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Non Specific Low Back PainVOP&SNAGNCT05612308

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

A study testing Vertical Oscillatory Pressure (VOP) in people with Non Specific Low Back Pain, run by Obafemi Awolowo University at 1 site in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) . Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Specific Low Back Pain
What is being tested?
Vertical Oscillatory Pressure (VOP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteNigeria
Study dates
24 Sep 2021to 10 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • No history of trauma
  • organic diseases
  • No mental disorderliness

Trial locations and contacts

1 site in 1 country.

Nigeria1 site
  • Obafemi Awolowo University

    Ile-Ife, Osun State, 220005

Other trials in Nigeria

About this study

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

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.

Read the 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.

Being tested
Vertical Oscillatory Pressure (VOP)
Keywords
Low back pain,, Vertical Oscillatory Pressure,, Sustained Natural Apophzeal Glide,, Pain-Biomakers, Health Related Quality of Life
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vertical Oscillatory Pressure (VOP)Other

    Also called Sustained Natural Apophyseal Glides (SNAGs)

    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

Study groups in NCT05612308
Study groupRoleWhat they receive
Verical Oscillatory Pressure (VOP)ExperimentalVertical 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).
Receives: Other: Vertical Oscillatory Pressure (VOP)
Sustained Natural Apophyzeal GlidesExperimentalParticipant 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.
Receives: Other: Vertical Oscillatory Pressure (VOP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 weeks

Secondary outcomes (1)
  1. 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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2022
  2. Study start24 Sep 2021
  3. Primary completion18 Jul 2022
  4. Study completion10 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05612308
Sponsor's protocol ID
Ojo/2022/02
Acronym
VOP&SNAG
Status last verified
Nov 2022
First submitted
31 Oct 2022
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data may not be shared with other researchers

Publications

  • 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.

    PubMed 26591674
  • 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.

    PubMed 30930571
  • 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.

    PubMed 2198912

Questions about this trial

What is this clinical trial studying?

A study testing Vertical Oscillatory Pressure (VOP) in people with Non Specific Low Back Pain, run by Obafemi Awolowo University at 1 site in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05612308, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

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