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

Sponsor

Universidade Nova de Lisboa (Other)

Overall Status

Unknown status

CT.gov ID

NCT03562338

Collaborator

(none)

Enrollment

Arms

7.7

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Nonspecific Neck Pain	Other: Manual Therapy and Exercise (Physiotherapy Intervention) Other: Usual Care (Physiotherapy Intervention)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Screening

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

Anticipated Study Start Date :

Jun 11, 2018

Anticipated Primary Completion Date :

Feb 1, 2019

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Manual Therapy and Exercise	Other: Manual Therapy and Exercise (Physiotherapy Intervention) Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week.
Active Comparator: Usual Care	Other: Usual Care (Physiotherapy Intervention) Participants in this group will receive usual care in physiotherapy during the 6-weeks period.

Arm

Intervention/Treatment

Experimental: Manual Therapy and Exercise

Other: Manual Therapy and Exercise (Physiotherapy Intervention)

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

Active Comparator: Usual Care

Other: Usual Care (Physiotherapy Intervention)

Participants in this group will receive usual care in physiotherapy during the 6-weeks period.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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