ClinicalTrials.Veeva

Menu

Manual Therapy Plus Pain Neuroscience Education With Integrated Motivational Interviewing in Individuals With Non-Specific Chronic Low Back Pain

I

International Hellenic University

Status

Completed

Conditions

Non-specific Chronic Low Back Pain

Treatments

Other: MT
Other: Control
Other: MT+ PNE with MI

Study type

Interventional

Funder types

Other

Identifiers

NCT05928975
EC-08/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

MT+ PNE with MI
Experimental group
Description:
Participants allocated to this group will receive 10 sessions of MT, along with 4 sessions of PNE with MI, over a period of four weeks.
Treatment:
Other: MT+ PNE with MI
MT
Experimental group
Description:
Participants allocated to this group will receive 10 sessions of MT (without PNE with MI), over a period of four weeks.
Treatment:
Other: MT
Control
Active Comparator group
Description:
Participants allocated to this group will engage in a home-based general exercise program.
Treatment:
Other: Control

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems