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

NCT06063408 | Completed

• 1 other identifier: 0101100333
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain

Keywords

Chronic neck pain

Outcome Measures

Primary Outcomes (2)

• Numerical rating scale

  Measured pain intensity with 0 no pain and 100 the worst pain ever.

  Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

• 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

  Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

Secondary Outcomes (5)

• Fear Avoidance Beliefs Questionnaire

  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)

• EurQqol 5

  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)

• Isometric Strength

  Baseline (after randomization), at 4th week (after 8th session), at 8th week (after 16th session), 3 months (after randomization)

Study Arms (2)

Cognitive Functional Therapy

EXPERIMENTAL

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.

Behavioral: Cognitive Functional Therapy

Conventional Therapy

ACTIVE COMPARATOR

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

Behavioral: Conventional Therapy

Interventions

Cognitive Functional Therapy 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".

Also known as: CFT

Cognitive Functional Therapy

Conventional Therapy 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.

Also known as: CT

Conventional Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European University Cyprus: lead

Study Sites (1)

European University of Cyprus

Nicosia, Engomi, 2404, Cyprus

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 2, 2023
• Study Start: September 15, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CY (1)