NCT05612308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

October 31, 2022

Last Update Submit

November 4, 2022

Conditions

Keywords

Low back pain,Vertical Oscillatory Pressure,Sustained Natural Apophzeal Glide,Pain-BiomakersHealth Related Quality of Life

Outcome Measures

Primary Outcomes (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

    6 weeks

Secondary Outcomes (1)

  • Interleuking 6

    6 weeks

Study Arms (2)

Verical Oscillatory Pressure (VOP)

EXPERIMENTAL

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).

Other: Vertical Oscillatory Pressure (VOP)

Sustained Natural Apophyzeal Glides

EXPERIMENTAL

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.

Other: Vertical Oscillatory Pressure (VOP)

Interventions

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

Also known as: Sustained Natural Apophyseal Glides (SNAGs)
Sustained Natural Apophyzeal GlidesVerical Oscillatory Pressure (VOP)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obafemi Awolowo University

Ile-Ife, Osun State, 220005, Nigeria

Location

Related Publications (3)

  • 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.

    PMID: 26591674BACKGROUND
  • 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.

    PMID: 30930571BACKGROUND
  • 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.

    PMID: 2198912BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adesola O Ojoawo, PhD

    Obafemi Awolowo University Ile ife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There were two groups; Vertical Oscillatory and Sustained Natural Apophyseal group. Participants were allocated to each group randomly. Each group received intervention accordingly
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 10, 2022

Study Start

September 24, 2021

Primary Completion

July 18, 2022

Study Completion

September 10, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

The data may not be shared with other researchers

Locations