Individual Responder Analysis of the Effectiveness of Manual Therapy and Exercise Versus Usual Care in Patients With Chronic Nonspecific Neck Pain

Study Overview
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Brief Summary
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The aim of this study is to compare the effectiveness of a combined intervention of manual therapy and exercise versus usual care, on pain intensity, disability, and global perceived recovery, in patients with chronic nonspecific neck pain.

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: Treatment
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>* Experimental group: Manual Therapy and Exercise Participants in this group will receive a 6-weeks program of mobilization and progressive exercise programme for the neck flexors, 2 times a week.<br>|
| Active Comparator: Usual Care<br> | Other: Usual Care (Physiotherapy Intervention)<br>* Active Comparator: Usual Care 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 |
| --- | --- | --- |
| Neck Pain Intensity | Measured using a Numeric Pain Rating Scale (range: 0 - 10 points) | Baseline | 
| Neck Pain Intensity | Measured using a Numeric Pain Rating Scale (range: 0 - 10 points) | 3 weeks | 
| Neck Pain Intensity | Measured using a Numeric Pain Rating Scale (range: 0 - 10 points) | 6 weeks | 
| Neck Pain Intensity | Measured using a Numeric Pain Rating Scale (range: 0 - 10 points) | Follow-up 3 months | 
| Neck Disability | Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability) | Baseline | 
| Neck Disability | Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability) | 3 weeks | 
| Neck Disability | Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability) | 6 weeks | 
| Neck Disability | Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability) | Follow-up 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Global Perceived Recovery | Measured using Patient Global Impression of Change Scale to quantify a patient's global improvement over time. | Change from baseline of the global perceived recovery at 3 weeks; 6 weeks; 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, manual therapy, exercise