Chronic Neck PainNCT06225063
The Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain
A study testing Pilates and Cognitive Functional Therapy in people with Chronic Neck Pain, run by European University Cyprus at 1 site in Cyprus.
Trial summary
The aim of this study is to compare the effectiveness of Pilates compared with Cognitive Functional Therapy in 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 Neck Pain
- What is being tested?
- Pilates and Cognitive Functional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Aug 2023to 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 40/100
- Independently mobility (with or without aid), 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 and day case procedures (e.g. rhizotomy) in the last 3 months
- Pregnancy
- Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, Scheuermann's disease)
- Progressive neurological disease (e.g. Multiple Sclerosis, Parkinson's disease, Motor Neuron Disease)
- Unstable Cardiac Conditions
- Red flags disorders (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 Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain: a Randomized Controlled Trial
The aim of this study is to compare the effectiveness of Pilates compared with Cognitive Functional Therapy in adults with chronic neck pain.
Read the detailed description
Firstly, people being informed about the study and those who determine eligibility criteria they written informer consent. After this, the participants will be randomized by a single-blind assessor in a 1:1 ration to pilates exercises and cognitive functional therapy. The participants of both groups will receive therapy twice a week for eight weeks.
- Conditions
- Chronic Neck Pain
- Being tested
- Pilates, Cognitive Functional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Also called pilates exercises
The application of pilates aims to correct real-time deviations observed in the body during movement, to maintain stability, to maintain stability, to gradually form proper sensorimotor ability and improve cervical dysfunction. Pilates is an important part but also a primary point in the stages of rehabilitation, since through it the execution of movement is encouraged earlier thus providing help for the later stages of rehabilitation. Pilates exercises concern movements at all levels of body movement and in various positions.
Cognitive Functional TherapyOther
Also called CFT
Cognitive component: Educating patients about their perceptions of pain, explaining diagnosis and diagnostic findings, answering questions about their problem and symptoms, progressively challenge their customers in a non-judgmental way, education for multifactorial and biopsychosocial spectrum of pain, encouraging participants to movement and for active participation in daily activities, if receiving a self-management plan participation in activities with a degree of difficulty 2-3/10, tips for more effective sleep Specific functional training: Understanding pain modification through relaxation exercises, awareness and body control, modified body positions for better control of the cervical spine with parallel relaxation of the thoracic spine to participate in fearful or painful activities, engaging in movements of daily activities Lifestyle changes: Gradual increase in physical activity based on patient preferences, stress management and social interaction
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | In the first session participants will received the 6 basic principles of the technique. All the other sessions will last 50 minutes and consist of warm-up, main program and cool-down exercises. The degree of difficulty of the exercises of the main part will progress every 2 weeks. Receives: Other: Pilates |
| Cognitive Functional Therapy | Experimental | In this group the participants will receive personalized treatment and therefore the sessions will be done individually for each one. All interventions will include a) a cognitive component, b) specific functional training and c) lifestylwe changes Receives: Other: Cognitive Functional 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 informed us about the affection to have the neck pain in human ability to manage it in everyday life. Measured neck disability with 4 (absence of disability) and >35 (full 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
This questionnaire informed us how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their cervical pain and resulting disability, with 96 (high levels of patient fear) and 0 (absence of patient fear).
Measured: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
Short Form 12
This questionnaire assessed the impact of health on an individual's everyday life, with 0-42 indicates the possible existence of clinical depression and <42 indicates good psychological as well as physical functioning.
Measured: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
EuroQol (EQ-5D)
An EQ-5D health state is the state of responses to the 5 dimensions of EQ-5D as completed by a patient, with 0 (the worst imaginable health state) and 100 (the best imaginable health state)
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 movements (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 movements (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 posted25 Jan 2024
- Study start15 Aug 2023
- Primary completion31 Aug 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 Neck 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, Evi Lazoura, European University Cyprus
- Investigators
- Evi Lazoura, PhD (cand), Study director, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225063
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2023/20
- Status last verified
- May 2024
- First submitted
- 13 Jan 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06225063
- Acronym / sponsor ID
- ΕΕΒΚ/ΕΠ/2023/20
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 25 Jan 2024 (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 is to compare the effectiveness of Pilates compared with Cognitive Functional Therapy in adults with chronic neck pain.
Detailed description
Firstly, people being informed about the study and those who determine eligibility criteria they written informer consent. After this, the participants will be randomized by a single-blind assessor in a 1:1 ration to pilates exercises and cognitive functional therapy. The participants of both groups will receive therapy twice a week for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: PilatesIn the first session participants will received the 6 basic principles of the technique. All the other sessions will last 50 minutes and consist of warm-up, main program and cool-down exercises. The degree of difficulty of the exercises of the main part will progress every 2 weeks. |
| Cognitive Functional Therapy | Experimental | Other: Cognitive Functional TherapyIn this group the participants will receive personalized treatment and therefore the sessions will be done individually for each one. All interventions will include a) a cognitive component, b) specific functional training and c) lifestylwe changes |
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 40/100
- Independently mobility (with or without aid), 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 and day case procedures (e.g. rhizotomy) in the last 3 months
- Pregnancy
- Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, 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 |
|---|---|---|
| PilatesAlso: pilates exercisesThe application of pilates aims to correct real-time deviations observed in the body during movement, to maintain stability, to maintain stability, to gradually form proper sensorimotor ability and improve cervical dysfunction. Pilates is an important part but also a primary point in the stages of rehabilitation, since through it the execution of movement is encouraged earlier thus providing help for the later stages of rehabilitation. Pilates exercises concern movements at all levels of body movement and in various positions. | Other | Pilates Group |
| Cognitive Functional TherapyAlso: CFTCognitive component: Educating patients about their perceptions of pain, explaining diagnosis and diagnostic findings, answering questions about their problem and symptoms, progressively challenge their customers in a non-judgmental way, education for multifactorial and biopsychosocial spectrum of pain, encouraging participants to movement and for active participation in daily activities, if receiving a self-management plan participation in activities with a degree of difficulty 2-3/10, tips for more effective sleep Specific functional training: Understanding pain modification through relaxation exercises, awareness and body control, modified body positions for better control of the cervical spine with parallel relaxation of the thoracic spine to participate in fearful or painful activities, engaging in movements of daily activities Lifestyle changes: Gradual increase in physical activity based on patient preferences, stress management and social interaction | Other | Cognitive Functional 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 informed us about the affection to have the neck pain in human ability to manage it in everyday life. Measured neck disability with 4 (absence of disability) and >35 (full 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 Form 12
Time frame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
EuroQol (EQ-5D)
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 3 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Evi Lazoura, PhD (cand) study director
European University Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Cognitive Functional Therapy in people with Chronic Neck 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 3 Mar 2025. 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 3 Mar 2025.