The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain: A Pragmatic Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- European University Cyprus
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Numerical rating scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-64
- •Pain in neck area for more than 3 months
- •Pain in NPRS more than 20/100
- •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
Arms & Interventions
Cognitive Functional Therapy
Participants will received in this group four main component:
- Pain education, cognitive education, explanation about their health condition, self management education
- Graded exposure to painful movements or activities
- Movement therapy targeted to their functional integration
- Lifestyle programme.
Intervention: Cognitive Functional Therapy (Behavioral)
Conventional Therapy
Participants will received in this group four main component:
- Tens therapy
- Massage to cervical and shoulder area
- Relaxation techniques
- Posture exercises
- Workplace education
Intervention: Conventional Therapy (Behavioral)
Outcomes
Primary Outcomes
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.
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 has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. 0= no disability 100= severe disability
Secondary Outcomes
- EurQqol 5(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))
- Short Fort 12(Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization))
- Range of motion(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))
Investigators
George Ploutarchou
Principal Investigator
European University Cyprus