The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain

Chronic Pain Clinical Trial

Official title:

The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain: A Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063408
• Other study ID #: 0101100333
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: European University Cyprus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to compare the effectiveness of Cognitive Functional Therapy compared with Conventional Therapy in treating adults with chronic neck pain

Description:

After being informed about the study and potential risks, all patients giving written informer consent will undergo 1 week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility criteria will be randomized in a single- blind manner (assessor), in a 1:1 ration to cognitive functional therapy or conventional therapy twice a week for 8 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age 18-64
• Pain in neck area for more than 3 months
• Pain in NPRS more than 40/100
• Independently mobile (with or without aids), to be capable of participating in a rehabilitation program twice a week

Exclusion Criteria:

• Serious psychological pathology
• recently surgery on shoulder or neck area (<6 months)
• Pain relieving procedures such as injection based therapy (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
• Pregnancy
• Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease)
• Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND)
• Unstable cardiac conditions
• Red flag disorders like malignancy/cancer, acute traumas like fracture (<6 months ago) or infection, spinal cord compression/cauda equina

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

Behavioral:
• Cognitive Functional Therapy
Cognitive functional therapy (CFT) is a novel intergraded behavioral approach for individualizing the management of spinal pain, targeting the bio-psycho-social factors of rehabilitation, and enabling the patient to self-manage the condition. CFT lies within the broad spectrum of the biopsychosocial approach for the management of spinal pain. CFT uses a multidimensional clinical reasoning framework with aim to enable the clinician to identify modifiable components of the condition, evaluate patients' behavioral responses to pain, and compose and drive a tailored rehabilitation program mainly based on self-management. The intervention is comprised by the interplay on "making sense of pain", "exposure with control", and "lifestyle change".
• Conventional Therapy
Each individual session involve a combination of pain management with electrotherapy, massage and relaxation techniques. Also include some posture exercise these will be targeted on body alignment to the neutral position, and strengthening the whole neck area. strengthening program will be include isometrics on all cervical movements with a band which progressively increase the resistance of the band by change it and process to exercise against the band resistant. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.

Locations

Country	Name	City	State
Cyprus	European University of Cyprus	Nicosia	Engomi

Sponsors (1)

Lead Sponsor	Collaborator
European University Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating scale	Measured pain intensity with 0 no pain and 100 the worst pain ever.	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Primary	Neck Disability Index	This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.; 0= no disability 100= severe disability	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Secondary	Fear Avoidance Beliefs Questionnaire	The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.; The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Secondary	Short Fort 12	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Secondary	EurQqol 5	An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient or respondent.; Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Secondary	Range of motion	Range of motion in all cervical movement, flexion, extension, side flexion, rotations	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Secondary	Isometric Strength	Strength in all cervical movement, flexion, extension, side flexion, rotations	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)