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CompletedNCT06063408Updated Aug 11, 2026

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

An interventional study of Cognitive Functional Therapy and Conventional Therapy in Chronic Pain, sponsored by European University Cyprus. Completed at 1 site in Cyprus. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by European University Cyprus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Pain

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Keywords

  • Chronic neck pain
03

In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

European University Cyprus is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-64
  • Pain in neck area for more than 3 months
  • Pain in NPRS more than 20/100
  • Independently mobile (with or without aids), to be capable of participating in a rehabilitation program twice a week

Exclusion criteria

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 /cancer, acute traumas like fracture (\<6 months ago) or infection, spinal cord compression/cauda equina
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Cognitive Functional Therapy

  • Active comparator
    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

    Behavioral: Conventional Therapy

Interventions

  • BehavioralCognitive 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".

    Also known as: CFT

  • BehavioralConventional 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.

    Also known as: CT

06

What researchers measure

Primary outcomes

  1. Numerical rating scale

    Measured pain intensity with 0 no pain and 100 the worst pain ever.

    Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

  2. 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

    Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

Secondary outcomes

  1. 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.

    Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

  2. 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

    Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

  3. 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.

    Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

  4. Range of motion

    Range of motion in all cervical movement, flexion, extension, side flexion, rotations

    Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

  5. Isometric Strength

    Strength in all cervical movement, flexion, extension, side flexion, rotations

    Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

07

Study locations

1 site
  • European University of Cyprus
    Nicosia, Engomi 2404, Cyprus
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06063408
Lead sponsor
European University Cyprus
Responsible party
George Ploutarchou (Principal Investigator, European University Cyprus) — Principal investigator
First posted
Oct 2, 2023
Start date
Sep 15, 2024
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024
Last update
Aug 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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