Clinical trial NCT06225063: The Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain
Official title: The Comparison of Pilates with Cognitive Functional Therapy in Adults with Chronic Neck Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Lead sponsor: European University Cyprus
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
measure: Neck Disability Index
timeFrame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
Secondary outcomes:
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
measure: Short Form 12
timeFrame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
measure: EuroQol (EQ-5D)
timeFrame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
measure: Range of Motion
timeFrame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
measure: Isometric Strength
timeFrame: baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months after randomization
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Evi Lazoura
Study officials:
affiliation: European University Cyprus
name: Evi Lazoura, PhD (cand)
role: STUDY_DIRECTOR
References: