Clinical trial NCT05351008: Effects of CFT in Individuals With CNLBP
Official title: Effects of Cognitive Functional Therapy in Individuals With Chronic Neuropathic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Neuropathic Low Back Pain
Keywords: Chronic pain
Neuropathic pain
Low back pain
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms, parallel-design, assessor-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: through study completion, an average of 2 year
measure: Disability
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Fear-Avoidance Beliefs
timeFrame: through study completion, an average of 2 years
measure: Anxiety
timeFrame: through study completion, an average of 2 years
measure: Depression
timeFrame: through study completion, an average of 2 years
measure: 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.
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Physical Therapy Clinic Trevlakis Emmanouil
state: Thessaloniki
Study officials:
affiliation: International Hellenic University
name: Alexandra-Hristara Papadopoulou, Professor
role: STUDY_CHAIR
References: