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

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: Conventional Therapy; Behavioral: Cognitive Functional Therapy

• Registration Number: NCT06063408
• Lead Sponsor: European University Cyprus

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2023-08-15
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-04-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Therapy	Conventional Therapy	Participants will received in this group four main component: 1. Tens therapy 2. Massage to cervical and shoulder area 3. Relaxation techniques 4. Posture exercises 5. Workplace education
Cognitive Functional Therapy	Cognitive Functional Therapy	Participants will received in this group four main component: 1. Pain education, cognitive education, explanation about their health condition, self management education 2. Graded exposure to painful movements or activities 3. Movement therapy targeted to their functional integration 4. Lifestyle programme.

Primary Outcome Measures

Name	Time	Method
Numerical rating scale	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)	Measured pain intensity with 0 no pain and 100 the worst pain ever.
Neck Disability Index	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)	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

Secondary Outcome Measures

Name	Time	Method
EurQqol 5	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)	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.
Isometric Strength	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)	Strength in all cervical movement, flexion, extension, side flexion, rotations
Short Fort 12	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)	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
Range of motion	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)	Range of motion in all cervical movement, flexion, extension, side flexion, rotations
Fear Avoidance Beliefs Questionnaire	Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)	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.

Trial Locations

Locations (1)

European University of Cyprus; 🇨🇾 Nicosia, Engomi, Cyprus