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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
Universidade Nova de Lisboa
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 24, 2018
    Last Updated
    June 18, 2018
    Sponsor
    Universidade Nova de Lisboa
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    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

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

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