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Clinical Trials/NCT05127603
NCT05127603CompletedNot Applicable

The Effect of Cognition Targeted Physical Therapy in People With Non-specific Neck Pain: A Mixed-Method Multiple Case Study

Rotterdam University of Applied Sciences1 site in 1 country14 target enrollmentStarted: November 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14
Locations
1
Primary Endpoint
Change in qualitative outcomes on illness perceptions, coping, self-perceived health condition and evaluating treatment: two semi-structured interviews will be conducted

Study Overview

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.

Detailed Description

Introduction:

Worldwide, neck pain is the 3th most common disorder that interferes with people's daily functioning. Many people with neck pain consult a physical therapist because of their pain, however treatment effects are small. Recent studies in a broader group of people with musculoskeletal pain show that physical therapy interventions tailored to individual risk profiles for chronicity are more effective. Considering the importance of psychological prognostic factors in neck pain it is hypothesized that influencing dysfunctional cognitions and negative emotions affects the way people cope with their pain and therefore can influence their self-perceived health condition in a positive way.

Research questions:

  1. How does an individually tailored intervention that focuses on influencing dysfunctional illness perceptions and dysfunctional movement/ pain behavior change people's illness perceptions, the way they cope with their pain, their self-perceived health condition and to what do these people attribute this change?
  2. Do changes in specific illness perceptions (i.e. cognitions and emotions measured by the IPQ-k and FABQ-pa) mediate the effect of an individually tailored physiotherapy cognitive behavioral intervention measured by the Global Perceived Effect, Self-efficacy (PSEQ), Functioning (PSFS) and Pain (NPRS).

Design:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: Cognitive behavioral intervention (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: 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)

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

Time Frame: 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)

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)

Secondary Outcomes

  • 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)
  • 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)

Investigators

Sponsor
Rotterdam University of Applied Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maaike Kragting

Principal Investigator, PhD-student, Physical Therapist and Lecturer

Rotterdam University of Applied Sciences

Study Sites (1)

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