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出境医 / 临床实验 / Active Intervention for Patients With Neck Pain

Active Intervention for Patients With Neck Pain

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.

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.
Study Design
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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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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:

  • 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.
Contacts and Locations

Contacts
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Contact: Marie Carmen Valenza, PhD 958248035 cvalenza@ugr.es

Locations
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Spain
Department of Physical Therapy Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD       cvalenza@ugr.es   
Sponsors and Collaborators
Universidad de Granada
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE June 11, 2019
Actual Primary Completion Date August 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019) 		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 ]
Baseline, 4 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Severity of pain [ Time Frame: Changes from baseline to 4 weeks in the severity of pain assessed using the Brief Pain Inventory ]
    Baseline, 4 weeks
  • Functionality [ Time Frame: Changes from baseline to 4 weeks on functionality assessed using the Neck Outcome Score. ]
    Baseline, 4 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Active Intervention for Patients With Neck Pain
Official Title  ICMJE Effects of an Active Program in Patients With Chronic Neck Pain: a Randomized Controlled Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE Other: Active exercising
Patients allocated to the experimental group were included in an active exercising program adapted to each patient
Study Arms  ICMJE
  • Experimental: Active intervention
    Patients will be included in an active intervention.
    Intervention: Other: Active exercising
  • No Intervention: Control group
    Patients in the control group will not receive any intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 11, 2019
Actual Primary Completion Date August 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Carmen Valenza, PhD 958248035 cvalenza@ugr.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987516
Other Study ID Numbers  ICMJE DF0081UG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marie Carmen Valenza, Universidad de Granada
Study Sponsor  ICMJE Universidad de Granada
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad de Granada
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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