Low Back Pain, Chronic Low Back Pain, Central Sensitization
Conditions
Keywords
pain neuroscience education, neuromuscular exercise
Brief summary
The goal of this randomized controlled study is to evaluate the effectiveness of pain neuroscience education (PNE) combined with neuromuscular exercises (NME) in individuals with chronic low back pain and central sensitization, and to compare the effects of this combined intervention with NME alone. The main questions it aims to answer are: * Does PNE combined with NME (PNE+NME) affect pain and functional outcomes in individuals with chronic low back pain and central sensitization? * Does NME alone affect pain and functional outcomes in individuals with chronic low back pain and central sensitization? * Does adding PNE to NME affect pain and functional outcomes compared with NME alone? Researchers will evaluate changes in pain and functional outcomes from baseline to post-intervention in both the PNE+NME and NME groups. Changes in outcomes will then be compared between the two groups to determine whether adding PNE to NME affects pain and functional outcomes compared with NME alone. Participants will: * Be randomly assigned to either the PNE+NME group or the NME group. * Participate in the assigned intervention for 8 weeks, with 2 sessions per week. * Complete outcome assessments at baseline and after the 8-week intervention.
Detailed description
Chronic low back pain (CLBP) is a common musculoskeletal condition that can lead to persistent pain, poor functional and psychosocial outcomes. Central sensitization (CS) is present in a subgroup of individuals with CLBP and may contribute to poorer outcomes and greater clinical complexity. Pain neuroscience education (PNE) aims to improve individuals' understanding of pain mechanisms and modify maladaptive pain-related beliefs. Neuromuscular exercises (NME) aim to improve motor control, muscle function, balance, coordination, and physical function. This study will investigate the effectiveness of pain neuroscience education (PNE) combined with neuromuscular exercises (NME) in individuals with chronic low back pain and central sensitization and compare the effects of this combined intervention with NME alone. After eligibility is confirmed and written informed consent is obtained, participants will be randomly assigned to either the NME group or the PNE+NME group. Both groups will participate in an 8-week exercise program with two sessions per week. The PNE+NME group will receive PNE in addition to NME. At baseline, sociodemographic characteristics, including age, sex, height, weight, body mass index, occupation, medical history, and family history, and health-related habits, including smoking, alcohol consumption, and exercise habits, will be recorded. The following outcomes will be assessed at baseline and after the 8-week intervention: central sensitization using the Central Sensitization Inventory; pain intensity using the Visual Analog Scale; pressure pain threshold using a pressure algometer; conditioned pain modulation; temporal summation; pain neuroscience knowledge using the Pain Neurophysiology Questionnaire; kinesiophobia using the Tampa Scale for Kinesiophobia; pain catastrophizing using the Pain Catastrophizing Scale; patient-reported physical function using the Oswestry Disability Index; performance-based physical function using the 30-Second Sit-to-Stand Test; body awareness using the Fremantle Back Awareness Questionnaire; spinal structure and mobility using the Hocoma-Valedo®Shape; trunk muscle endurance using the McGill protocol; balance using the ProKin 252 (Tecnobody); and sleep quality using the Single-Item Sleep Quality Scale.
Interventions
BEHAVIORALPain Neuroscience Education
Participants will receive pain neuroscience education (PNE) and neuromuscular exercise (NME) twice weekly for 8 weeks. Each session will last approximately 30-40 minutes.
BEHAVIORALNeuromuscular Exercise
Participants will receive neuromuscular exercise (NME) twice weekly for 8 weeks. Each session will last approximately 30-40 minutes.
