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

Sponsor

Universidad Rey Juan Carlos (Other)

Overall Status

Completed

CT.gov ID

NCT03149614

Collaborator

(none)

Enrollment

Location

Arms

17.5

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Manual Therapy Neck Pain	Other: Spine Mobilizations Other: Vertebral Resonant Oscillation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical Effects in Cervical Spinal Mobilization Versus Resonant Oscillation Mobilization (POLD) in Neck Pain. A Randomized Clinical Trial.

Actual Study Start Date :

May 10, 2017

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Oct 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spine Mobilizations Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000.	Other: Spine Mobilizations Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000
Experimental: Vertebral Resonant Oscillation (POLD method) 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.	Other: Vertebral Resonant Oscillation 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.

Arm

Intervention/Treatment

Active Comparator: Spine Mobilizations

Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000.

Other: Spine Mobilizations

Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000

Experimental: Vertebral Resonant Oscillation (POLD method)

Other: Vertebral Resonant Oscillation

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.

Outcome Measures

Primary Outcome Measures

Changes in pain intensity before and after the intervention [Baseline, one week after the last session, 1 months and 3 months after the last session.]
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 [Baseline, one week after the last session, 1 months and 3 months after the last session.]
Neck Pain Disability Index (NDI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Rey Juan Carlos	Madrid		Spain	282922

Sponsors and Collaborators

Universidad Rey Juan Carlos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jaime Salom Moreno, PT, PhD, Universidad Rey Juan Carlos

ClinicalTrials.gov Identifier:

NCT03149614

Other Study ID Numbers:

URJC201701

First Posted:

May 11, 2017

Last Update Posted:

Oct 31, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jaime Salom Moreno, PT, PhD, Universidad Rey Juan Carlos

mobilization

resonant oscillation

Additional relevant MeSH terms:

Neck Pain

Study Results

No Results Posted as of Oct 31, 2018