with non-specific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

October 8, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

September 8, 2021

Last Update Submit

July 18, 2025

Conditions

Keywords

non-specific low back paintelerehabilitationmotor imagery

Outcome Measures

Primary Outcomes (4)

  • Feasibility of the methods - minimum recruitment rate

    A minimum recruitment rate of 10 participants per month will be accepted as feasiable.

    through Study Completion, an Average of 10 Months

  • Feasibility of the methods - minimum retention rate

    A target retention rate of 80% will be accepted as feasiable

    through Study Completion, an Average of 10 Months

  • Feasibility of the methods - minimum adherence rate

    A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasiable.

    through Study Completion, an Average of 10 Months

  • Feasibility of the methods - adverse events

    A record sheet was prepared for possible adverse events during the tests and intervention. It includes information about seriousness, expectedness, severity, causality, time, duration of the event and clinical action taken. The numbers of adverse events will be reported

    through Study Completion, an Average of 10 Months

Secondary Outcomes (10)

  • Kinesthetic and Visual Imagery Questionnaire

    Change from Baseline at 10 Weeks

  • Movement Imagery Questionnaire-Revised

    Change from Baseline at 10 Weeks

  • Oswestry Disability Questionnaire,

    Change from Baseline at 10 Weeks

  • International Physical Activity Questionnaire

    Change from Baseline at 10 Weeks

  • VISUAL ANALOGUE SCALE

    Change from Baseline at 10 Weeks

  • +5 more secondary outcomes

Study Arms (3)

Telerehabilitation-based motor imagery group

EXPERIMENTAL

Behavioral: Telerehabilitation-based motor imagery group Participants in the Telerehabilitation-based motor imagery group will imagine for the lumbar region exercises (e.g. bridges, knee-to-chest stretches, pelvic tilts) in the sessions in home using the study audio-video motor imagery script for 2 times per week; 30 min per day for 10 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). In addition, the participants will be given stabilization exercises In addition, the participants will be given stabilization exercises for 10 weeks for 40 minutes, 2 days a week.

Behavioral: Telerehabilitation-based motor imagery trainingBehavioral: Stabilization exercises group

Stabilization Exercises group

ACTIVE COMPARATOR

Behavioral: Stabilization Exercises group An exercise program consisting of lumbar stabilization exercises for the participants will be planned for the pelvic ring muscles to develop the neutral lumbar spine. Co-contraction of the transversus abdominus muscle and the multifidus muscle will form the basis of the exercises. Stabilization exercises will be given for 10 weeks for 40 minutes, 2 days a week.

Behavioral: Stabilization exercises group

Healthy control group

NO INTERVENTION

no specific intervention

Interventions

10 weeks of motor imagery training and stabilization exercises.

Telerehabilitation-based motor imagery group

10 weeks of stabilization exercises.

Stabilization Exercises groupTelerehabilitation-based motor imagery group

Eligibility Criteria

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

You may qualify if:

  • Those who can read and write
  • Patients who have not undergone surgery
  • Those with a body mass index less than 30 m2/kg
  • To have sufficient computer knowledge to participate in the study or to have a relative who can help in this regard
  • Having a computer and active internet connection at home

You may not qualify if:

  • Medically uncontrolled and uncooperative patients
  • Patients who have undergone surgery to the lumbar region
  • History of falling in the last 6 months
  • Those with serious orthopedic, vascular, neurological, psychiatric problems affecting balance
  • Active malignancy
  • Pregnancy
  • Having severe vision and hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilge Kara

Izmir, Turkey (Türkiye)

Location

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
Lecturer

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 20, 2021

Study Start

October 8, 2022

Primary Completion

July 15, 2025

Study Completion

July 16, 2025

Last Updated

July 23, 2025

Record last verified: 2024-07

Locations