The Effect of Cognition Targeted Physical Therapy in People With Non-specific Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

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:

      In this study a Single Subject Experimental Design (SSED) is applied with a baseline phase
      (duration two weeks), an intervention phase with 5-7 treatment consultations (offered once a
      week) and a follow up (3 months after the last consultation).

      During the baseline phase, a qualitative assessment of the illness perceptions, the way
      people cope with pain and their self-perceived health condition, is carried out through a
      semi-structured interview. A second interview is carried out after the treatment phase (in
      the week after the last treatment consultation) to explore changes in (1) the illness
      perceptions, (2) the way people cope with pain, (3) their self-perceived health condition and
      to explore to what these participants attribute a change in their perceived health condition.

      The quantitative part of the study is used to investigate whether influencing illness
      perceptions (measured by the B-IPQ and the FABQ-pa) is a mediating factor for the treatment
      effect (i.e. self-perceived effect measured by the GPE scale, self-efficacy (PSEQ),
      functioning (PSFS) and pain (NPRS)). Outcome measurements in this quantitative part of the
      study will be performed two times a week during the baseline phase and the intervention
      phase. The last measurement in the intervention phase will be performed in the week after the
      treatment is completed (depending on the individual situation after 5-7 weeks of
      consultations). A follow-up measurement will be performed 3 months after the last treatment
      consultation.

      Participants:

      People with non-specific neck pain and a middle or high risk profile for chronicity (i.e. a
      score of ≥ 4 on the Start Neck Tool) are the target group for this study.

      Procedure:

      The study will be conducted in collaboration with 11 local physiotherapy clinics in primary
      health care. People with non-specific neck pain will be recruited via information on the
      website or social media channels of the physical therapy practices, via posters in the
      waiting room, via the secretary upon registration and via the physical therapist after the
      (regular) screening. After being screened by a physical therapist and when fulfilling the
      inclusion and exclusion criteria, information is given about the study. When willing to
      participate and after reading the information letter and signing the informed consent,
      patients will be included in the study. Their decision on participating in the study will not
      have consequences for their treatment. From enrollment, the participants will fill in the
      baseline measurements on the outcome variables twice a week and contact the researcher for
      making an appointment for an interview. The interview, performed by the leading researcher,
      will take place half way the baseline period of two weeks. In this interview the
      participant's illness perceptions, how they cope with their neck pain and their
      self-perceived health condition will be explored. Two weeks after enrollment in the study the
      intervention will start. The intervention, with a total of 5 till 7 treatment consultations
      depending on the patient's needs, is offered once a week by a trained physical therapist.
      During this phase, the self-reported outcome measures will be collected twice a week using
      questionnaires. The data from these questionnaires will be used to tailor the intervention.
      Within a week of completing the intervention, the researcher will be contacted and a second
      interview will take place. In addition to a further exploration of the participant's illness
      perceptions, how they cope with their pain and their self-perceived health condition at the
      end of the intervention, it is also evaluated to what the participant attributes a possible
      change in the perceived health condition and what the role of the intervention has been.
      Three months after the last treatment consultation, a follow up measurement will be conducted
      by completing a questionnaire on the aforementioned outcome variables.

      Intervention:

      The intervention consists of individually tailored physiotherapy that fits within the
      guideline non-specific neck pain (KNGF, 2016), with a focus on influencing dysfunctional
      illness perceptions and movement/pain behavior by means of communication, body awareness
      exercises, functional movements and exposure techniques. Depending on the patient's needs,
      5-7 treatment consultations will be offered with a frequency of once a week. The intervention
      will be delivered by a trained physical therapist with specific interests in a
      cognitive-behavioral approach within a biopsychosocial model. The aim of the intervention is
      to influence dysfunctional beliefs and negative emotions to increase their self-perceived
      health condition and confidence in carrying out specific activities despite their pain and
      fulfill the patient's individually formulated goals.

      Analyses:

      This mixed method multiple case design implies the study of the clinical progress in an
      experimental set up by both a qualitative evaluation and frequent measurements of several
      quantitative outcome variables in a small sample of participants during a pre-intervention
      phase (A), an intervention phase (B) and an intervention withdrawal phase (A').

      Qualitative analyses: Within the qualitative part of the study a content analysis will be
      conducted using the inductive analytical approach. The following steps will be taken: 1. Open
      coding (identifying domains and topics guided by the research questions) 2. Development of
      categories into a framework 3. Interpretation of the raw data 4. Discussion about the
      interpretations.

      Quantitative analyses: Within the quantitative part of the study the participants are seen as
      single systems in the analyses and they act as their own controls. Repeated measures will be
      used to verify whether changes in specific illness perceptions (i.e. cognitions and emotions
      measured by the IPQ-k and FABQ-pa) mediates the effect of an individually tailored
      physiotherapy cognitive behavioral intervention on Global Perceived Effect, Self-efficacy,
      Functioning and Pain. Furthermore this quantitative research will be used to validate the
      data and interpretations from the interviews (i.e. to check whether 'the story people tell'
      corresponds to more objective markers (triangulation)).

      Complementary Data:

      Complementary data that will be collected within the project are the characteristics of the
      participating physical therapists (i.e. gender, age, work experience and specializations) and
      treatment related data (i.e. the number of physiotherapy sessions, the focus area within a
      session and the use of specific tools).
    

Intervention name(s): Cognitive behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Psychological Intervention; Qualitative evaluation; Quantitative evaluation