Clinical trial NCT05928975: Manual Therapy Plus Pain Neuroscience Education With Integrated Motivational Interviewing in Individuals With Non-Specific Chronic Low Back Pain
Official title: Effects of Manual Therapy Plus Pain Neuroscience Education With Integrated Motivational Interviewing on Pain, Disability, Kinesiophobia and Catastrophizing in Individuals With Non-Specific Chronic Low Back Pain: A Randomized Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Chronic Low Back Pain
Keywords: Non-specific Chronic Low Back pain
Manual therapy
Pain neuroscience education
Motivational Interviewing
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Duration of symptoms at least 12 weeks
* Reported pain intensity of 3 or greater according to the numeric pain rating scale (NPRS)
* Written consent to participate in the study

Exclusion Criteria:

* Neuropathic pain extending along the lower limb due to nerve root compression
* Previous spine surgery
* History of spine trauma or fracture
* Cancer
* Severe osteoporosis
* Spondylo-arthropathy
* Spondylolisthesis
* Systemic inflammatory disease
* Illiterate individuals
* Diagnosed neurodegenerative diseases (e.g., Parkinson's)
* Epilepsy
* History of psychiatric disorders

Primary outcomes:
measure: Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS)
timeFrame: pre-intervention, 4th week, 6-month follow-up
measure: Changes in Pressure Pain Threshold (PPT) with pressure algometry
timeFrame: pre-intervention, 4th week, 6-month follow-up
measure: Changes in functional capacity with the Greek Version of Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: pre-intervention, 4th week, 6-month follow-up
measure: Changes in Kinesiophobia with Tampa Scale for Kinesiophobia (TSK)
timeFrame: pre-intervention, 4th week, 6-month follow-up
measure: Changes in Fear- Avoidance behaviour with Fear- Avoidance Beliefs Questionnaire (FABQ)
timeFrame: pre-intervention, 4th week, 6-month follow-up
measure: Changes in Catastrophizing with Pain-Catastrophizing-Scale (PCS)
timeFrame: pre-intervention, 4th week, 6-month follow-up
measure: Changes in Performance was assessed using the Back Performance Scale (BPS)
timeFrame: pre-intervention, 4th week, 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
state: Sindos Thessaloníki, Greece
Study officials:
References: