Neck PainNCT05127603
The Effect of Cognition Targeted Physical Therapy in People With Non-specific Neck Pain
A study testing Cognitive behavioral intervention in people with Neck Pain, run by Rotterdam University of Applied Sciences at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cognitive behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 3 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Rotterdam University of Applied Sciences
Rotterdam, South Holland, 3015 CX
About this study
Official title: The Effect of Cognition Targeted Physical Therapy in People With Non-specific Neck Pain: A Mixed-Method Multiple Case Study
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.
Read the 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:
- 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?
- 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).
- Conditions
- Neck Pain
- Being tested
- Cognitive behavioral intervention
- Keywords
- Pain, Psychological Intervention, Qualitative evaluation, Quantitative evaluation
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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))
The Pain Self-Efficacy Questionnaire (PSEQ-2 / PSEQ-4) is used to assess participants' level of confidence in performing activities despite their pain. 5 Items scored on a 0 - 6 Scale (0=not at all confident, 6 = completely confident).
Measured: 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))
The Patient Specific Functional Scale (PSFS) is used to identify and measure changes in the participant's ability to perform up to two self-selected activities regarded as important by them. Ability levels scored 0 - 10 (0= able to perform activity at the same level as before injury or problem, 10 = unable to perform activity)
Measured: 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))
The average pain intensity within the last week (7 days) is measured by a 11-point numeric pain rating scale (NPRS) ranging from 0='no pain' to 10='worst pain imaginable'.
Measured: Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Mar 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rotterdam University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, Multiple primary care physical therapy clinics
- Responsible party
- Principal investigator, Maaike Kragting, Rotterdam University of Applied Sciences
- Investigators
- Michel Coppieters, Prof., Study chair, VU Amsterdam, The Netherlands; Griffith University, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127603
- Sponsor's protocol ID
- HR01_MCS_NeckPain
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available to share include the quantitative data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognition Targeted Physical Therapy in People With Non-specific Neck Pain: A Mixed-Method Multiple Case Study
- ClinicalTrials.gov ID
- NCT05127603
- Acronym / sponsor ID
- HR01_MCS_NeckPain
- Conditions
- Neck Pain
- Keywords
- Pain, Psychological Intervention, Qualitative evaluation, Quantitative evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rotterdam University of Applied SciencesUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, Multiple primary care physical therapy clinics
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individually tailored physiotherapy; cognitive behavioral intervention | Experimental | Behavioral: Cognitive behavioral interventionThe intervention is offered in accordance with the Neck Pain Guidelines, with a focus on influencing dysfunctional illness perceptions and dysfunctional movement/ pain behavior. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral interventionIndividually 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. | Behavioural | Individually tailored physiotherapy; cognitive behavioral intervention |
Primary outcome
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)
3 secondary outcomes
Pain Self-Efficacy (assessed by the Pain Self-Efficacy Questionnaire (PSEQ-2 / PSEQ-4))
Time frame: 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))
Time frame: 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))
Time frame: Scored twice a week from enrollment to the last (i.e. fifth, sixth or seventh) treatment consultation and three months after de last consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Data available to share include the quantitative data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Coppieters, Prof. study chair
VU Amsterdam, The Netherlands; Griffith University, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral intervention in people with Neck Pain, run by Rotterdam University of Applied Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.