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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Nonspecific Neck Pain
• Intervention / Treatment: Other: Manual Therapy and Exercise (Physiotherapy Intervention); Other: Usual Care (Physiotherapy Intervention)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Other: Usual Care (Physiotherapy Intervention); Participants in this group will receive usual care in physiotherapy during the 6-weeks period.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 weeks
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)	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	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)	Follow-up 3 months

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa
• Investigators: Principal Investigator: Lúcia Domingues, Nova Medical School | Faculdade de Ciências Médicas - Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (Anticipated): June 11, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: rehabilitation; predictive model; pain intensity; disability; chronic nonspecific neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: NOVA.MS|FCM-UNL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No