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

Chronic Nonspecific Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03560947
• Other study ID #: NMS|FCM-UNL
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: Universidade Nova de Lisboa
• Contact: Lúcia Domingues, M.Sc.
• Phone: 00351967648456
• Email: lucia.domingues[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Nonspecific Neck Pain
• Neck Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa

Outcome

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