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

NCT06225063 | Completed

• 1 other identifier: ΕΕΒΚ/ΕΠ/2023/20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale

  Measured pain intensity with 0 (no pain) and 100 (the worst pain ever).

  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).

  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

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

• Short Form 12

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

• EuroQol (EQ-5D)

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

• Range of Motion

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

• Isometric Strength

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

Study Arms (2)

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.

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

Other: Cognitive Functional Therapy

Interventions

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.

Also known as: pilates exercises

Pilates Group

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

Also known as: CFT

Cognitive Functional Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• European University Cyprus: lead

Study Sites (1)

Evi Lazoura

Nicosia, Nicosia, Cyprus

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Evi Lazoura, PhD (cand)

  European University Cyprus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc, PhD (cand.)

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: January 25, 2024
• Study Start: August 15, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: March 3, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)