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

Chronic Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225063
• Other study ID #: ????/??/2023/20
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: European University Cyprus
• Contact: Evi Lazoura
• Phone: 00357 22559565 - 5565
• Email: evi.lazoura[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Cyprus	Evi Lazoura	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
European University Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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