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

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: NCT03562338
• Other study ID #: NOVA.MS|FCM-UNL
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: February 2019

Study information

• Verified date: June 2018
• Source: Universidade Nova de Lisboa
• Contact: Lúcia Domingues
• 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• 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)
Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week.
• Usual Care (Physiotherapy Intervention)
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	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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