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

Not Applicable

Completed

• Conditions: Chronic Neck Pain
• Interventions: Other: Cognitive Functional Therapy; Other: Pilates

• Registration Number: NCT06225063
• Lead Sponsor: European University Cyprus

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.

Study Timeline

• Study Start: 2023-08-15
• Study First Submitted: 2024-01-13
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-25
• Status Verified: 2024-05
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Functional Therapy	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
Pilates Group	Pilates	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.

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	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).
Numerical Rating Scale	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).

Secondary Outcome Measures

Name	Time	Method
EuroQol (EQ-5D)	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)
Range of Motion	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)
Isometric Strength	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)
Fear Avoidance Beliefs Questionnaire	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).
Short Form 12	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.

Trial Locations

Locations (1)

Evi Lazoura; 🇨🇾 Nicosia, Cyprus