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

Not Applicable

Completed

• Conditions: Low Back Pain; Lumbago

• Registration Number: NCT06757400
• Lead Sponsor: University of West Attica

Brief Summary

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.

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 Timeline

• Study Start: 2023-11-04
• Primary Completion: 2024-02-28
• Study Completion: 2024-04-23
• Study First Submitted: 2024-05-26
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-26
• Study First Posted: 2025-01-03
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
1. Pressure pain threshold	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 Outcome Measures

Name	Time	Method
Range Of Motion (ROM)	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
Pain Intensity	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

Trial Locations

Locations (1)

Thomas Sampsonis; 🇬🇷 Peristéri, Αττικης, Greece