Neck PainNCT04182035
The Effectiveness of Patient-tailored Treatment in Patients With (Sub)Acute Neck Pain
A study testing patient-tailored therapy, Non-patient tailored therapy: generalized exercise program and Education in people with Neck Pain and Acute Pain, run by University Ghent at 1 site in Belgium.
Trial summary
The purpose of the present study is to examine if a patient-tailored treatment program has a better effect on pain and disability than a non-patient tailored treatment or wait and see approach in patients with (sub)acute (recurrent) NSNP. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Acute Pain, Rehabilitation
- What is being tested?
- patient-tailored therapy, Non-patient tailored therapy: generalized exercise program and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2019to 31 Jan 2024
- 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
- Non-specific neck pain, pain located in the cervico-thoracic and posterior shoulder region; without dominant arm pain.
- NDI scores score ≥10 % (more than no disability) and ≤68 % (less than complete disability)
- (Sub)acute complaints: <3 months
- Recurrent complaints but no neck pain episode the previous 3 months.
- Mean pain intensity scores: NRS > 3/10
Who cannot join
- Structural pathology, confirmed by imaging (disk herniation, nerve root compression, radiculopathy, severe rheumatoid diseases, fractures, traumatic alterations…) Shoulder pathology, vestibular pathology.
- Risk stratification: Startback tool for neck pain: high risk group
- BMI > 30 kg/m²
- Other cardiovascular/metabolic/systemic/ neurological diseases, fibromyalgia or chronic fatigue syndrome
- Psychiatric illnesses, history of depression, serious catastrophizing thoughts and/or low treatment expectations.[52]
- Chronic complaints (>3 months) or traumatic onset of the complaints
Show all 12Show fewer
- Probable or definite neuropathic pain (according to the classification of Finnerup et al.)
- History of surgery in the head/neck or shoulder region
- Hypermobile patients
- Pregnancy or given birth in the preceding year.
- History of recurrent/chronic low back pain
- Primary headache
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effectiveness of Patient-tailored Treatment Versus Non Patient-tailored Treatment in Patients With Acute and Subacute Idiopathic Neck Pain
The purpose of the present study is to examine if a patient-tailored treatment program has a better effect on pain and disability than a non-patient tailored treatment or wait and see approach in patients with (sub)acute (recurrent) NSNP. A secondary goal is to evaluate the global perceived effect, treatment adherence, recurrence, work absenteeism and medication use. All interventional treatment arms will consist of a treatment part in a clinical practice setting, under supervision of a trained physiotherapist, and an educational intervention and will be compared to the control group.
Read the detailed description
Non-specific neck pain (NSNP) is a widespread health problems and a major cause of pain and disability. This condition is complex, disabling and has a heterogeneous presentation, which makes NSNP difficult to treat. Currently, the best evidence supports combining different forms of manual therapy (mobilizations, manipulations and manual muscle techniques), and exercises. Yet, identifying the most effective treatment characteristics and dosages remain challenging. Central in the debate about best practice management of NSNP and NSLBP is the efficacy of tailored versus generic (non-tailored) treatment. To date, sufficient evidence for the application of specific physiotherapy modalities or therapy aiming at specific NSNP subgroups is lacking. Although more research has already been conducted for the lumbar spine, there is an ongoing quest to identify relevant subgroups and provide patients with an assessment-driven targeted intervention to achieve meaningful and long-lasting changes.
Attempts have been made to identify relevant and homogeneous subgroups for patients with NSNP. Several classification systems have been proposed, based on (1) prognosis or (2) the underlying mechanism(s) driving the disorder: (2a) pain mechanisms, (2b) features of movement/posture/muscle activation , and (2c) pathology/diagnosis. The main goal of subgrouping patients is to enhance treatment efficiency. Nevertheless, a profound clinical reasoning process is necessary to identify clinically relevant subgroups. By identifying accurate and useful diagnostic criteria for NSNP and NSLBP, more informed decisions regarding the management of these conditions could be made.
