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

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

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: Pilates; Other: Cognitive Functional Therapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus
    • Evi Lazoura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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)	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)	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)	baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization

Collaborators and Investigators

• Sponsor: European University Cyprus
• Investigators: Study Director: Evi Lazoura, PhD (cand), European University Cyprus

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: ΕΕΒΚ/ΕΠ/2023/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No