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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Functional Therapy group | Experimental | The group will receive 4 months 1 times per week of cognitive functional therapy. |
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| Core strengthening group | Active Comparator | The group will receive 4 months 1 times per week of an exercise program aming core strengthening. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Functional Therapy | Other | A physicaltheapy approach combining cognitive techniques, func-tional movement training, functional integration and Lifestyle Changes. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fear-Avoidance Beliefs | Fear-Avoidance Beliefs Questionnaire (FABQ) | through study completion, an average of 2 years |
| 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. |
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Eligible participants were
Exclusion criteria were
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra-Hristara Papadopoulou, Professor | International Hellenic University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Therapy Clinic Trevlakis Emmanouil | Thessaloniki | Thessaloniki | 54635 | Greece |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Two arms, parallel-design, assessor-blinded randomized controlled trial
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| Exercise program: | Other | Core strengthening program |
|
| 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 |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001416 | Back Pain |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |