The Effectiveness of Cognitive Functional Therapy in Adults With Chronic Neck Pain

NCT ID: NCT06063408

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Functional Therapy

Participants will received in this group four main component:

1. Pain education, cognitive education, explanation about their health condition, self management education
2. Graded exposure to painful movements or activities
3. Movement therapy targeted to their functional integration
4. Lifestyle programme.

Group Type EXPERIMENTAL

Cognitive Functional Therapy

Intervention Type BEHAVIORAL

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".

Conventional Therapy

Participants will received in this group four main component:

1. Tens therapy
2. Massage to cervical and shoulder area
3. Relaxation techniques
4. Posture exercises
5. Workplace education

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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Cognitive Functional Therapy

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

Conventional Therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CFT CT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European University Cyprus

OTHER

Sponsor Role lead

Responsible Party

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George Ploutarchou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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European University of Cyprus

Nicosia, Engomi, Cyprus

Site Status RECRUITING

Countries

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Cyprus

Facility Contacts

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Γιωργος Πλουταρχου

Role: primary

Other Identifiers

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0101100333

Identifier Type: -

Identifier Source: org_study_id

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