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Vertical Oscillatory Pressure and Sustained Natural Apophyseal Glides in ow Back Pain (VOP&SNAG)

Primary Purpose

Non Specific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Vertical Oscillatory Pressure (VOP)
Sponsored by
Obafemi Awolowo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Specific Low Back Pain focused on measuring Low back pain,, Vertical Oscillatory Pressure,, Sustained Natural Apophzeal Glide,, Pain-Biomakers, Health Related Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with non specific low back pain of at least 3 months duration age of 18-75 years No history of hospitalization in the last 12 months Exclusion Criteria: No history of trauma organic diseases No mental disorderliness

Sites / Locations

  • Obafemi Awolowo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Verical Oscillatory Pressure (VOP)

Sustained Natural Apophyzeal Glides

Arm Description

Vertical Oscillatory Pressure (VOP) will be administered with the patient lying prone on a couch. The researcher will place the thumb reinforced with the other thumb on the implicated lumbar vertebra, then apply pressure posterior anteriorly on the spinous process and oscillate for a maximum of 60 seconds. This will be done on each patient in this group twice a week for 6 weeks after an initial assessment both subjective and objective (Egwu et al, 2007).

Participant in this group will undergo SNAG technique on lumbar vertebra with active spinal movement according to Mulligan, (2004). Participants will be in a sitting position on the edge of the couch while both feet will be on a footrest. A stabilization belt will be used around the patient's waist and the therapist's hips and the researcher standing behind the patient well supported with stabilization belt. The researcher places one thumb or hypothenar eminence (pisiform bone) reinforced by the other on the spinous process of the implicated lumbar vertebra and then apply pressure posterior-anteriorly on the spinous process, the pressure will be sustained and the patient concurrently performs active spinal movement. SNAGS will be applied with 3 repetitions on the first day and 10 repetitions from next visit. SNAG will be used twice a week for 6 weeks.

Outcomes

Primary Outcome Measures

Visual analogue scale
Pain perception: Which is measured by Visual Analogue Scale . This is an instrument that measure the pain perception of the patients. The minimum is 0, which indicated no pain and the maximum is 10 which described excruciating pain

Secondary Outcome Measures

Interleuking 6
Concentration of pain factors in the blood. It is an chemical in the blood that determines how individuals perceive pain in the body. The minimum is 30 which indicate no pain and the maximum could be 250 which indicate extreme pain

Full Information

First Posted
October 31, 2022
Last Updated
November 4, 2022
Sponsor
Obafemi Awolowo University
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1. Study Identification

Unique Protocol Identification Number
NCT05612308
Brief Title
Vertical Oscillatory Pressure and Sustained Natural Apophyseal Glides in ow Back Pain
Acronym
VOP&SNAG
Official Title
Effects of Vertical Oscillatory Pressure and Sustained Natural Apophyseal Glides on Pain- Biomakers, Selected Clinical and Psychosocial Variables in Patients With Mechanical Low- Back -Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
September 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obafemi Awolowo University

