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Pain Neuroscience Education and Neuromuscular Exercise in Individuals With Chronic Low Back Pain and Central Sensitization

ConditionsLow Back PainChronic Low Back PainCentral Sensitization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIzmir Katip Celebi University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of spinal surgery

Presence of serious comorbidities (neurological, neuromuscular, cardiovascular, psychiatric conditions)

Presence of tumoral conditions

Presence of vestibular system disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pain Neuroscience Education

    Behavioral

    Participants will receive pain neuroscience education (PNE) and neuromuscular exercise (NME) twice weekly for 8 weeks. Each session will last approximately 30-40 minutes.

  • Neuromuscular Exercise

    Behavioral

    Participants will receive neuromuscular exercise (NME) twice weekly for 8 weeks. Each session will last approximately 30-40 minutes.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: PNE+NMEExperimental treatment 2 interventions
Group B: NMEActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

Visual Analog Scale (VAS)

Time frame
At baseline and after the 8-week intervention

Secondary outcomes

1

Central sensitization

Central Sensitization Inventory (CSI)

Time frame
At baseline and after the 8-week intervention
2

Pressure pain threshold

Pressure algometer

Time frame
At baseline and after the 8-week intervention
3

Conditioned pain modulation

Conditioned pain modulation will be assessed using pressure pain thresholds before and after ischemic conditioning with an upper-arm cuff.

Time frame
At baseline and after the 8-week intervention
4

Temporal summation

Temporal summation will be assessed using repeated pressure stimuli delivered with a pressure algometer. Pain intensity after the first and tenth stimuli will be recorded using the Visual Analog Scale (VAS).

Time frame
At baseline and after the 8-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Izmir Katip Celebi University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: