Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise
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
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedStudy Start
First participant enrolled
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedJune 19, 2018
June 1, 2018
8 months
May 24, 2018
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (3)
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
Study Arms (2)
Manual Therapy and Exercise
EXPERIMENTALUsual Care
ACTIVE COMPARATORInterventions
Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week.
Participants in this group will receive usual care in physiotherapy during the 6-weeks period.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lúcia Domingues
NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 19, 2018
Study Start
June 11, 2018
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
June 19, 2018
Record last verified: 2018-06