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

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ClinicalTrials.gov Identifier: NCT03560947
Recruitment Status : Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade Nova de Lisboa

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Nonspecific Neck Pain Other: Manual Therapy and Exercise (Physiotherapy Intervention) Other: Usual Care (Physiotherapy Intervention) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 20, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Neck Pain Intensity [ Time Frame: Baseline ]
    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

  2. Neck Pain Intensity [ Time Frame: 3 weeks ]
    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

  3. Neck Pain Intensity [ Time Frame: 6 weeks ]
    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

  4. Neck Pain Intensity [ Time Frame: Follow-up 3 months ]
    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

  5. Neck Disability [ Time Frame: Baseline ]
    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

  6. Neck Disability [ Time Frame: 3 weeks ]
    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

  7. Neck Disability [ Time Frame: 6 weeks ]
    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

  8. Neck Disability [ Time Frame: Follow-up 3 months ]
    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)


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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560947


Contacts
Contact: Lúcia Domingues, M.Sc. 00351967648456 lucia.domingues@nms.unl.pt
Contact: Lúcia Domingues, M.Sc. 00351967648456

Sponsors and Collaborators
Universidade Nova de Lisboa
Investigators
Principal Investigator: Lúcia Domingues, M.Sc. Nova Medical School | Faculdade de Ciências Médicas - Universidade Nova de Lisboa

Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT03560947     History of Changes
Other Study ID Numbers: NMS|FCM-UNL
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidade Nova de Lisboa:
chronic nonspecific neck pain
exercise
manual therapy

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms