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Individual Responder Analysis of the Effectiveness of Manual Therapy and Exercise Versus Usual Care in Patients With Chronic Nonspecific Neck Pain

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)

About this trial

This is an interventional treatment trial for Chronic Nonspecific Neck Pain focused on measuring chronic nonspecific neck pain, exercise, manual therapy

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

Neck Pain Intensity

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Neck Pain Intensity

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Neck Pain Intensity

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Neck Pain Intensity

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Neck Disability

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Neck Disability

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Neck Disability

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Neck Disability

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Secondary Outcome Measures

Neck Global Perceived Recovery

Measured using Patient Global Impression of Change Scale to quantify a patient's global improvement over time.

Full Information

NCT ID

NCT03560947

First Posted

May 23, 2018

Last Updated

June 15, 2018

Sponsor

Universidade Nova de Lisboa

1. Study Identification

Unique Protocol Identification Number

NCT03560947

Brief Title

Individual Responder Analysis of the Effectiveness of Manual Therapy and Exercise Versus Usual Care in Patients With Chronic Nonspecific Neck Pain

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 20, 2018 (Anticipated)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to compare the effectiveness of a combined intervention of manual therapy and exercise versus usual care, on pain intensity, disability, and global perceived recovery, in patients with chronic nonspecific neck pain.

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, exercise, manual therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

46 (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

Experimental group: Manual Therapy and Exercise Participants in this group will receive a 6-weeks program of mobilization and progressive exercise programme for the neck flexors, 2 times a week.

Intervention Type

Other

Intervention Name(s)

Usual Care (Physiotherapy Intervention)

Intervention Description

Active Comparator: Usual Care Participants in this group will receive usual care in physiotherapy during the 6-weeks period.

Primary Outcome Measure Information:

Title

Neck Pain Intensity

Description

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Time Frame

Baseline

Title

Neck Pain Intensity

Description

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Time Frame

3 weeks

Title

Neck Pain Intensity

Description

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Time Frame

6 weeks

Title

Neck Pain Intensity

Description

Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

Time Frame

Follow-up 3 months

Title

Neck Disability

Description

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Time Frame

Baseline

Title

Neck Disability

Description

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Time Frame

3 weeks

Title

Neck Disability

Description

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Time Frame

6 weeks

Title

Neck Disability

Description

Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

Time Frame

Follow-up 3 months

Secondary Outcome Measure Information:

Title

Neck Global Perceived Recovery

Description

Measured using Patient Global Impression of Change Scale to quantify a patient's global improvement over time.

Time Frame

Change from baseline of the global perceived recovery at 3 weeks; 6 weeks; 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

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, M.Sc.

Phone

00351967648456

lucia.domingues@nms.unl.pt

First Name & Middle Initial & Last Name or Official Title & Degree

Lúcia Domingues, M.Sc.

Phone

00351967648456

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lúcia Domingues, M.Sc.

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

Individual Responder Analysis of the Effectiveness of Manual Therapy and Exercise Versus Usual Care in Patients With Chronic Nonspecific Neck Pain

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