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Clinical Trials/NCT03562338
NCT03562338
Unknown
Not Applicable

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

Universidade Nova de Lisboa0 sites80 target enrollmentJune 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Nonspecific Neck Pain
Sponsor
Universidade Nova de Lisboa
Enrollment
80
Primary Endpoint
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
February 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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 Outcomes

  • Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks(3 weeks)
  • Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks(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(Follow-up 3 months)

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