ClinicalTrials.gg
CompletedNCT06225063Updated Mar 3, 2025

The Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain

An interventional study of Pilates and Cognitive Functional Therapy in Chronic Neck 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 2025-03-03.

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

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2023, registered Jan 2024).
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 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.

02

Conditions studied

  • Chronic Neck Pain

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03

In context

Neck Pain

1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 1,116 interventional studies indexed under Neck Pain.

Browse Neck 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 40/100
  • Independently mobility (with or without aid), 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 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 (/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
    Pilates Group

    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.

    Other: Pilates

  • Experimental
    Cognitive Functional Therapy

    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

    Other: Cognitive Functional Therapy

Interventions

  • OtherPilates

    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.

    Also known as: pilates exercises

  • OtherCognitive Functional Therapy

    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

    Also known as: CFT

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 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).

    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

    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).

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

  2. 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.

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

  3. 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)

    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 movements (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 movements (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
  • Evi Lazoura
    Nicosia, Cyprus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Aug 2024, 12 months.

Of 763 non-industry interventional studies with no phase under Neck Pain, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 12 months is above that.

Counting every sponsor, half of 772 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2024
First posted
Jan 25, 2024
StartActual
Aug 15, 2023
Primary completionActual
Aug 31, 2024
CompletionActual
Sep 30, 2024
Last update
Mar 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06225063
Lead sponsor
European University Cyprus
Responsible party
Evi Lazoura (Physiotherapist, MSc, PhD (cand.), European University Cyprus) — Principal investigator
First posted
Jan 25, 2024
Start date
Aug 15, 2023
Primary completion
Aug 31, 2024
Completion
Sep 30, 2024
Last update
Mar 3, 2025

Study contacts

Evi Lazoura, PhD (cand)
study director · European University Cyprus

Oversight

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

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