The Effectiveness of Patient-tailored Treatment in Patients With (Sub)Acute Neck Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain; Rehabilitation; Acute Pain; Physical Therapy Modalities
• Intervention / Treatment: Other: patient-tailored therapy; Other: Education; Other: Non-patient tailored therapy: generalized exercise program

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marjolein Chys; Phone Number: 0491439513; Email: Marjolein.Chys@Ugent.be

Study Locations

• Belgium
  • België
    • Ichtegem, België, Belgium, 8480
      • Recruiting
      • Marjolein Chys
      • Contact: Marjolein Chys; Phone Number: 0491439513; Email: Marjolein.Chys@Ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-tailored treatment group; 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.	Other: patient-tailored therapy; 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.; Other: Education; Education considering neck pain information
Active Comparator: Non patient-tailored treatment group; 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).	Other: Education; Education considering neck pain information; Other: Non-patient tailored therapy: generalized exercise program; 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).
No Intervention: Control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in painscores in the neck region, overall pain score	Numeric Rating Scale (score 0-10; 0=no pain; 10=worst pain)	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)	Baseline, every supervised treatment (9x), follow up 3 weeks,3,6,12 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Perceived Effect	Global Perceived Effect Scale (score:1-7; 1=a lot better, 7= a lot worse)	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	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	At baseline, follow up 3 weeks,3,6,12 months post treatment

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Barbara Cagnie, UGent

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: subacute; stratified care; patient-tailored therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Acute Pain
• Other Study ID Numbers: B670201941044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No