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NCT Number: NCT06757400

Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients With NSLBP

Manual therapy, including mobilizations and manipulations, appears to be as effective as other types of therapy for chronic low back pain.

The aim of this cross-sectional study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain.

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Key information

Conditions

Low Back Pain Back Pain Lumbago Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Sampsonis

Peristeri, Αττικης, 12135, Greece

About this study

Background: Manual therapy, including mobilizations and manipulations, appears to be equally effective as other types of therapy for chronic low back pain. According to the Orthopaedic Section of the American Physical Therapy Association (APTA), there is evidence indicating that these techniques can reduce pain, improve spinal and hip mobility, and decrease disability in patients with low back pain. The aim of this study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain.

Methods: The present study will be a cross-sectional study in which participants will be men and women aged 18 to 60 years. The sample size was estimated by effect size, with a minimum of 27 participants required to provide statistically or clinically significant results. Each subject will receive two interventions-mobilization or manipulation-on two different days, in a random order. The primary outcomes will be pain perception, including subjective pain intensity and pressure pain threshold. Secondary outcomes will include the range of motion (ROM) of lumbar spine flexion, extension, and lateral flexion. Data will be collected before and after each intervention. Assessors will use a digital algometer, an electronic inclinometer, and a numerical rating scale (NRS). ANOVA and t-test calculations will be performed on data processed by SPSS Version 25 to analyze results for all outcomes. The level of significance will be set at 5% (p = 0.05) with a confidence interval of 95% (CI = 95%).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 to 60 years old
  • diagniosed with non specific low back pain
  • symptoms lasting for more than 12 weeks

Exclusion criteria

  • spinal fractures,
  • neurological impairment due to herniated spinal disc,
  • spondylolisthesis,
  • joint degenerative diseases,
  • osteoporosis,
  • spinal infections,
  • cauda equina syndrome,
  • spinal tumors or bone marrow malignancies,
  • spinal surgeries
  • history of cancer,
  • use of steroids

Treatment and study plan

Mobilization

Other

Mobilization will be conducted on an examination table with the subject in prone position. Therapist will place his hypothenar to the most hypomobile lumbar spine segment after assessment.It will be a posteroanterior (PA) direction tecnique, Maitland's GRADE 4, 3 sets of 60 seconds duration for each set.

manipulation

Other

Manipulation will be conducted on an examination table with the subject in right lateral decubitus. It will be a rotary manipulation to the most hypomobile lumbar spine segment after assessment.

Primary outcomes

  1. 1. Pressure pain threshold

    Time frame: Baseline and 15 minutes

    Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using at the L5 spinous process, upper trapezius muscle the tibialis anterior muscle. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group.

Secondary outcomes

  1. Range Of Motion (ROM)

    Time frame: Baseline and 15 minutes

    ROM will be measured in sagittal (flexion and extension) and frontal planes (right and left lateral bending) using an electronic goniometer. The participants will perform each movement three times were performed and the average will be recorded for the analysis

  2. Pain Intensity

    Time frame: Baseline and 15 minutes

    Participants will complete a self- reported numerical pain rating scale (NRS) from 0-10, with "0" indicated no pain and "10" the maximum possible pain, covering pain intensity over the past week

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study title

Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients With Non-specific Chronic Low Back Pain: a Cross-over Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2025
Registry last updated
Jan 6, 2025

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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