Manual Therapy Plus Pain Neuroscience Education With Integrated Motivational Interviewing in Individuals With Non-Specific Chronic Low Back Pain
Condition: Non-specific Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific chronic low back pain (NSCLBP) is characterized by persistent back pain that
      lasts longer than 12 weeks. This clinical trial aims to examine the short-term and long-term
      effects of adding Pain Neuroscience Education (PNE) with integrated Motivational Interviewing
      (MI) to a Manual Therapy (MT) program on pain intensity, pressure pain threshold (PPT), back
      performance, disability, kinesiophobia, fear and avoidance, and catastrophizing in
      individuals suffering from NSCLBP. The study adopts a randomized, controlled, single-blind
      design, with a total of 60 participants randomly allocated to three groups. The first group
      will receive MT and PNE with MI, the second group will receive MT alone, and the control
      group (third group) will follow a home-based exercise program only. All interventions will
      last for 4 weeks. Outcome measures will be assessed at three time points: pre-intervention,
      at 4 weeks, and at 6 months. The statistical analysis of the results will use a two-factor
      analysis of variance with repeated measurements, and the statistical significance index will
      be set at p < 0.05.
    

Detailed description: 
      Background: Non-specific chronic low back pain (NSCLBP) is characterized by persistent back
      pain that lasts longer than 12 weeks. Manual therapy (MT) is likely to exhibit short-term
      efficacy for NSCLBP and is recommended by clinical guidelines. Pain Neuroscience Education
      (PNE) is a method through which patients are taught how to alter their own pain perception
      using explanations, metaphors, and examples, aiming to reduce the perception of painful
      stimuli at the central nervous system level. Integrated Motivational Interviewing (MI)
      consists of a patient-centered communication approach that aims to elicit and enhance
      motivation for behavior change, guiding patients away from ambivalence and uncertainty.

      Aim: To study the effects of adding PNE with MI to an MT program on pain, pressure pain
      threshold (PPT), disability, kinesiophobia, catastrophizing, fear and avoidance, and back
      performance in individuals suffering from NSCLBP..

      Method: Sixty adults with NSCLBP will be randomly assigned into three groups of 20 people
      each. The first group will receive MT and PNE with integrated MI. The second group will
      follow MT without PNE with integrated MI. The third group (control) will receive a
      conventional home-based exercise program. Pain in the last 24 hours with the Numeric Pain
      Rating Scale (NPRS), functional ability with the Roland- Morris Disability Questionnaire
      (RMDQ), PPT in the lumbar region through pressure algometry, kinesiophobia with Tampa Scale
      for Kinesiophobia (TSK), Fear- Avoidance behavior with Fear- Avoidance Beliefs Questionnaire
      (FABQ), catastrophizing with Pain-Catastrophizing-Scale (PCS) and performance using the Back
      Performance Scale (BPS) will be evaluated at baseline, at the 4th week, and six months
      post-intervention..

      Expected results: Manual therapy in combination with Pain Neuroscience Education have shown
      short term positive effects on pain, kinesiophobia and catastrophizing in individuals with
      non-specific low back pain. Combining Manual Therapy with Pain Neuroscience Education with
      integrated MI holds promise for achieving improved outcomes characterized by larger and
      longer-lasting effects.
    

Intervention name(s): MT+ PNE with MI; MT; Control
Intervention type(s): Other; Other; Other
Intervention description(s): The manual therapy treatment approach entailed the management of symptoms based on the clinical judgment of the attending physiotherapist. The physiotherapist selectively employed techniques such as spinal mobilization/manipulation, soft tissue massage, supervised exercises and muscle and neural mobilization, while excluding the utilization of electrophysical modalities. The participants will receive 10 Manual Therapy sessions of 30 minutes within a period of 4 weeks.
The pain neuroscience education program is based on previous clinical studies and available educational materials and is enhanced by motivational interviewing techniques. The program consisted of 4 individualized educational sessions, each lasting 30 minutes. All key aspects of pain neurophysiology were explained and discussed. At the end of the first session, participants will be provided with informational handouts to support the educational process.; Participants in this group will be given the same MT program as "MT + PNE with MI group" without the application of PNE.; The participants in the control group will be provided with written instructions for performing general exercises at home. These exercises will consist of gentle stretching exercises specifically targeting the low back muscles, as well as relief positions and breathing relaxation exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty participants with non-specific chronic low back pain will be randomly assigned to three groups of 20 each. The allocation of the sample to the groups will be performed using a randomization program (https://www.randomizer.org/) by an independent researcher. The first group will receive MT and PNE with MI, the second group will receive MT alone, while participants in the control group (third group) will follow a home-based exercise program. Participants of the two intervention groups will follow a total of 10 treatment sessions over a period of 4 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-specific Chronic Low Back pain; Manual therapy; Pain neuroscience education; Motivational Interviewing