Chronic PainNCT06063408
The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain
A study testing Cognitive Functional Therapy and Conventional Therapy in people with Chronic Pain, run by European University Cyprus at 1 site in Cyprus.
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 Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Cognitive Functional Therapy and Conventional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Sep 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain: A Pragmatic Randomized Controlled Trial
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.
- Conditions
- Chronic Pain
- Being tested
- Cognitive Functional Therapy, Conventional Therapy
- Keywords
- Chronic neck pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Functional TherapyBehavioural
Also called CFT
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 TherapyBehavioural
Also called CT
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Functional Therapy | Experimental | 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. Receives: Behavioral: Cognitive Functional Therapy |
| Conventional Therapy | Active comparator | 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 Receives: Behavioral: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
Measured pain intensity with 0 no pain and 100 the worst pain ever.
Measured: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
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
Measured: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Secondary outcomes (5)
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.
Measured: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
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
Measured: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
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.
Measured: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Range of motion
Range of motion in all cervical movement, flexion, extension, side flexion, rotations
Measured: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Isometric Strength
Strength in all cervical movement, flexion, extension, side flexion, rotations
Measured: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start15 Sep 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Ploutarchou, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063408
- Sponsor's protocol ID
- 0101100333
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06063408
- Acronym / sponsor ID
- 0101100333
- Conditions
- Chronic Pain
- Keywords
- Chronic neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Functional Therapy | Experimental | Behavioral: Cognitive Functional TherapyParticipants 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. |
| Conventional Therapy | Active comparator | Behavioral: Conventional TherapyParticipants 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Functional TherapyAlso: CFTCognitive 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". | Behavioural | Cognitive Functional Therapy |
| Conventional TherapyAlso: CTEach 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. | Behavioural | Conventional Therapy |
Primary outcome
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.
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
5 secondary outcomes
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)
Short Fort 12
Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
EurQqol 5
Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Range of motion
Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Isometric Strength
Time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Functional Therapy and Conventional Therapy in people with Chronic Pain, run by European University Cyprus at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (time frame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.