Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise
Primary Purpose
Chronic Nonspecific Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual Therapy and Exercise (Physiotherapy Intervention)
Usual Care (Physiotherapy Intervention)
Sponsored by
About this trial
This is an interventional screening trial for Chronic Nonspecific Neck Pain focused on measuring chronic nonspecific neck pain, disability, predictive model, rehabilitation, pain intensity
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manual Therapy and Exercise
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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).
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).
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).
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).
Secondary Outcome Measures
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)
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)
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)
Full Information
NCT ID
NCT03562338
First Posted
May 24, 2018
Last Updated
June 18, 2018
Sponsor
Universidade Nova de Lisboa
1. Study Identification
Unique Protocol Identification Number
NCT03562338
Brief Title
Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2018 (Anticipated)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Nova de Lisboa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Neck Pain
Keywords
chronic nonspecific neck pain, disability, predictive model, rehabilitation, pain intensity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy and Exercise
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Exercise (Physiotherapy Intervention)
Intervention Description
Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week.
Intervention Type
Other
Intervention Name(s)
Usual Care (Physiotherapy Intervention)
Intervention Description
Participants in this group will receive usual care in physiotherapy during the 6-weeks period.
Primary Outcome Measure Information:
Title
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 3 weeks.
Description
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).
Time Frame
3 weeks
Title
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at 6 weeks.
Description
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).
Time Frame
6 weeks
Title
Change from baseline in Neck Pain Intensity as measured by the Numeric pain rating scale (NRPS) at follow-up 3 months.
Description
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).
Time Frame
Follow-up 3 months
Title
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 3 weeks.
Description
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).
Time Frame
3 weeks
Title
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at 6 weeks.
Description
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).
Time Frame
6 weeks
Title
Change from baseline in Neck Disability as measured by the Neck Disability Index (NDI) at follow-up 3 months.
Description
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).
Time Frame
Follow-up 3 months
Secondary Outcome Measure Information:
Title
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 3 weeks
Description
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)
Time Frame
3 weeks
Title
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at 6 weeks
Description
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)
Time Frame
6 weeks
Title
Clinical Important Treatment response in global perceived recovery as measured by Patient's Global Impression of Change Scale at follow-up 3 months
Description
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)
Time Frame
Follow-up 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lúcia Domingues
Phone
00351967648456
Email
lucia.domingues@nms.unl.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lúcia Domingues
Organizational Affiliation
NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Predictive Model of Recovery in Patients With Chronic Nonspecific Neck Pain Undergoing Manual Therapy and Exercise
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