Skip to main content
OpenTrials
Completed

NCT Number: NCT05351008

Effects of CFT in Individuals With CNLBP

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Back Pain Low Back Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Low Back Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Clinic Trevlakis Emmanouil

Thessaloniki, 54635, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Functional Therapy

Other

A physicaltheapy approach combining cognitive techniques, func-tional movement training, functional integration and Lifestyle Changes.

Exercise program:

Other

Core strengthening program

Primary outcomes

  1. Pain intensity

    Time frame: through study completion, an average of 2 year

    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.

  2. Disability

    Time frame: through study completion, an average of 2 years

    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.

Secondary outcomes

  1. Fear-Avoidance Beliefs

    Time frame: through study completion, an average of 2 years

    Fear-Avoidance Beliefs Questionnaire (FABQ)

  2. Anxiety

    Time frame: through study completion, an average of 2 years

    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.

  3. Depression

    Time frame: through study completion, an average of 2 years

    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.

  4. 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.

    Time frame: through study completion, an average of 2 years

    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.

Sponsors and collaborators

Lead sponsor

International Hellenic University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.