Back to resultsActive Intervention for Patients With Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Active exercising
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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.
Sites / Locations
- Department of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active intervention
Control group
Arm Description
Patients will be included in an active intervention.
Patients in the control group will not receive any intervention
Outcomes
Primary Outcome Measures
Changes in number of active trigger points
Baseline, 4 weeks
Secondary Outcome Measures
Severity of pain
Baseline, 4 weeks
Functionality
Baseline, 4 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03987516
Brief Title
Active Intervention for Patients With Neck Pain
Official Title
Effects of an Active Program in Patients With Chronic Neck Pain: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
August 11, 2019 (Actual)
Study Completion Date
September 11, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active intervention
Arm Type
Experimental
Arm Description
Patients will be included in an active intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group will not receive any intervention
Intervention Type
Other
Intervention Name(s)
Active exercising
Intervention Description
Patients allocated to the experimental group were included in an active exercising program adapted to each patient
Primary Outcome Measure Information:
Title
Changes in number of active trigger points
Description
Baseline, 4 weeks
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.
Secondary Outcome Measure Information:
Title
Severity of pain
Description
Baseline, 4 weeks
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.
Title
Functionality
Description
Baseline, 4 weeks
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958248035
Email
cvalenza@ugr.es
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Email
cvalenza@ugr.es
12. IPD Sharing Statement
Learn more about this trial
Active Intervention for Patients With Neck Pain
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