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Completed

NCT Number: NCT06225063

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

The aim of this study is to compare the effectiveness of Pilates compared with Cognitive Functional Therapy in adults with chronic neck pain.

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Key information

Conditions

Chronic Neck Pain

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evi Lazoura

Nicosia, Cyprus

About this study

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.

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 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)

Treatment and study plan

Pilates

Other

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.

Other names: pilates exercises

Cognitive Functional Therapy

Other

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

Other names: CFT

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 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 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

    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).

  2. Short Form 12

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

    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.

  3. EuroQol (EQ-5D)

    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 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)

  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 movements (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 movements (flexion, extension, side flexion, rotations)

Sponsors and collaborators

Lead sponsor

European University Cyprus

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Mar 3, 2025

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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