Sponsors
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 years * Low back pain lasting for at least 3 months * Low back pain as the primary complaint * Central Sensitization Inventory (CSI) score ≥28 * Ability to read and write in Turkish * Willingness to participate in the study
Exclusion criteria
* History of spinal surgery * Presence of serious comorbidities (neurological, neuromuscular, cardiovascular, psychiatric conditions) * Presence of tumoral conditions * Presence of vestibular system disorders * Pregnancy * Having received physiotherapy within the previous 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | From enrollment to the end of intervention at 8 weeks | Pain intensity at rest, during activity, and at night will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central sensitization | From enrollment to the end of intervention at 8 weeks | The Central Sensitization Inventory (CSI) will be used to assess central sensitization symptoms. Part A consists of 25 items scored on a 5-point Likert scale, yielding a total score of 0-100. Higher scores indicate more severe symptoms. |
| Pressure pain threshold | From enrollment to the end of intervention at 8 weeks | Pressure pain threshold (PPT) will be measured using a pressure algometer at the thumbnail of the dominant hand and the L5-S1 intervertebral region. A 1-cm² probe will be applied perpendicular to the skin at a rate of 0.5 kg/s until pain is first perceived. Three measurements will be taken at 30-second intervals at each site, and the mean will be recorded. |
| Conditioned pain modulation | From enrollment to the end of intervention at 8 weeks | Conditioned Pain Modulation (CPM) will be assessed using an ischemic conditioning stimulus induced by cuff inflation to 260 mmHg on the non-dominant arm, combined with wrist exercises using 1 kg for women and 2 kg for men. Exercise will continue for up to 45 repetitions or until arm pain reaches 7 out of 10. PPT will be measured three times at the thumbnail and L5-S1 region before and immediately after conditioning. CPM will be calculated as the difference between post- and pre-conditioning PPT values. |
| Temporal summation | From enrollment to the end of intervention at 8 weeks | Temporal Summation (TS) will be assessed using a pressure algometer with a 1 cm² probe. Ten consecutive pressure stimuli will be applied at the PPT level to the previously tested sites, with 1-second intervals between stimuli. Pain intensity after the first and tenth stimuli will be rated using a 100-mm VAS. The TS score will be calculated as the difference between the tenth and first VAS scores (post-pre). |
| Pain neuroscience knowledge | From enrollment to the end of intervention at 8 weeks | Revised Neurophysiology of Pain Questionnaire (RNPQ) assesses knowledge of pain neurophysiology and consists of 12 items. Correct answers receive 1 point, while incorrect and "undecided" responses receive 0 points. Total scores range from 0 to 12, with higher scores indicating greater knowledge of pain neurophysiology. |
| Kinesiophobia | From enrollment to the end of intervention at 8 weeks | Tampa Scale for Kinesiophobia (TSK) assesses fear of movement and consists of 17 items rated on a 4-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). Items 4, 8, 12, and 16 are reverse-scored before calculating the total score, which ranges from 17 to 68. Higher scores indicate greater kinesiophobia. |
| Pain catastrophizing | From enrollment to the end of intervention at 8 weeks | Pain Catastrophizing Scale (PCS) assesses negative thoughts and feelings related to pain and consists of 13 items rated on a 5-point scale from 0 (not at all) to 4 (all the time). Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing. |
| Body awareness | From enrollment to the end of intervention at 8 weeks | Fremantle Back Awareness Questionnaire (FreBAQ) assesses perceptual body awareness of the lower back and consists of 9 items covering neglect-like symptoms, reduced proprioceptive acuity, and perceived body shape and size. Items are rated on a 5-point Likert scale from 0 (never) to 4 (always), yielding a total score of 0-36. Higher scores indicate greater disturbances in back-specific body awareness. |
| Disability | From enrollment to the end of intervention at 8 weeks | Oswestry Disability Index (ODI) assesses disability related to low back pain and consists of 10 sections. Each section is scored from 0 to 5, yielding a total score of 0-50. The total score may be multiplied by two to express disability as a percentage (0-100%). Higher scores indicate greater disability. |
| Performance-based physical function | From enrollment to the end of intervention at 8 weeks | 30-Second Sit-to-Stand Test (30 s- STS) assesses functional lower-extremity performance. Participants sit in a chair with their feet flat on the floor and arms crossed over the chest. They are instructed to perform as many sit-to-stand repetitions as possible within 30 seconds. The number of completed repetitions is recorded, with higher scores indicating better functional performance. |
| Spinal structure and mobility | From enrollment to the end of intervention at 8 weeks | Spinal posture and mobility will be assessed using the computer-assisted, non-invasive Hocoma-Valedo®Shape device (Idiag, Fehraltorf, Switzerland). Assessments will be performed with participants standing, with the spinous processes from C7 to S3 marked using a pen. Measurements will be obtained in upright standing, maximum trunk flexion, maximum trunk extension, and maximum right and left lateral flexion positions. The device will be moved along the spine from C7 to S3, tracking the marked spinous processes. Thoracic, lumbar, sacral, and inclination angles will be calculated using the device software. Spinal mobility will be calculated as the difference between maximum flexion and extension in the sagittal plane and between maximum right and left lateral flexion in the frontal plane. |
| Trunk muscle endurance | From enrollment to the end of intervention at 8 weeks | Trunk muscle endurance will be assessed using the McGill test battery, consisting of trunk flexor, right and left lateral trunk, and trunk extensor endurance tests. The duration for which each position is maintained will be recorded in seconds, with longer times indicating greater trunk muscle endurance. |
| Balance | From enrollment to the end of intervention at 8 weeks | Balance will be assessed using the ProKin 252 system (Tecnobody, Dalmine, Italy), including static balance with eyes open and closed and limits of stability. Static balance will be assessed over 30 seconds, recording anteroposterior and mediolateral sway (mm) and the balance index (mm²). Limits of stability will be assessed by weight shifting in eight directions, with results expressed as percentages. |
| Sleep quality | From enrollment to the end of intervention at 8 weeks | Sleep quality will be assessed using the Single-Item Sleep Quality Scale, a self-administered visual analog scale ranging from 0 (terrible) to 10 (excellent), evaluating overall sleep quality over the previous seven days. Higher scores indicate better sleep quality. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORDerya Ozer Kaya, PhD, Prof.
Izmir Katip Celebi University
CONTACTSevinc Akdeniz, MSc
Outcome results
None listed