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

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.

Conditions

• Non-specific Chronic Low Back Pain

Interventions

OTHER

MT+ PNE with MI

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.

OTHER

MT

Participants in this group will be given the same MT program as "MT + PNE with MI group" without the application of PNE.

OTHER

Control

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.

Sponsors & Collaborators

• International Hellenic University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-05

Primary Completion

2023-09-15

Completion

2023-09-15

Countries

• Greece

Study Locations