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Completed

NCT Number: NCT06063408

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

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European University of Cyprus

Nicosia, Engomi, 2404, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Functional Therapy

Behavioral

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".

Other names: CFT

Conventional Therapy

Behavioral

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.

Other names: CT

Primary outcomes

  1. Numerical rating scale

    Time frame: 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.

  2. Neck Disability Index

    Time frame: 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 outcomes

  1. Fear Avoidance Beliefs Questionnaire

    Time frame: 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.

  2. Short Fort 12

    Time frame: 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

  3. EurQqol 5

    Time frame: 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.

  4. Range of motion

    Time frame: 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

  5. Isometric Strength

    Time frame: 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

Sponsors and collaborators

Lead sponsor

European University Cyprus

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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