Clinical trial NCT06757400: Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients with NSLBP
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lumbago
Keywords: non-specific low back pain
manual therapy
hypoalgesia
pressure pain threshold
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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%).

Eligibility criteria: 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

Primary outcomes:
measure: 1. Pressure pain threshold
timeFrame: Baseline and 15 minutes
Secondary outcomes:
measure: Range Of Motion (ROM)
timeFrame: Baseline and 15 minutes
measure: Pain Intensity
timeFrame: Baseline and 15 minutes
Other outcomes:
Locations:
city: Peristéri
country: Greece
facility: Thomas Sampsonis
state: Αττικης
Study officials:
References:
citation: Dal Farra F, Risio RG, Vismara L, Bergna A. Effectiveness of osteopathic interventions in chronic non-specific low back pain: A systematic review and meta-analysis. Complement Ther Med. 2021 Jan;56:102616. doi: 10.1016/j.ctim.2020.102616. Epub 2020 Nov 13.
citation: Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, Delitto A. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004 Dec 21;141(12):920-8. doi: 10.7326/0003-4819-141-12-200412210-00008.
citation: Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.
citation: Arribas-Romano A, Fernandez-Carnero J, Molina-Rueda F, Angulo-Diaz-Parreno S, Navarro-Santana MJ. Efficacy of Physical Therapy on Nociceptive Pain Processing Alterations in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2502-2517. doi: 10.1093/pm/pnz366.
citation: Coronado RA, Gay CW, Bialosky JE, Carnaby GD, Bishop MD, George SZ. Changes in pain sensitivity following spinal manipulation: a systematic review and meta-analysis. J Electromyogr Kinesiol. 2012 Oct;22(5):752-67. doi: 10.1016/j.jelekin.2011.12.013. Epub 2012 Jan 30.