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Clinical Trials/NCT06225063
NCT06225063
Completed
Not Applicable

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

European University Cyprus1 site in 1 country60 target enrollmentAugust 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Neck Pain
Sponsor
European University Cyprus
Enrollment
60
Locations
1
Primary Endpoint
Neck Disability Index
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2023
End Date
September 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evi Lazoura

Physiotherapist, MSc, PhD (cand.)

European University Cyprus

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Range of Motion(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)
  • Isometric Strength(baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization)
  • 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)

Study Sites (1)

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