NCT05484791

Brief Summary

The aim of this study was to research the effect of the Lumbar Spinal Rotational Mobilization technique on radiological findings, pain, disability and joint range of motion (ROM) in patients with lumbar disc herniation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

December 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 19, 2022

Last Update Submit

July 30, 2022

Conditions

Keywords

Lumbar disc herniationManual therapyLumbar Spinal Rotational Mobilization

Outcome Measures

Primary Outcomes (3)

  • Assessing disc height change

    Images for radiological assessment of patients were obtained with a 1.5 Tesla GE brand Magnetic Resonance (MR) device. Sagittal T2A and axial T2A sequences were used. If the same person had herniation at different levels, the level with highest degree of herniation was included in the assessment. All MR images were obtained during the day between 16:00 and 18:00 hours

    Disc height, was measured twice by a radiology expert 1 week before and 1 week after treatment

  • Assessing disc herniation thickness change

    Images for radiological assessment of patients were obtained with a 1.5 Tesla GE brand Magnetic Resonance (MR) device. Sagittal T2A and axial T2A sequences were used. If the same person had herniation at different levels, the level with highest degree of herniation was included in the assessment. All MR images were obtained during the day between 16:00 and 18:00 hours

    Disc herniation thickness was measured twice by a radiology expert 1 week before and 1 week after treatment

  • Assessing facet joint distance change

    Images for radiological assessment of patients were obtained with a 1.5 Tesla GE brand Magnetic Resonance (MR) device. Sagittal T2A and axial T2A sequences were used. If the same person had herniation at different levels, the level with highest degree of herniation was included in the assessment. All MR images were obtained during the day between 16:00 and 18:00 hours

    Facet joint distance was measured twice by a radiology expert 1 week before and 1 week after treatment

Secondary Outcomes (2)

  • Functional capacity change assessment

    The functional capacity of patients participating in the study was assessed 1 week before, 1 week and 2 months after treatment using the Oswestry Low Back Pain Disability Questionnaire.

  • Pain change assessment

    Pain assessment was recorded 1 week before, 1 week and 2 months after treatment

Other Outcomes (1)

  • Evaluation of joint range of motion change

    Joint range of motion was assessed and recorded 1 week before, 1 week and 2 months after treatment

Study Arms (1)

The Lumbar Rotational Spinal Mobilization Technique

EXPERIMENTAL

Patients included in the study underwent the lumbar rotational spinal mobilization technique during two sessions per week

Other: The Lumbar Rotational Spinal Mobilization Technique

Interventions

Patients included in the study underwent the lumbar rotational spinal mobilization(LRSM) technique during two sessions per week. The LRSM technique is applied while patients are lying on their side. The uppermost hip and knee are placed in 90 degree flexion, this is to assist rotational stress, and the lower leg is placed in extension. The lower shoulder is strongly pulled; thus, the upper shoulder is positioned toward the posterior and the pelvis moves anteriorly. The clinician stands in front of the patient. They stabilize the upper shoulder with one hand, and place the palm of the other hand behind the hard part of the ilium wing, with forearm horizontal and fingers turned toward the clinician. A rotational force is applied with pressure in the horizontal direction by pulling the hand on the ilium toward the clinician. In this position, 30 slow repeated movements are performed. The same practice is performed on both sides

The Lumbar Rotational Spinal Mobilization Technique

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being diagnosed with LDH by MRI and physical examination
  • Having pain due to LDH
  • Be between the ages of 18 and 65

You may not qualify if:

  • History Of Spinal Surgery
  • History Of Autoimmune Disease (Ankylosing Spondylitis, Rheumatoid Arthritis Or Other Disease)
  • Spondylolysis Or Spondylolisthesis
  • Spinal Fracture
  • Cardiac Pathology
  • Stroke History
  • Cauda Equina Syndrome,
  • Continuous Painkiller Drug Use
  • Spinal inflammation
  • Spinal Tumor
  • Corticosteroid Drug Use İn The Last Month
  • Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muş Alparslan University

Muş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • İsmail Taşkent

    Muş State Hospital

    STUDY CHAIR
  • Mahmut Çakıllı

    Muş State Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The research was designed as a semi-experimental study with pre-test (before implementation), post-test (after implementation) and 2-month follow-up assessments
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2022

First Posted

August 2, 2022

Study Start

December 1, 2019

Primary Completion

April 1, 2020

Study Completion

August 1, 2020

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations