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

Not Applicable
Conditions
Chronic Nonspecific Neck Pain
Registration Number
NCT03562338
Lead Sponsor
Universidade Nova de Lisboa
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.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).

Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at follow-up 3 months.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).

Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at follow-up 3 months.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).

Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 6 weeks.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).

Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 3 weeks.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).

Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 6 weeks.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).

Secondary Outcome Measures
NameTimeMethod
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks3 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)

Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks6 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)

Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at follow-up 3 monthsFollow-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)

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