Clinical trial NCT06063408: The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain
Official title: The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic neck pain
Lead sponsor: European University Cyprus
Sponsor class: OTHER
First posted: 2023-10-02
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 was to compare the effectiveness of Cognitive Functional Therapy compared with Conventional Therapy in treating adults with chronic neck pain

Detailed description: After being informed about the study and potential risks, all patients giving written informer consent will undergo 1 week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility criteria will be randomized in a single- blind manner (assessor), in a 1:1 ration to cognitive functional therapy or conventional therapy twice a week for 8 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 mobile (with or without aids), 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 (e.g epidurals) and day case procedures (e.g rhizotomy) in the last 3 months
* Pregnancy
* Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, lupus, scheuermann's disease)
* Progressive neurological disease (e.g. multiple sclerosis (MS), parkinson's disease (PD), motor neuron disease (MND)
* Unstable cardiac conditions
* Red flag disorders like 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 Fort 12
timeFrame: Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
measure: EurQqol 5
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: European University of Cyprus
state: Engomi
Study officials:
References: