The Effect of Cognition Targeted Physical Therapy in People With Non-specific Neck Pain

NCT05127603 | Completed

• 1 other identifier: HR01_MCS_NeckPain
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore and evaluate the effects of an individually tailored intervention focusing on influencing dysfunctional illness perceptions and dysfunctional movement/pain behavior in patients with non-specific neck pain.

Conditions

Neck Pain

Keywords

Pain; Psychological Intervention; Qualitative evaluation; Quantitative evaluation

Outcome Measures

Primary Outcomes (2)

• Change in qualitative outcomes on illness perceptions, coping, self-perceived health condition and evaluating treatment: two semi-structured interviews will be conducted

  An exploration of changes in (1) illness perceptions, (2) how people cope with their neck pain, (3) their perceived health condition and (4) to what they attribute a change in their perceived health condition during individually tailored physiotherapy treatment

  Change in illness perceptions, coping and health condition from week 1 (i.e. mid-baseline, one week before the start of the intervention phase) till a week after the end of the intervention (i.e. week 9 or 10)

• Change in Global Perceived Effect Scale (GPES) (7-points Likert scale) (Quantitative outcome measurement)

  The GPES is a self-administered measure used to investigate the participant's perception of effect from the intervention they received. The GPES is scored on a seven-level Likert scale (1=Very much improved, 2=Much improved, 3=A little improved, 4=No change, 5=A little deterioration, 6=Much deterioration, 7=Very much deterioration)

  Immediately after the first treatment consultation (week 3) and the second (week 4), third (week 5), fourth (week 6) and the fifth (+sixth/seventh) consultation (week 7 (+8/9) and at 3 months after the last consultation (i.e. follow up week 19/21)

Secondary Outcomes (3)

• Pain Self-Efficacy (assessed by the Pain Self-Efficacy Questionnaire (PSEQ-2 / PSEQ-4))

  Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation (regardless of whether this was the 5th, 6th or 7th consultation)

• Functional Disability (assessed by the Patient Specific Functional Scale (PSFS))

  Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation

• Average Pain Intensity (assessed by the Numeric Pain Rating Scale (NPRS))

  Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation

Other Outcomes (2)

• Illness Perceptions (assessed by the Brief Illness Perception Questionnaire (B-IPQ))

  Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation

• Fear avoidance Beliefs (assessed by the Fear Avoidance Belief Questionnaire- physical activity subscale)

  Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation

Study Arms (1)

Individually tailored physiotherapy; cognitive behavioral intervention

EXPERIMENTAL

The intervention is offered in accordance with the Neck Pain Guidelines, with a focus on influencing dysfunctional illness perceptions and dysfunctional movement/ pain behavior.

Behavioral: Cognitive behavioral intervention

Interventions

Cognitive behavioral intervention BEHAVIORAL

Individually tailored physiotherapy that fits within the guideline non-specific neck pain (KNGF, 2016) with a focus on influencing dysfunctional illness perceptions and dysfunctional movement/ pain behavior, by means of communication, body awareness exercises, functional movements and exposure techniques. Tools are supplied to create an appropriate explanatory model for the pain, for functional movement behavior and active coping in a patient's daily lives.

Individually tailored physiotherapy; cognitive behavioral intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neck pain with no signs of major pathology, but with interference on daily activities (i.e., neck pain Grade II
• Aged 18-65
• The neck pain is present for a minimum of 2 weeks and pain and/or disability continues or increases
• A minimum score of 4 on the Start Neck Tool
• Good command of the Dutch language

You may not qualify if:

• Neck pain with neurological signs (i.e., neck pain Grade III) or neck pain with signs of serious pathology (i.e., neck pain Grade IV)
• Psychiatric disorders
• Surgery in the neck-arm area (\< 3 months) and/or an acute mechanical trauma (\< 3 weeks) in history

Sponsors & Collaborators

• Rotterdam University of Applied Sciences: lead
• VU University of Amsterdam: collaborator
• Multiple primary care physical therapy clinics: collaborator

Study Sites (1)

Rotterdam University of Applied Sciences

Rotterdam, South Holland, 3015 CX, Netherlands

Location

MeSH Terms

Conditions

Neck Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Michel Coppieters, Prof.

  VU Amsterdam, The Netherlands; Griffith University, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD-student, Physical Therapist and Lecturer

Model Details: Single Case methodology with a baseline (phase A), intervention (phase B) and intervention withdrawal phase (A') This multiple case study has three phases: (A) A baseline phase of two weeks with no intervention, (B) a treatment phase with 5-7 consultations (offered weekly) and (A') a follow-up 3 months after the last treatment consultation. The participants are seen as single systems in both the qualitative as the quantitative analyses in an experimental design, using a tailored care physiotherapy intervention, in which the participants act as their own controls.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 19, 2021
• Study Start: November 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: April 3, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Informed Consent Form (ICF) - English language version will be available from the start of the study \[1-11-2021\] till the end of the study \[expected date:1-11-2022\]
• Access Criteria: Investigators whose proposed use of the data has been approved by the national ethics committee. Proposals should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement.

Locations

NL (1)