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

January 3, 2025 updated by: Stefanos Karanasios, University of West Attica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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%).

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Αττικης
      • Peristéri, Αττικης, Greece, 12135
        • Thomas Sampsonis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobilization
27 patients with chronic low back pain will be assigned to receive one intervention with grade IV posteroanterior (PA) mobilization in the Lumbar spine
Other: Mobilization
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.
Other: manipulation
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.
Active Comparator: Manipulation
27 patients with chronic low back pain will be assigned to receive one intervention with lumbar manipulation
Other: Mobilization
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.
Other: manipulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 15 minutes
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
Baseline and 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of West Attica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

April 23, 2024

Study Registration Dates

First Submitted

May 26, 2024

First Submitted That Met QC Criteria

December 26, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65273- 07/07/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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