Effects of Cognitive Functional Therapy in Individuals With Chronic Neuropathic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Pain intensity
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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.
Arms & Interventions
Cognitive Functional Therapy group
The group will receive 4 months 1 times per week of cognitive functional therapy.
Intervention: Cognitive Functional Therapy (Other)
Core strengthening group
The group will receive 4 months 1 times per week of an exercise program aming core strengthening.
Intervention: Exercise program: (Other)
Outcomes
Primary Outcomes
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.
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
- 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.(through study completion, an average of 2 years)
- Depression(through study completion, an average of 2 years)
- Fear-Avoidance Beliefs(through study completion, an average of 2 years)
- Anxiety(through study completion, an average of 2 years)
Investigators
Evgenia Trevlaki
Principal Investigator
International Hellenic University