Clinicians and researchers are hopeful that tailoring treatment to subgroups of patients may positively impact on patient outcomes and more efficient usage of health-care resources. For the lumbar spine, tailoring treatment to different subgroups is already present in literature. For example, in patients with pain provoked by postures/movements, tailoring treatment to modify specific features of posture/movement is effective and patients allocated to subgroups respond better to matched rather than unmatched interventions. Yet, other studies showed no additional benefit. Despite the growing interest for tailoring treatment for NSNP, the definition of tailored/stratified care is broadly used and interpretation is diverse. In order to determine best practice for the individual patient, tailoring the treatment should account for the multidimensional nature of non-specific spinal complaints and respect the individual characteristics of the patient within its subgroup. Additionally, it must take into account that patients may present with features of multiple subgroups or evolve through subgroups during treatments.
Previous studies on NSLBP already showed that targeting treatment can reduce costs and may improve outcomes when specific groups are compared. Unfortunately, at this moment, no conclusive high-quality evidence is present for its superiority. In addition to the lumbar spine, research on stratified care for NSNP is scarce compared to NSLBP research. Despite its major prevalence and socioeconomic consequences, no recommended or validated classification systems to stratify care for NSNP and to target specific subgroups are available. This suggests that the treatment decision in this heterogeneous group mostly depends on the clinical reasoning process, which is often incomplete in research on NSNP.
In order to evaluate the best practice for NSNP, a classification system based on a profound clinical reasoning process, identifying clinically relevant subgroups should be implemented to guide treatment tailoring and to allow a holistic and individual approach, instead of oversimplifying non-specific spinal complaints as one condition.
GOAL :
To evaluate the effectiveness of a patient tailored treatment (PTT) combined with individualized education, compared to (1) a non-patient tailored treatment (NPTT) consisting of a generalized exercise program with education and (2) a control group for (sub)acute (recurrent) nonspecific complaints.
- Conditions
- Neck Pain, Acute Pain, Rehabilitation, Physical Therapy Modalities
- Being tested
- patient-tailored therapy, Non-patient tailored therapy: generalized exercise program, Education
- Keywords
- stratified care, patient-tailored therapy, subacute
- Medical subject headings
- Neck Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-tailored therapyOther
The subjects in the PTT group will receive the individual tailored treatment program combining best evidence active and passive treatment strategies (manual therapy, individual exercises) in combination with education tailored to the individual situation of the patient and selected home exercises. 9 individual therapy sessions will be performed, in combination with 9 additional home exercise sessions.. NRS and NDI-scores will be monitored before every treatment. The therapist will register when the cut-off score of 30% NDI reduction is present in order to determine the evolution in pain/disability reduction. The importance of self-efficacy will be emphasized and tailored home-exercises will be monitored and adjusted every week.
Non-patient tailored therapy: generalized exercise programOther
The NPTT will receive an individual (hands-off) treatment, which includes an active neck exercise program, non-tailored education and non-tailored home exercises, according to a previously published program with good results.53 The sessions will be performed once a week under supervision (9 therapy sessions, standard exercise program) and once a week by the patient at home (9 home exercise sessions, standard exercise program).
EducationOther
Education considering neck pain information
| Study group | Role | What they receive |
|---|---|---|
| Patient-tailored treatment group | Experimental | Objectives \& approach: The subjects in the PTT group will receive the individual tailored treatment program combining best evidence active and passive treatment strategies (manual therapy, individual exercises) in combination with education tailored to the individual situation of the patient and selected home exercises. 9 individual therapy sessions will be performed, in combination with 9 additional home exercise sessions.. NRS and NDI-scores will be monitored before every treatment. The therapist will register when the cut-off score of 30% NDI reduction is present in order to determine the evolution in pain/disability reduction. The importance of self-efficacy will be emphasized and tailored home-exercises will be monitored and adjusted every week. Receives: Other: patient-tailored therapy; Other: Education |
| Non patient-tailored treatment group | Active comparator | Objectives \& approach: The NPTT will receive an individual (hands-off) treatment, which includes an active neck exercise program, non-tailored education and non-tailored home exercises, according to a previously published program with good results.53 The sessions will be performed once a week under supervision (9 therapy sessions, standard exercise program) and once a week by the patient at home (9 home exercise sessions, standard exercise program). Receives: Other: Non-patient tailored therapy: generalized exercise program; Other: Education |
| Control group | No intervention | The subjects randomized to the control group will not receive any intervention, if necessary medication use is permitted and will be monitored using the iMTAQ. Patients will be asked not to seek other treatment options (if possible). If this is not possible, patients will be considered lost to follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in painscores in the neck region, overall pain score
Numeric Rating Scale (score 0-10; 0=no pain; 10=worst pain)
Measured: Baseline, every supervised treatment (Week 1-9),follow up 3 weeks,3,6,12 months post treatment
Change in disability
Neck Disability Index (score0-50; 0=no disability; 50=maximal disability)
Measured: Baseline, every supervised treatment (9x), follow up 3 weeks,3,6,12 months post treatment
Secondary outcomes (3)
Change in Global Perceived Effect
Global Perceived Effect Scale (score:1-7; 1=a lot better, 7= a lot worse)
Measured: After 3,6 & 9 supervised treatments, follow up 3 weeks,follow up 3,6,12 months
Change in medical costs
institute for Medical Technology Assessment (iMTA): Medical Costs Questionnaire
Measured: At baseline, follow up 3 weeks,3,6,12 months post treatment
Change in productivity costs
institute for Medical Technology Assessment(iMTA): Productivity Costs Questionnaire
Measured: At baseline, follow up 3 weeks,3,6,12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Dec 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Cagnie, Principal investigator, UGent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182035
- Sponsor's protocol ID
- B670201941044
- Status last verified
- Apr 2024
- First submitted
- 12 Nov 2019
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chys M, De Meulemeester K, De Sloovere M, De Greef I, Dewitte V, Cagnie B. Evaluating the effectiveness of patient-tailored treatment for patients with non-specific (sub)acute neck pain. Musculoskelet Sci Pract. 2025 Feb;75:103235. doi: 10.1016/j.msksp.2024.103235. Epub 2024 Nov 25.
PubMed 39622101
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Patient-tailored Treatment Versus Non Patient-tailored Treatment in Patients With Acute and Subacute Idiopathic Neck Pain
- ClinicalTrials.gov ID
- NCT04182035
- Acronym / sponsor ID
- B670201941044
- Conditions
- Neck Pain, Acute Pain, Rehabilitation, Physical Therapy Modalities
- Keywords
- stratified care, patient-tailored therapy, subacute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Dec 2019 (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 purpose of the present study is to examine if a patient-tailored treatment program has a better effect on pain and disability than a non-patient tailored treatment or wait and see approach in patients with (sub)acute (recurrent) NSNP. A secondary goal is to evaluate the global perceived effect, treatment adherence, recurrence, work absenteeism and medication use. All interventional treatment arms will consist of a treatment part in a clinical practice setting, under supervision of a trained physiotherapist, and an educational intervention and will be compared to the control group.
Detailed description
Non-specific neck pain (NSNP) is a widespread health problems and a major cause of pain and disability. This condition is complex, disabling and has a heterogeneous presentation, which makes NSNP difficult to treat. Currently, the best evidence supports combining different forms of manual therapy (mobilizations, manipulations and manual muscle techniques), and exercises. Yet, identifying the most effective treatment characteristics and dosages remain challenging. Central in the debate about best practice management of NSNP and NSLBP is the efficacy of tailored versus generic (non-tailored) treatment. To date, sufficient evidence for the application of specific physiotherapy modalities or therapy aiming at specific NSNP subgroups is lacking. Although more research has already been conducted for the lumbar spine, there is an ongoing quest to identify relevant subgroups and provide patients with an assessment-driven targeted intervention to achieve meaningful and long-lasting changes.
