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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • Marjolein Chys

    Ichtegem, België, 8480

Other trials in Belgium

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.

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 groups in NCT04182035
Study groupRoleWhat they receive
Patient-tailored treatment groupExperimentalObjectives \& 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 groupActive comparatorObjectives \& 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 groupNo interventionThe 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted2 Dec 2019
  2. Study start1 Dec 2019
  3. Primary completion31 Jan 2024
  4. Study completion31 Jan 2024

Resources

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)
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

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.

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