Back to resultsThe Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Cognitive Functional Therapy
Conventional Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic neck pain
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
Sites / Locations
- European University of CyprusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Functional Therapy
Conventional Therapy
Arm Description
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.
Participants will received in this group four main component: Tens therapy Massage to cervical and shoulder area Relaxation techniques Posture exercises Workplace education
Outcomes
Primary Outcome Measures
Numerical rating scale
Measured pain intensity with 0 no pain and 100 the worst pain ever.
Neck Disability Index
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 Outcome Measures
Fear Avoidance Beliefs Questionnaire
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.
The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Short Fort 12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
EurQqol 5
An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient or respondent.
Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.
Range of motion
Range of motion in all cervical movement, flexion, extension, side flexion, rotations
Isometric Strength
Strength in all cervical movement, flexion, extension, side flexion, rotations
Full Information
NCT ID
NCT06063408
First Posted
September 5, 2023
Last Updated
September 29, 2023
Sponsor
European University Cyprus
1. Study Identification
Unique Protocol Identification Number
NCT06063408
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University Cyprus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Functional Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Participants will received in this group four main component:
Tens therapy
Massage to cervical and shoulder area
Relaxation techniques
Posture exercises
Workplace education
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Functional Therapy
Other Intervention Name(s)
CFT
Intervention Description
Cognitive functional therapy (CFT) is a novel intergraded behavioral approach for individualizing the management of spinal pain, targeting the bio-psycho-social factors of rehabilitation, and enabling the patient to self-manage the condition.
CFT lies within the broad spectrum of the biopsychosocial approach for the management of spinal pain. CFT uses a multidimensional clinical reasoning framework with aim to enable the clinician to identify modifiable components of the condition, evaluate patients' behavioral responses to pain, and compose and drive a tailored rehabilitation program mainly based on self-management. The intervention is comprised by the interplay on "making sense of pain", "exposure with control", and "lifestyle change".
Intervention Type
Behavioral
Intervention Name(s)
Conventional Therapy
Other Intervention Name(s)
CT
Intervention Description
Each individual session involve a combination of pain management with electrotherapy, massage and relaxation techniques. Also include some posture exercise these will be targeted on body alignment to the neutral position, and strengthening the whole neck area. strengthening program will be include isometrics on all cervical movements with a band which progressively increase the resistance of the band by change it and process to exercise against the band resistant. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.
Primary Outcome Measure Information:
Title
Numerical rating scale
Description
Measured pain intensity with 0 no pain and 100 the worst pain ever.
Time Frame
Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Title
Neck Disability Index
Description
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
Time Frame
Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Secondary Outcome Measure Information:
Title
Fear Avoidance Beliefs Questionnaire
Description
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.
The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Time Frame
Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Title
Short Fort 12
Description
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time Frame
Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Title
EurQqol 5
Description
An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient or respondent.
Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.
Time Frame
Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Title
Range of motion
Description
Range of motion in all cervical movement, flexion, extension, side flexion, rotations
Time Frame
Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
Title
Isometric Strength
Description
Strength in all cervical movement, flexion, extension, side flexion, rotations
Time Frame
Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
European University of Cyprus
City
Nicosia
State/Province
Engomi
ZIP/Postal Code
2404
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Γιωργος Πλουταρχου
Phone
99915998
Email
g.ploutarchou@external.euc.ac.cy
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain
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