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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06757400
Enrollment
27
Registered
2025-01-03
Start date
2023-11-04
Completion date
2024-04-23
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Lumbago

Keywords

non-specific low back pain, manual therapy, hypoalgesia, pressure pain threshold

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%).

Interventions

OTHERMobilization

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 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.

Sponsors

University of West Attica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1. Pressure pain thresholdBaseline and 15 minutesChanges 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

MeasureTime frameDescription
Range Of Motion (ROM)Baseline and 15 minutesROM 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 IntensityBaseline and 15 minutesParticipants 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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026