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Completed

NCT Number: NCT05484791

The Effect of a Lumbar Rotational Spinal Mobilization Technique With Lumbar Disc Herniation

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

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muş Alparslan University

Muş, Turkey (Türkiye)

About this study

In our study, it was aimed to investigate the acute effect of Lumbar Rotational Spinal Mobilization Technique on radiological findings, pain, disability and range of motion in 26 patients diagnosed with lumbar disc herniation(LDH) by magnetic resonance imaging(MRI) and physical examination. Disc height, herniation distance and facet joint distance of the patients were measured with MRI. Pain was assessed with the Visual Analogue Scale. Disability was measured with the Oswestry Low Back Pain Disability Questionnaire and Lumbar range of motion(ROM) was measured with a goniometer and tape measure. Rotational Spinal Mobilization Technique was applied to the patients in 2 sessions with a one-week interval, slowly and with 30 repetitions in both directions. All assessments were repeated within 1 week after treatment. It was observed whether there was an improvement in terms of radiological, pain, disability and ROM in the patients. 2 months after the 2nd evaluation, other parameters except the radiological evaluation were reapplied and it was tried to determine whether the effect persisted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

The Lumbar Rotational Spinal Mobilization Technique

Other

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

Primary outcomes

  1. Assessing disc height change

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

    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

  2. Assessing disc herniation thickness change

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

    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

  3. Assessing facet joint distance change

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

    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

Secondary outcomes

  1. Functional capacity change assessment

    Time frame: 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.

    The Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) was used to assess disability levels and quality of life linked to low back pain of patients. The OLBPDQ was developed to assess disability linked to pain for people with acute, subacute or chronic low back pain. The OLBPDQ contains 1 item related to pain and 9 items related to daily life activities (personal care, lifting, walking, sitting, standing, sleep, sexual life, social life and travel). Each item is rated on a 6-point scale ranked from the best scenario to the worst scenario. Points for each item increase by 1 for each response choice from 0 (first response choice) to 5 (final response choice). Missing values are skipped. Total points are calculated as a percentage value

  2. Pain change assessment

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

    The pain levels felt by patients in their low back and surrounding regions was assessed with the visual analog scale (VAS). On this assessment, the patient expresses the pain levels felt by marking their position on a 10 cm scale numbered from 0 to 10 where 0 indicates no pain and 10 indicates unbearable pain. Cases are requested to express their pain by marking the appropriate number for their pain level on the scale and the value is recorded in cm.

Other outcomes

  1. Evaluation of joint range of motion change

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

    All patients participating in the study had lumbar flexion, lumbar extension, lumbar lateral flexion and lumbar rotations measured. Lumber flexion and lumbar lateral flexion were obtained by measuring the distance between the ground and middle finger tip with a tape measure. Lumber extension and lumbar rotations were measured with a goniometer

Sponsors and collaborators

Lead sponsor

Muş Alparslan University

Other

Registry information

Official study title

Acute Effect Of The Lumbar Rotational Spinal Mobilization Technique On Pain, Disability And Radiological Findings Of Patients With Lumbar Disc Herniation

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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