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
Among different spinal manual therapies, which have been reported to be effective in the management of LBP are Sustained Natural Apophyseal Glide (SNAGS) and Vertical Oscillatory Pressure (VOP) . Vertical oscillatory pressure is a derivative of manipulative therapy whereby a gentle vertical manipulative oscillation is applied on spinal vertebrae and has been noted to be effective in management of low back pain . On the contrary, the SNAGS is a manipulative technique that is commonly used in the western countries and found to be effective in reducing pain and disability in the management of mechanical LBP . However, there are limited studies comparing the effects of SNAG and VOP on clinical and psychosocial variables in patients with mechanical LBP in Nigeria. Hence, this study aims at investigating the effects of Nwugarian VOP and SNAG techniques on selected clinical and psychosocial variables in patients with mechanical LBP.
Detailed Description
Low back pain and the attendant disabilities have been on the increase in Africa and its burden is more in countries with longer life expectancy . The menace of the condition includes high level of disability, producing significant restrictions on usual activity and participation, such as ability to work . Contrary to general belief, LBP is not a problem that always resolves by itself, recurrences are usual and the course is varying in different circumstances . While emerging evidence and advocacy by Physiotherapy Associations favours active treatment for long-term LBP, however, spinal manipulation remains an important option for LBP that will or not resolve with active and self-care. Spinal manipulation has been reported to produce significant benefits within a short period , may be more and faster than expected improvements with active therapies . Further, while there is increasing advocacy for active management of LBP, many patients are not well suited or positioned to treat themselves, hence may require experts' management. Sustained Natural Apophyseal Glide (SNAGS) is a manipulative technique that is commonly used in the western countries and found to be effective in reducing pain and disability in the management of mechanical LBP . In another study by Shabana et al., on the comparative effect of SNAGS and Maitland's mobilization in chronic LBP, better improvement was observed in SNAGS group than in Maitland's. however, it is not commonly used in the Nigerian context. On the other hand, the Nwugarian technique; VOP, propunded by Nwuga is a home-grown spinal manipulation approach in Nigeria demonstrated the effectiveness of VOP on pain and disability in patients with mechanical lowback pain. VOP, in combination with lumbar stabilization exercises has also been noted to be more effective compared with VOP in isolation in the management chronic low back pain . Similarly, Egwu et al., concluded that VOP has significant effects on pain intensity and Lumbo-sacral mobility, and opined that VOP should be preferred as spinal mobilization therapy outcome measures in youths and elderly individuals with LBP. The effectiveness of VOP is hinged on few available studies. VOP requires pressure on the vertebral spinous process with oscillation by the therapist. The therapeutic mechanism of spinal manipulation have emphasized the importance of directing forces to specific spinal joints for the purpose of correcting a biomechanical dysfunction or misalignment . Studies have also shown and validated spinal manipulation to affect both sensory and motor nerve activity as well as electromyographic measured muscle activity . Outcome measures reflect the impact of the health care service or intervention on the health status of patients. To achieve comprehensive multidimensional evaluation of outcome in LBP ,one of the core outcome domains that must be considered is pain, the method of assessing has always been participants rating of improvement and satisfaction with treatment but not the effects of intervention at cellular level. Use of serum biomarkers has the potential to measure the effects of intervention at cellular level thereby helping to identify relevant treatment options and decrease the likelihood of failed interventions. However, effects of known treatment like VOP and SNAGS on the inflammatory status and bio cellular pain substance in patients with long term low-back pain has not been explored, ,hence this study This study is therefore aimed to investigate and compare the effect of VOP and SNAGS on pain-biomarkers, disability, flexibility and health-related quality of life in patients with mechanical LBP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Specific Low Back Pain
Keywords
Low back pain,, Vertical Oscillatory Pressure,, Sustained Natural Apophzeal Glide,, Pain-Biomakers, Health Related Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There were two groups; Vertical Oscillatory and Sustained Natural Apophyseal group. Participants were allocated to each group randomly. Each group received intervention accordingly
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verical Oscillatory Pressure (VOP)
Arm Type
Experimental
Arm Description
Vertical Oscillatory Pressure (VOP) will be administered with the patient lying prone on a couch. The researcher will place the thumb reinforced with the other thumb on the implicated lumbar vertebra, then apply pressure posterior anteriorly on the spinous process and oscillate for a maximum of 60 seconds. This will be done on each patient in this group twice a week for 6 weeks after an initial assessment both subjective and objective (Egwu et al, 2007).
Arm Title
Sustained Natural Apophyzeal Glides
Arm Type
Experimental
Arm Description
Participant in this group will undergo SNAG technique on lumbar vertebra with active spinal movement according to Mulligan, (2004). Participants will be in a sitting position on the edge of the couch while both feet will be on a footrest. A stabilization belt will be used around the patient's waist and the therapist's hips and the researcher standing behind the patient well supported with stabilization belt. The researcher places one thumb or hypothenar eminence (pisiform bone) reinforced by the other on the spinous process of the implicated lumbar vertebra and then apply pressure posterior-anteriorly on the spinous process, the pressure will be sustained and the patient concurrently performs active spinal movement. SNAGS will be applied with 3 repetitions on the first day and 10 repetitions from next visit. SNAG will be used twice a week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Vertical Oscillatory Pressure (VOP)
Other Intervention Name(s)
Sustained Natural Apophyseal Glides (SNAGs)
Intervention Description
The VOP involves a pressure from the posterior aspect of the body while patient lye prone. the pressure is exacted directly on the spine, The sustained Natural Apophyseal Glides involves pressure as well when the patient sits down on a chair. The movement is done from the posterior to the anterior as well
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Pain perception: Which is measured by Visual Analogue Scale . This is an instrument that measure the pain perception of the patients. The minimum is 0, which indicated no pain and the maximum is 10 which described excruciating pain
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Interleuking 6
Description
Concentration of pain factors in the blood. It is an chemical in the blood that determines how individuals perceive pain in the body. The minimum is 30 which indicate no pain and the maximum could be 250 which indicate extreme pain
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with non specific low back pain of at least 3 months duration age of 18-75 years No history of hospitalization in the last 12 months Exclusion Criteria: No history of trauma organic diseases No mental disorderliness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adesola O Ojoawo, PhD
Organizational Affiliation
Obafemi Awolowo University Ile ife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obafemi Awolowo University
City
Ile-Ife
State/Province
Osun
ZIP/Postal Code
220005
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data may not be shared with other researchers
Citations:
PubMed Identifier
26591674
Citation
Ojoawo AO, Olaogun MO, Odejide SA, Badru AA. Effect of vertical oscillatory pressure on disability of patients with chronic mechanical low back pain using Roland Morris Disability questionnaire. Tanzan J Health Res. 2013 Jan;15(1):58-63. doi: 10.4314/thrb.v15i1.9.
Results Reference
background
PubMed Identifier
30930571
Citation
Ogunlana MO, Odole AC, Adejumo A, Odunaiya N. Catastrophising, pain, and disability in patients with nonspecific low back pain. Hong Kong Physiother J. 2015 Dec;33(2):73-79. doi: 10.1016/j.hkpj.2015.03.001. Epub 2015 Apr 16.
Results Reference
background
PubMed Identifier
2198912
Citation
Roche RJ, Silamut K, Pukrittayakamee S, Looareesuwan S, Molunto P, Boonamrung S, White NJ. Quinine induces reversible high-tone hearing loss. Br J Clin Pharmacol. 1990 Jun;29(6):780-2. doi: 10.1111/j.1365-2125.1990.tb03704.x.
Results Reference
background

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Vertical Oscillatory Pressure and Sustained Natural Apophyseal Glides in ow Back Pain

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