Clinical Effects in Cervical Spinal Mobilization and Oscillation Mobilization in Neck Pain
Primary Purpose
Manual Therapy, Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spine Mobilizations
Vertebral Resonant Oscillation
Sponsored by
About this trial
This is an interventional treatment trial for Manual Therapy focused on measuring mobilization, resonant oscillation
Eligibility Criteria
Inclusion Criteria:
- neck pain symptoms of mechanical nature
- age from 18 to 60 years
- bilateral symptoms
- symptoms for at least 3 month of duration
Exclusion Criteria:
- whiplash injury
- previous spine surgery
- diagnosis of cervical radiculopathy or myelopathy
- having undergone any physical therapy intervention in the previous 6 month
- pregnancy
Sites / Locations
- Universidad Rey Juan Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Spine Mobilizations
Vertebral Resonant Oscillation (POLD method)
Arm Description
Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000.
The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.
Outcomes
Primary Outcome Measures
Changes in pain intensity before and after the intervention
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of neck pain
Secondary Outcome Measures
Changes in disability before and after the intervention
Neck Pain Disability Index (NDI)
Full Information
NCT ID
NCT03149614
First Posted
May 9, 2017
Last Updated
October 28, 2018
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT03149614
Brief Title
Clinical Effects in Cervical Spinal Mobilization and Oscillation Mobilization in Neck Pain
Official Title
Clinical Effects in Cervical Spinal Mobilization Versus Resonant Oscillation Mobilization (POLD) in Neck Pain. A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
October 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to compare the clinical effects of spinal mobilization versus vertebral resonant oscillation (POLD) in patients with bilateral mechanical neck pain on pain sensitivity and neck pain intensity.
Detailed Description
The clinical practice guidelines for manual therapy management the neck pain including the spine mobilization.
The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.
The spinal mobilizations has a posterior-anterior vertebral movement for spinous process, described by Maitland 2000.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Manual Therapy, Neck Pain
Keywords
mobilization, resonant oscillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spine Mobilizations
Arm Type
Active Comparator
Arm Description
Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000.
Arm Title
Vertebral Resonant Oscillation (POLD method)
Arm Type
Experimental
Arm Description
The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.
Intervention Type
Other
Intervention Name(s)
Spine Mobilizations
Intervention Description
Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000
Intervention Type
Other
Intervention Name(s)
Vertebral Resonant Oscillation
Intervention Description
The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens ; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to "neutral zone" to described by Panjabi 1992.
Primary Outcome Measure Information:
Title
Changes in pain intensity before and after the intervention
Description
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of neck pain
Time Frame
Baseline, one week after the last session, 1 months and 3 months after the last session.
Secondary Outcome Measure Information:
Title
Changes in disability before and after the intervention
Description
Neck Pain Disability Index (NDI)
Time Frame
Baseline, one week after the last session, 1 months and 3 months after the last session.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
neck pain symptoms of mechanical nature
age from 18 to 60 years
bilateral symptoms
symptoms for at least 3 month of duration
Exclusion Criteria:
whiplash injury
previous spine surgery
diagnosis of cervical radiculopathy or myelopathy
having undergone any physical therapy intervention in the previous 6 month
pregnancy
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Madrid
ZIP/Postal Code
282922
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Effects in Cervical Spinal Mobilization and Oscillation Mobilization in Neck Pain
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