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

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 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.

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): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lúcia Domingues, M.Sc.; Phone Number: 00351967648456; Email: lucia.domingues@nms.unl.pt
• Study Contact Backup: Name: Lúcia Domingues, M.Sc.; Phone Number: 00351967648456

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 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: Treatment
• 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); Active Comparator: Usual Care 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Pain Intensity	Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)	Baseline
Neck Pain Intensity	Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)	3 weeks
Neck Pain Intensity	Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)	6 weeks
Neck Pain Intensity	Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)	Follow-up 3 months
Neck Disability	Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)	Baseline
Neck Disability	Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)	3 weeks
Neck Disability	Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)	6 weeks
Neck Disability	Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)	Follow-up 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Global Perceived Recovery	Measured using Patient Global Impression of Change Scale to quantify a patient's global improvement over time.	Change from baseline of the global perceived recovery at 3 weeks; 6 weeks; Follow-up 3 months

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa
• Investigators: Principal Investigator: Lúcia Domingues, M.Sc., NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: exercise; manual therapy; chronic nonspecific neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: NMS|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