Attempts have been made to identify relevant and homogeneous subgroups for patients with NSNP. Several classification systems have been proposed, based on (1) prognosis or (2) the underlying mechanism(s) driving the disorder: (2a) pain mechanisms, (2b) features of movement/posture/muscle activation , and (2c) pathology/diagnosis. The main goal of subgrouping patients is to enhance treatment efficiency. Nevertheless, a profound clinical reasoning process is necessary to identify clinically relevant subgroups. By identifying accurate and useful diagnostic criteria for NSNP and NSLBP, more informed decisions regarding the management of these conditions could be made.
Clinicians and researchers are hopeful that tailoring treatment to subgroups of patients may positively impact on patient outcomes and more efficient usage of health-care resources. For the lumbar spine, tailoring treatment to different subgroups is already present in literature. For example, in patients with pain provoked by postures/movements, tailoring treatment to modify specific features of posture/movement is effective and patients allocated to subgroups respond better to matched rather than unmatched interventions. Yet, other studies showed no additional benefit. Despite the growing interest for tailoring treatment for NSNP, the definition of tailored/stratified care is broadly used and interpretation is diverse. In order to determine best practice for the individual patient, tailoring the treatment should account for the multidimensional nature of non-specific spinal complaints and respect the individual characteristics of the patient within its subgroup. Additionally, it must take into account that patients may present with features of multiple subgroups or evolve through subgroups during treatments.
Previous studies on NSLBP already showed that targeting treatment can reduce costs and may improve outcomes when specific groups are compared. Unfortunately, at this moment, no conclusive high-quality evidence is present for its superiority. In addition to the lumbar spine, research on stratified care for NSNP is scarce compared to NSLBP research. Despite its major prevalence and socioeconomic consequences, no recommended or validated classification systems to stratify care for NSNP and to target specific subgroups are available. This suggests that the treatment decision in this heterogeneous group mostly depends on the clinical reasoning process, which is often incomplete in research on NSNP.
In order to evaluate the best practice for NSNP, a classification system based on a profound clinical reasoning process, identifying clinically relevant subgroups should be implemented to guide treatment tailoring and to allow a holistic and individual approach, instead of oversimplifying non-specific spinal complaints as one condition.
GOAL :
To evaluate the effectiveness of a patient tailored treatment (PTT) combined with individualized education, compared to (1) a non-patient tailored treatment (NPTT) consisting of a generalized exercise program with education and (2) a control group for (sub)acute (recurrent) nonspecific complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient-tailored treatment group | Experimental | Other: patient-tailored therapy, Other: EducationObjectives \& approach: The subjects in the PTT group will receive the individual tailored treatment program combining best evidence active and passive treatment strategies (manual therapy, individual exercises) in combination with education tailored to the individual situation of the patient and selected home exercises. 9 individual therapy sessions will be performed, in combination with 9 additional home exercise sessions.. NRS and NDI-scores will be monitored before every treatment. The therapist will register when the cut-off score of 30% NDI reduction is present in order to determine the evolution in pain/disability reduction. The importance of self-efficacy will be emphasized and tailored home-exercises will be monitored and adjusted every week. |
| Non patient-tailored treatment group | Active comparator | Other: Non-patient tailored therapy: generalized exercise program, Other: EducationObjectives \& approach: The NPTT will receive an individual (hands-off) treatment, which includes an active neck exercise program, non-tailored education and non-tailored home exercises, according to a previously published program with good results.53 The sessions will be performed once a week under supervision (9 therapy sessions, standard exercise program) and once a week by the patient at home (9 home exercise sessions, standard exercise program). |
| Control group | No intervention | –The subjects randomized to the control group will not receive any intervention, if necessary medication use is permitted and will be monitored using the iMTAQ. Patients will be asked not to seek other treatment options (if possible). If this is not possible, patients will be considered lost to follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-specific neck pain, pain located in the cervico-thoracic and posterior shoulder region; without dominant arm pain.
