NCT07674407

Brief Summary

Lumbar disc herniation is one of the most common causes of low back pain and is associated with substantial functional limitations and reduced quality of life, particularly among working-age individuals. Displacement of disc material toward the spinal canal may result in mechanical compression and inflammation of the nerve roots, leading to pain, restricted movement, and reduced functional performance. The course of low back pain cannot be explained solely by biomechanical and anatomical factors. Psychosocial factors also play an important role in symptom persistence and functional outcomes. Within this context, the fear-avoidance model provides an important theoretical framework, suggesting that individuals may develop fear of movement and avoid physical activities because they believe these activities may increase pain or cause further injury. Over time, avoidance behaviors may contribute to physical deconditioning, reduced muscle function, and increased functional impairment. The Fear-Avoidance Beliefs Questionnaire is commonly used to assess individuals' beliefs regarding the relationship between pain, physical activity, and work-related activities. Higher levels of fear-avoidance beliefs have been associated with greater pain severity, increased disability, and poorer physical performance in individuals with low back pain. Trunk muscle endurance plays a key role in maintaining spinal stability. Adequate endurance of the paraspinal and abdominal muscles supports mechanical stability of the spine and contributes to the safe performance of functional movements. The Biering-Sørensen Test and plank test are commonly used to assess trunk muscle endurance in clinical and research settings. The Biering-Sørensen Test evaluates the endurance of the trunk extensor muscles, whereas plank-based tests assess the endurance of the anterior and lateral trunk musculature. Functional impairment in individuals with low back pain can be evaluated using the Oswestry Disability Index, a self-reported questionnaire that assesses limitations experienced during activities of daily living. Functional mobility and performance may also be evaluated using the Timed Up and Go test, which involves standing up from a chair, walking a short distance, turning, returning to the chair, and sitting down. This test reflects mobility, dynamic balance, and functional performance during daily activities. Postural control and balance may also be affected in individuals with low back pain. Reduced static balance performance can negatively influence functional activities and mobility. The Single-Leg Stance Test is a practical clinical measure used to assess postural stability and static balance. Although previous studies have examined associations between psychosocial factors and functional status in individuals with low back pain, studies evaluating the relationship between fear-avoidance beliefs, trunk muscle endurance, balance, and functional performance together remain limited. Identifying these relationships may contribute to the development of more comprehensive rehabilitation programs for individuals with lumbar disc herniation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress27%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

fear-avoidance beliefstrunk muscle endurancebalancefunctional impairmentlow back pain

Outcome Measures

Primary Outcomes (6)

  • Fear-Avoidance Beliefs

    Fear-avoidance beliefs related to pain will be assessed using the Fear-Avoidance Beliefs Questionnaire. The Fear-Avoidance Beliefs Questionnaire is a self-reported questionnaire that evaluates individuals' fear-avoidance beliefs regarding pain in relation to physical activity and work-related activities. The questionnaire consists of 16 items and includes two subscales: the Physical Activity subscale and the Work subscale. Participants rate each statement on a Likert-type scale ranging from 0 (completely disagree) to 6 (completely agree). Higher scores indicate stronger fear-avoidance beliefs, suggesting greater concern that physical activity or work-related activities may worsen pain or cause further injury. Lower scores indicate fewer fear-avoidance beliefs and less perceived threat associated with movement and activity.

    4 weeks

  • Lumbar Extensor Muscle Endurance

    Lumbar extensor muscle endurance will be assessed using the Biering-Sørensen Test. During the test, participants will be positioned prone on a treatment table, with the pelvis and lower extremities stabilized. Participants will be instructed to maintain their upper body in a horizontal position with the trunk extending beyond the edge of the table. The duration for which the participant maintains this position will be recorded in seconds using a stopwatch. The test will be terminated if the participant is unable to maintain the required position, demonstrates a loss of alignment, or wishes to stop the test. A longer holding time indicates greater lumbar extensor muscle endurance, whereas a shorter holding time indicates reduced lumbar extensor muscle endurance.

    4 weeks

  • Abdominal Muscle Endurance

    Abdominal muscle endurance will be assessed using the plank test. Participants will assume a prone plank position with the elbows positioned under the shoulders and the toes in contact with the floor. They will be instructed to maintain the trunk in a straight line. The duration for which the position is maintained will be recorded in seconds using a stopwatch. The test will be terminated if trunk alignment is lost or if the participant is unable to continue. A longer holding time indicates greater abdominal muscle endurance and trunk stabilization capacity, whereas a shorter holding time indicates reduced abdominal muscle endurance.

    4 weeks

  • Assessment of Functional Impairment

    Functional impairment in activities of daily living will be assessed using the Oswestry Disability Index. The Oswestry Disability Index is a self-reported questionnaire that evaluates the impact of low back pain on daily activities. It consists of 10 sections, each containing six response options that reflect the individual's functional status during daily activities. Each section is scored from 0 to 5, and the total score is calculated as a percentage. Higher Oswestry Disability Index scores indicate greater functional impairment and disability related to low back pain, whereas lower scores indicate less functional impairment and better functional status.

    4 weeks

  • Assessment of Functional Performance

    Functional mobility and performance will be assessed using the Timed Up and Go test. Participants will begin in a seated position in a standard chair. Upon instruction, participants will stand up, walk three meters to a designated point, turn around, walk back to the chair, and sit down. The completion time will be measured in seconds using a stopwatch. A shorter completion time indicates better functional mobility, dynamic balance, and walking performance, whereas a longer completion time indicates reduced functional mobility and performance.

    4 weeks

  • Assessment of Balance Performance

    Static balance performance will be assessed using the Single-Leg Stance Test. Participants will be instructed to stand on one leg with their arms positioned alongside the body. The duration for which they are able to maintain balance while keeping the opposite foot off the floor will be recorded in seconds using a stopwatch. The test will be terminated if the raised foot touches the floor, the stance foot changes position, or balance is lost. The test may be performed on both the right and left legs, and the holding times will be recorded separately. A longer standing time indicates better static balance and postural stability, whereas a shorter standing time indicates reduced static balance performance.

    4 weeks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include volunteer individuals aged 18-65 who applied to a physiotherapy and rehabilitation clinic and were diagnosed with lumbar disc herniation.

You may qualify if:

  • Aged between 18 and 65 years
  • Clinically and/or radiologically diagnosed with lumbar disc herniation
  • Presence of low back pain for at least 3 months
  • Sufficient cognitive capacity to understand and perform the assessment procedures
  • Ability to walk independently
  • Willingness to participate voluntarily and provide written informed consent

You may not qualify if:

  • History of lumbar spine surgery
  • History of neurological disorders, such as stroke or Parkinson's disease
  • Vestibular disorders or severe balance impairment
  • History of orthopedic injury or surgery affecting the lower extremities
  • Presence of rheumatological disease
  • Pregnancy
  • Severe pain or an acute inflammatory condition that prevents completion of the assessment procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DisplacementLow Back Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations