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

NCT05928975 | Completed

• 1 other identifier: EC-08/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-specific Chronic Low Back Pain

Keywords

Non-specific Chronic Low Back pain; Manual therapy; Pain neuroscience education; Motivational Interviewing

Outcome Measures

Primary Outcomes (7)

• Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS)

  This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain. The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.

  pre-intervention, 4th week, 6-month follow-up

• Changes in Pressure Pain Threshold (PPT) with pressure algometry

  Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the quadratus lumborum muscle, in the sacroiliac joints, and paravertebrally in the L4-L5 intervertebral space. The metal rod of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure at a rate of 1Kg/s. PPT is calculated in kg/cm2 (Imamura et al., 2016).

  pre-intervention, 4th week, 6-month follow-up

• Changes in functional capacity with the Greek Version of Roland-Morris Disability Questionnaire (RMDQ)

  The functional ability of the participants will be evaluated with the Greek version of the Roland-Morris questionnaire, which consists of 24 questions related to daily activities that patients often report difficulty performing due to low back pain. Each positive answer earns one point and the final score is calculated by adding all the points. Therefore, the higher the score, the greater the restriction. The Greek version of the questionnaire shows satisfactory reliability and validity (ICC: 0.44-0.92) (Boscainos et al., 2003).

  pre-intervention, 4th week, 6-month follow-up

• Changes in Kinesiophobia with Tampa Scale for Kinesiophobia (TSK)

  The assessment of kinesiophobia will be conducted using the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire specifically designed to evaluate fear of movement and re-injury. This scale incorporates parameters related to injury and re-injury, as well as fear-avoidance behaviors in work-related activities. Participants rate each item on a 4-point Likert-type scale, ranging from 1 (definitely disagree) to 4 (completely agree). The total score on the TSK falls within the range of 17 to 68 points, with higher scores indicating a greater level of kinesiophobia. The minimal clinically important difference (MCID) for the TSK is reported to be 8 points.

  pre-intervention, 4th week, 6-month follow-up

• Changes in Fear- Avoidance behaviour with Fear- Avoidance Beliefs Questionnaire (FABQ)

  The Fear-Avoidance Beliefs Questionnaire (FABQ) is a widely used assessment tool designed to measure individuals' beliefs about how physical activity and work-related activities may impact their pain and disability. It consists of fourteen items, which are scored on a 7-point Likert-type scale, ranging from "completely disagree" to "completely agree." The total score ranges from 0 to 96, with higher scores indicating stronger fear-avoidance beliefs.

  pre-intervention, 4th week, 6-month follow-up

• Changes in Catastrophizing with Pain-Catastrophizing-Scale (PCS)

  The Pain Catastrophizing Scale (PCS) is a widely utilized self-report questionnaire designed to assess the extent to which individuals engage in catastrophic thinking when experiencing pain. The PCS consists of 13 items, each describing different thoughts and feelings that individuals may experience when in pain. Participants rate the extent to which they experience each statement on a 5-point Likert-type scale, ranging from "not at all" to "all the time." The scale encompasses three main dimensions of catastrophizing: rumination, magnification, and helplessness.

  pre-intervention, 4th week, 6-month follow-up

• Changes in Performance was assessed using the Back Performance Scale (BPS)

  Performance will be assessed using the Back Performance Scale (BPS) described by Strand, Moe-Nilssen, and Ljunggren (2002). The BPS includes 5 tests of trunk mobility (sock test, pick-up test, roll-up test, fingertip-to-floor test, and lift test). Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points. High score indicates poor performance.

  pre-intervention, 4th week, 6-month follow-up

Study Arms (3)

MT+ PNE with MI

EXPERIMENTAL

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.

Other: MT+ PNE with MI

MT

EXPERIMENTAL

Participants allocated to this group will receive 10 sessions of MT (without PNE with MI), over a period of four weeks.

Other: MT

Control

ACTIVE COMPARATOR

Participants allocated to this group will engage in a home-based general exercise program.

Other: Control

Interventions

MT+ PNE with MI OTHER

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.

MT+ PNE with MI

MT OTHER

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

MT

Control OTHER

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.

Control

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit

Thessaloniki, Sindos Thessaloníki, Greece, 57400, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A masked assessor will conduct the measurements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dimitrios Lytras, Principal Investigator, Senior Lecturer of Physiotherapy

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: January 5, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)