NCT07237724

Brief Summary

Non-specific low back pain (NSLBP) is one of the most common musculoskeletal disorders all over the world and a leading cause of disability. It affects individuals across different age groups and is typically characterized by pain, stiffness, and functional limitations that reduce physical activity and overall quality of life. Among established clinical approaches, Core exercises are frequently used in the management of LBP, reducing pain and improving functionality by stabilizing the spine. However, despite their widespread use, there is limited evidence on the effectiveness of combining core exercises with cognitive interventions, such as action observation. Motor imagery (MI) and action observation (AO) offer practical, low-cost approaches that can be easily integrated into rehabilitation programs. Motor imagery involves the individual visualizing the physical movement in their mind without performing it, while action observation involves learning specific movements by observing them. These techniques can strengthen the effectiveness of physical exercises by increasing neuromuscular activation. However, it has been reported that motor imagery-based cortical processes facilitate the reorganization of sensory-motor functions during daily activities in LBP patients. Studies in this area are quite limited. The effectiveness of action observation therapy, which is primarily effective in neurological conditions, has not been investigated in non-specific low back pain. Therefore, in this study, the effects of combining action observation therapy with a core exercise program, Pain, Function, Endurance, Kinesiophobia, and Sleep Quality in patients with non-specific low back pain will be examined. The study aims to investigate the effects of combining action observation therapy with core exercises compared with core exercises alone in patients with NSLBP. Patients attending Fizyowell physiotherapy and Healthy Services clinic who meet the inclusion criteria will be included in the study. This study seeks to explore the potential benefits of integrating cognitive techniques into a conventional exercise-based rehabilitation for NSLBP. To establish participant eligibility before the study begins, a standardized demographic data form will be collected from all subjects who volunteered to participate in the study, including gender, age, height, weight, education, marital status, chronic diseases and medication use, smoking, and alcohol use. In addition, the Mini-Mental State Examination (MMSE) will be used to assess the patient's mental state, determine the ability to understand and follow instructions, and identify cognitive disorders that may make it difficult to perform mental interventions. The Movement Imagery Questionnaire-3 (MIQ-3) will be used to determine each participant's motor imagery ability. Once eligibility is confirmed, baseline assessments will be conducted, including pain intensity measured by the Visual Analog Scale (VAS), functional disability assessed using the Oswestry Low Back Pain Disability Index Questionnaire, kinesiophobia evaluated with the Tampa Scale for Kinesiophobia (TSK), core endurance tested through standardized endurance measures, and sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). After the initial evaluation, the treatment program will be started. Advances in the treatment method specific to the groups they belong to are explained in detail below. Treatment: After the first evaluation, the core exercise program will be applied to the patients in Group 1, 3 days per week for 6 weeks. All sessions will be conducted under the supervision of a physiotherapist at the clinic. Group 2: Conservative Treatment + Action Observation Program. This group will have action observation therapy in addition to the core exercise program. The patients in this group will receive an action observation therapy for 6 minutes before each exercise therapy session. They will watch videos of 2 different activities, the duration of each video is 3 minutes, and they were recorded from 3 planes (frontal, back, and lateral).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 14, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

action observationNon-specific Low Back Paincore exercises

Outcome Measures

Primary Outcomes (1)

  • Pain Level

    The Visual Analog Scale (VAS) is an important instrument used for measuring the severity of low back pain at rest and during physical activity. It provides a simple, validated method of transforming subjective pain experiences into numerical values suitable for statistical analysis. Participants will be asked to rate their pain intensity on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "unbearably severe pain".

    Baseline (Day 1) and After 6 Weeks of Treatment

Secondary Outcomes (4)

  • Functionality Level

    Baseline (Day 1) and Week 6.

  • Core Muscle Endurance

    At baseline and after 6 weeks of intervention

  • Kinesiofobia Level

    Baseline and Week 6.

  • Sleep Quality

    From the start of treatment until 6 week after the end of treatment

Study Arms (2)

Core Exercise Program

ACTIVE COMPARATOR

Participants receive supervised core exercise therapy 3 times per week for 6 weeks.

Other: Core Exercise Program

Core Exercise + Action Observation

EXPERIMENTAL

Participants receive the same core exercise therapy plus an action observation session before each treatment.

Other: Action Observation Therapy

Interventions

* The patients will do their exercises at the clinic as face to face sessions. All sessions will be conducted under the supervision of a physiotherapist * patients will receive core exercises program, 3 days per week * Treatment duration is 6 weeks

Core Exercise Program

* The patients will do their exercises at the clinic as face to face sessions. All sessions will be conducted under the supervision of a physiotherapist * patients will receive the same core exercises program as the Active comparator group, 3 days per week for 6 weeks * This group will receive action observation therapy for 6 minutes before every exercise therapy session. they will watch videos of 2 different activates, the duration of each video is 3 minutes and will be recorded from 3 planes (front, back and lateral )

Core Exercise + Action Observation

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older,
  • Being a volunteer.
  • Having nonspecific chronic low back pain for three months or more.
  • No obvious structural or anatomical abnormality that could explain the pain.
  • Scoring 24 or more out of 30 on the Mini-Mental State Examination.
  • Those who score high in terms of imagery ability on the MIQ-3 questionnaire.
  • Not having any pathology in vision or hearing

You may not qualify if:

  • pregnancy
  • Having a painful spinal deformity.
  • Having a spinal surgery
  • Having a mental illness and/or communication problem.
  • Having pain radiating to the lower extremity.
  • Having any back disease diagnosed by a specialist physician other than non-specific chronic back pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Hamdi Shalabi

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Salik Sengul Y, Kaya N, Yalcinkaya G, Kirmizi M, Kalemci O. The effects of the addition of motor imagery to home exercises on pain, disability and psychosocial parameters in patients undergoing lumbar spinal surgery: A randomized controlled trial. Explore (NY). 2021 Jul-Aug;17(4):334-339. doi: 10.1016/j.explore.2020.02.001. Epub 2020 Feb 22.

  • Ozturk O, Bombaci H, Kececi T, Algun ZC. Effects of additional action observation to an exercise program in patients with chronic pain due to knee osteoarthritis: A randomized-controlled trial. Musculoskelet Sci Pract. 2021 Apr;52:102334. doi: 10.1016/j.msksp.2021.102334. Epub 2021 Jan 24.

  • Salik Sengul Y, Yilmaz A, Kirmizi M, Kahraman T, Kalemci O. Effects of stabilization exercises on disability, pain, and core stability in patients with non-specific low back pain: A randomized controlled trial. Work. 2021;70(1):99-107. doi: 10.3233/WOR-213557.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 20, 2025

Study Start

November 20, 2025

Primary Completion

January 16, 2026

Study Completion

January 16, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy considerations and restrictions imposed by the ethics committee

Locations