- NDI scores score ≥10 % (more than no disability) and ≤68 % (less than complete disability)
- (Sub)acute complaints: <3 months
- Recurrent complaints but no neck pain episode the previous 3 months.
- Mean pain intensity scores: NRS > 3/10
Key exclusion criteria (12 listed)
- Structural pathology, confirmed by imaging (disk herniation, nerve root compression, radiculopathy, severe rheumatoid diseases, fractures, traumatic alterations…) Shoulder pathology, vestibular pathology.
- Risk stratification: Startback tool for neck pain: high risk group
- BMI > 30 kg/m²
- Other cardiovascular/metabolic/systemic/ neurological diseases, fibromyalgia or chronic fatigue syndrome
- Psychiatric illnesses, history of depression, serious catastrophizing thoughts and/or low treatment expectations.[52]
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 |
|---|---|---|
| patient-tailored therapyThe subjects in the PTT group will receive the individual tailored treatment program combining best evidence active and passive treatment strategies (manual therapy, individual exercises) in combination with education tailored to the individual situation of the patient and selected home exercises. 9 individual therapy sessions will be performed, in combination with 9 additional home exercise sessions.. NRS and NDI-scores will be monitored before every treatment. The therapist will register when the cut-off score of 30% NDI reduction is present in order to determine the evolution in pain/disability reduction. The importance of self-efficacy will be emphasized and tailored home-exercises will be monitored and adjusted every week. | Other | Patient-tailored treatment group |
| Non-patient tailored therapy: generalized exercise programThe NPTT will receive an individual (hands-off) treatment, which includes an active neck exercise program, non-tailored education and non-tailored home exercises, according to a previously published program with good results.53 The sessions will be performed once a week under supervision (9 therapy sessions, standard exercise program) and once a week by the patient at home (9 home exercise sessions, standard exercise program). | Other | Non patient-tailored treatment group |
| EducationEducation considering neck pain information | Other | Non patient-tailored treatment group, Patient-tailored treatment group |
Primary outcome
Change in painscores in the neck region, overall pain score
Time frame: Baseline, every supervised treatment (Week 1-9),follow up 3 weeks,3,6,12 months post treatment
Numeric Rating Scale (score 0-10; 0=no pain; 10=worst pain)
Change in disability
Time frame: Baseline, every supervised treatment (9x), follow up 3 weeks,3,6,12 months post treatment
Neck Disability Index (score0-50; 0=no disability; 50=maximal disability)
3 secondary outcomes
Change in Global Perceived Effect
Time frame: After 3,6 & 9 supervised treatments, follow up 3 weeks,follow up 3,6,12 months
Change in medical costs
Time frame: At baseline, follow up 3 weeks,3,6,12 months post treatment
Change in productivity costs
Time frame: At baseline, follow up 3 weeks,3,6,12 months post treatment
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 29 Apr 2024.
- Derived from this study: PubMed 39622101Chys M, De Meulemeester K, De Sloovere M, De Greef I, Dewitte V, Cagnie B. Evaluating the effectiveness of patient-tailored treatment for patients with non-specific (sub)acute neck pain. Musculoskelet Sci Pract. 2025 Feb;75:103235. doi: 10.1016/j.msksp.2024.103235. Epub 2024 Nov 25.
- Individual participant dataSharing planned: No
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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.
Barbara Cagnie principal investigator
UGent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient-tailored therapy, Non-patient tailored therapy: generalized exercise program and Education in people with Neck Pain and Acute Pain, run by University Ghent at 1 site in Belgium.
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 12 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 29 Apr 2024. 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 Belgium. 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 painscores in the neck region, overall pain score (time frame: Baseline, every supervised treatment (Week 1-9),follow up 3 weeks,3,6,12 months post treatment). 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?
On the ClinicalTrials.gov record for NCT04182035, which also lists 1 linked publication.
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 29 Apr 2024.