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

The Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06225063
Enrollment
60
Registered
2024-01-25
Start date
2023-08-15
Completion date
2024-09-30
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Neck Pain

Brief summary

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.

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.

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

Sponsors

European University Cyprus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Scalebaseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomizationMeasured pain intensity with 0 (no pain) and 100 (the worst pain ever).
Neck Disability Indexbaseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomizationThis 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).

Secondary

MeasureTime frameDescription
EuroQol (EQ-5D)baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomizationAn 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)
Fear Avoidance Beliefs Questionnairebaseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomizationThis 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).
Isometric Strengthbaseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomizationStrength in all cervical movements (flexion, extension, side flexion, rotations)
Range of Motionbaseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomizationRange of motion in all cervical movements (flexion, extension, side flexion, rotations)
Short Form 12baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomizationThis 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.

Countries

Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026