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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
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Manual Therapy focused on measuring mobilization, resonant oscillation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 9, 2017
Last Updated
October 28, 2018
Sponsor
Universidad Rey Juan Carlos
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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

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Clinical Effects in Cervical Spinal Mobilization and Oscillation Mobilization in Neck Pain

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