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Active Intervention for Patients With Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03987516
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Brief Summary:
Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. More than 80 % of individuals experience neck pain and neck associated disorders. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

Condition or disease Intervention/treatment Phase
Neck Pain Other: Active exercising Not Applicable

Detailed Description:
While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. The optimal physiotherapy intervention is currently unclear. Consequently, more research in this area combining different techniques in patients with a specific clinical profile is needed. It has been previously shown that participants prefer self-care measures for the management of neck pain. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Active Program in Patients With Chronic Neck Pain: a Randomized Controlled Trial.
Actual Study Start Date : June 11, 2019
Actual Primary Completion Date : August 11, 2019
Estimated Study Completion Date : September 11, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active intervention
Patients will be included in an active intervention.
Other: Active exercising
Patients allocated to the experimental group were included in an active exercising program adapted to each patient

No Intervention: Control group
Patients in the control group will not receive any intervention

Primary Outcome Measures :
  1. Changes in number of active trigger points [ Time Frame: Changes from baseline to 4 weeks in the number of active trigger points assessed by palpation. The percentage of active trigger points is obtained. ]
    Baseline, 4 weeks

Secondary Outcome Measures :
  1. Severity of pain [ Time Frame: Changes from baseline to 4 weeks in the severity of pain assessed using the Brief Pain Inventory. The severity and the interference of pain with daily life subscales were included. Score is the sum of the items divided by the number of items. ]
    Baseline, 4 weeks

  2. Functionality [ Time Frame: Changes from baseline to 4 weeks on functionality assessed using the Neck Outcome Score.Symptoms, sleep disturbance, every day activity and pain and participation in everyday life subscales were included. They Ranged from 0 to 100 (no simptoms). ]
    Baseline, 4 weeks

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • To suffer from chronic neck pain (at least 3 months' duration)
  • Neck pain of at least 3 on a visual analogue scale.
  • Participants' symptoms should be at least partly related to increased nerve mechanosensitivity in the neck and upper limb confirmed by the reproduction of participants' symptoms by median nerve upper-limb neurodynamic test.

Exclusion Criteria:

  • Whiplash related neck pain.
  • Previous cervical surgical intervention.
  • Cognitive impairments which prevent them to follow instructions.
  • Visual or acoustic limitations.

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 identifier (NCT number): NCT03987516

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Contact: Marie Carmen Valenza, PhD 958248035

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Department of Physical Therapy Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD   
Sponsors and Collaborators
Universidad de Granada
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Responsible Party: Marie Carmen Valenza, Principal Investigator, Universidad de Granada Identifier: NCT03987516    
Other Study ID Numbers: DF0081UG
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neck Pain
Neurologic Manifestations
Signs and Symptoms