NCT04475770

Brief Summary

Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime. Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Low back pain has been shown to alter the structure of deep and superficial muscles such as multifidus and erector spinae. However, it has not been fully explained how changes in muscle fiber structure affect the biomechanical properties and functions of the muscle. There are various manual therapy techniques in the treatment of low back pain. Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment. Ultrasound shear wave elastography (SWE) provides an advantage since it can quantitatively assess tissue elasticity of in vivo skeletal muscles through non-invasive high-frequency ultrasound waves. The aim of this study was to investigate the acute effect of Mulligan SNAGs on the stiffness of muscle tissue by using Ultrasound shear wave elastography which is an objective assessment technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable low-back-pain

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

First Submitted

Initial submission to the registry

July 14, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

July 14, 2020

Last Update Submit

September 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • muscle stiffness

    The muscle stiffness of lumbar back muscles will be assessed using the B-mode of the ultrasound Shear Wave Elastography (SWE) imaging device. Longitudinal ultrasound Shear Wave Elastography images of the multifidus and erector spinal muscles will be taken bilaterally with a linear array probe in the prone position.

    4 weeks

Secondary Outcomes (7)

  • The sit and reach test

    4 weeks

  • Visual Analogue Scale

    4 weeks

  • The Functional Reach Test

    4 weeks

  • The Flamingo Balance Test

    4 weeks

  • Lateral bridge test

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Real SNAGs

EXPERIMENTAL

Real SNAGs group consists of 16 participants, where the Mulligan concept lumbal SNAGs is applied and evaluations are made before and after.

Other: Real Sustained Natural Apophyseal Glides (SNAGS)

Sham SNAGs

SHAM COMPARATOR

The Sham SNAGs group consists of 16 participants who performed the same positioning as the Real SNAGs group and evaluated twice with a similar interval without any intervention to the spine.

Other: Sham Sustained Natural Apophyseal Glides (SNAGS)

Interventions

Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.

Real SNAGs

The participants in the Sham SNAGs group will be positioned same as the SNAG group. Mulligan belt will be used, which included the patient's waist and physiotherapist's hip. The physiotherapist will place the hypothenar region of his hand on the spinous processes of the symptomatic lumbar spine levels and waited a few seconds without no glide will be performed. Sham SNAGs practice consisted of 3 sets of 6 repetitions and a 60-second rest period was given between the sets.

Sham SNAGs

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients who diagnosed with non-specific low back pain
  • between the ages of 18-24
  • patients who able to perform at least 40° of trunk flexion

You may not qualify if:

  • patients who obese, pregnant, had specific low back pain
  • indication for surgery in the past 1 year
  • the trauma of lumbar region, and systemic inflammatory disease affecting this area
  • exercise and conventional physiotherapy in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Eyalet/Yerleşke, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

July 15, 2020

Primary Completion

September 15, 2020

Study Completion

November 1, 2020

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations