Effects of CFT in Individuals With CNLBP

NCT05351008 | Completed DMC

• 1 other identifier: IntHellenicUniv
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Neuropathic Low Back Pain

Keywords

Chronic pain; Neuropathic pain; Low back pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Fear-Avoidance Beliefs

  through study completion, an average of 2 years

• Anxiety

  through study completion, an average of 2 years

• 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.

  through study completion, an average of 2 years

Study Arms (2)

Cognitive Functional Therapy group

EXPERIMENTAL

The group will receive 4 months 1 times per week of cognitive functional therapy.

Other: Cognitive Functional Therapy

Core strengthening group

ACTIVE COMPARATOR

The group will receive 4 months 1 times per week of an exercise program aming core strengthening.

Other: Exercise program:

Interventions

Cognitive Functional Therapy OTHER

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

Cognitive Functional Therapy group

Exercise program: OTHER

Core strengthening program

Core strengthening group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Physical Therapy Clinic Trevlakis Emmanouil

Thessaloniki, Thessaloniki, 54635, Greece

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Low Back Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alexandra-Hristara Papadopoulou, Professor

  International Hellenic University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two arms, parallel-design, assessor-blinded randomized controlled trial

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 28, 2022
• Study Start: November 11, 2022
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)