Effects of CFT in Individuals With CNLBP

Effects of Cognitive Functional Therapy in Individuals With Chronic Neuropathic Low Back Pain

This research aims to deepen the understanding of the interplay between chronic neuropathic low back pain and its effects on physical health, mental well-being, and overall quality of life. Additionally, it will evaluate the impact of cognitive functional therapy (CFT) and core strengthening programs on managing chronic neuropathic low back pain. The study is grounded in the hypothesis that CFT will offer a comprehensive, multidisciplinary, and holistic therapeutic approach for individuals suffering from chronic neuropathic low back pain.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neuropathic Low Back Pain
• Intervention / Treatment: Other: Cognitive Functional Therapy; Other: Exercise program:

Detailed Description

In July 2020, the International Association for the Study of Pain (IASP) revised the definition of pain, according to which pain is an unpleasant aesthetic and emotional experience related to, or appears to be related to, real or potential tissue damage. Chronic pain is characterized by a long duration, exceeding 6 months. Chronic neuropathic pain is caused by damage or disease of the somatosensory nervous system.

Cognitive Functional Therapy (CFT) is a multidimensional, patient-centred intervention that directly explores and manages cognitive, psychological and social factors deemed to be barriers to recovery in chronic low back pain (Vibe Fersum K et al., 2013; Meziat Filho, 2015; Meziat Filho et al., 2016; O'Keeffe et al., 2015a; Rabey et al., 2015; Meziat-Filho et al., 2018). The CFT approach centres on the retraining of maladaptive movement patterns, reconceptualising patient pain beliefs, and addressing any relevant cognitive, psychological, social or lifestyle factors (O'Sullivan P., 2005). CFT is an integrated behavioral approach for individualizing the management of people with disabling LBP once serious (eg, malignancy, infection, inflammatory disorder, and fracture) and specific pathology (eg, nerve root compression with progressive neurological deficit with or without cauda equina symptoms) has been excluded (O'Sullivan et al., 2018).

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki
    • Thessaloníki, Thessaloniki, Greece, 54635
      • Physical Therapy Clinic Trevlakis Emmanouil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Eligible participants were

• adults (aged ≥18 years) with chronic (≥ 3 months) low back pain prior to surgery,
• who consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.

Exclusion criteria were

• serious spinal pathology (eg, fracture, infection, or cancer),
• any medical condition that prevented being physically active,
• being pregnant or having given birth within the previous year,
• inadequate Greek literacy for the study's questionnaires and instructions,
• surgery scheduled within 4 months,
• BMI greater than 40 kg/m2,
• history of psychogenic illness or manic episode,
• history of other neuromuscular disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Functional Therapy group; The group will receive 4 months 1 times per week of cognitive functional therapy.	Other: Cognitive Functional Therapy; A physicaltheapy approach combining cognitive techniques, func-tional movement training, functional integration and Lifestyle Changes.
Active Comparator: Core strengthening group; The group will receive 4 months 1 times per week of an exercise program aming core strengthening.	Other: Exercise program: Core strengthening program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Short-form McGill Pain Questionnaire (SF-MPQ) is a pain rating index with 2 scales: Sensory subscale with 11 words, and Affective subscale with 4 words from the original MPQ. Minimum value 0, maximum value 5.	through study completion, an average of 2 year
Disability	Roland-Morris Disability Questionnaire (RDQ), is a 24-item patient-reported outcome measure that inquiries about pain-related disability resulting from low back pain (LBP). The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Generalised Anxiety Disorder Assessment (GAD-7) is a 7-item, self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD). A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety on the GAD-7.	through study completion, an average of 2 years
Depression	Patient Health Questionnaire-9 (PHQ-9) is a 9-item, self-administered screening instrument for detecting MDD based on the DSM-IV diagnostic criteria. A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.	through study completion, an average of 2 years
Quality of Life as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.	WHO Quality of life - bref is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, or alternatively, a 4-20 point interval.	through study completion, an average of 2 years
Fear-Avoidance Beliefs	Fear-Avoidance Beliefs Questionnaire (FABQ)	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: International Hellenic University
• Investigators: Study Chair: Alexandra-Hristara Papadopoulou, Professor, International Hellenic University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Low back pain; Chronic pain; Neuropathic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: IntHellenicUniv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Risk of bias To control for expectation bias, participants were told that the study was being performed to compare two interventions for CLBP, and that based on current knowledge, it was not known which intervention was superior.

Randomization and masking Simple randomization was used. Sealed opaque envelopes were sent by the research team to each site. Allocation was picked by each participant from a sealed opaque envelope, given by the consulting physiotherapist, after eligibility for the study was established, to ensure concealed allocation. The envelope contained only two pieces of paper. Participants were asked to pick one piece of paper from the envelope. One piece of paper had the letter 'C' for CFT and the other, letter 'T' for traditional physical therapy. Participants and physiotherapists could obviously not be masked to randomization because the physiotherapists were administering the active intervention.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No