Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise

Study Overview
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Brief Summary
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The aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care.

Official Title
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Modelo Preditivo Para os Resultados de Sucesso Com um Programa Combinado de Terapia Manual e exercício em indivíduos Com Dor Cervical crónica de Origem não-especifica

Conditions
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Chronic Nonspecific Neck Pain

Intervention / Treatment
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* Other: Manual Therapy and Exercise (Physiotherapy Intervention)
* Other: Usual Care (Physiotherapy Intervention)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis; Adults between 18 and 65 years of age and literate in Portuguese; Exclusion Criteria: History of cervical trauma and/or history of surgery in the prior 6 months; Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases; Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy and Exercise<br> | Other: Manual Therapy and Exercise (Physiotherapy Intervention)<br>* Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week.<br>|
| Active Comparator: Usual Care<br> | Other: Usual Care (Physiotherapy Intervention)<br>* Participants in this group will receive usual care in physiotherapy during the 6-weeks period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks. | The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points). | 3 weeks | 
| Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 6 weeks. | The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points). | 6 weeks | 
| Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at follow-up 3 months. | The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥2 point in NRPS (range: 0 - 10 points). | Follow-up 3 months | 
| Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 3 weeks. | The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability). | 3 weeks | 
| Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 6 weeks. | The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability). | 6 weeks | 
| Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at follow-up 3 months. | The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of ≥27% in NDI (range: 0-50 and higher scores are indicative of more disability). | Follow-up 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks | The clinically Important treatment response in global perceived recovery was defined as a value of ≥5 in Patient's Global Impression of Change Scale (range: 1-7 Likert Scale) | 3 weeks | 
| Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks | The clinically Important treatment response in global perceived recovery was defined as a value of ≥5 in Patient's Global Impression of Change Scale (range: 1-7 Likert Scale) | 6 weeks | 
| Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at follow-up 3 months | The clinically Important treatment response in global perceived recovery was defined as a value of ≥5 in Patient's Global Impression of Change Scale (range: 1-7 Likert Scale) | Follow-up 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic nonspecific neck pain, disability, predictive model, rehabilitation, pain intensity