Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients with NSLBP
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Nov 2023
Shorter than P25 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2024
CompletedFirst Submitted
Initial submission to the registry
May 26, 2024
CompletedFirst Posted
Study publicly available on registry
January 3, 2025
CompletedJanuary 6, 2025
December 1, 2024
4 months
May 26, 2024
January 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Pressure pain threshold
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 Outcomes (2)
Range Of Motion (ROM)
Baseline and 15 minutes
Pain Intensity
Baseline and 15 minutes
Study Arms (2)
Mobilization
EXPERIMENTAL27 patients with chronic low back pain will be assigned to receive one intervention with grade IV posteroanterior (PA) mobilization in the Lumbar spine
Manipulation
ACTIVE COMPARATOR27 patients with chronic low back pain will be assigned to receive one intervention with lumbar manipulation
Interventions
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.
Eligibility Criteria
You may qualify if:
- to 60 years old
- diagniosed with non specific low back pain
- symptoms lasting for more than 12 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Sampsonis
Peristeri, Αττικης, 12135, Greece
Related Publications (5)
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.
PMID: 33197571BACKGROUNDChilds 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.
PMID: 15611489BACKGROUNDRubinstein 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.
PMID: 30867144BACKGROUNDArribas-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.
PMID: 32100027BACKGROUNDCoronado 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.
PMID: 22296867BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Physiotherapy Dept, University of West Attica
Study Record Dates
First Submitted
May 26, 2024
First Posted
January 3, 2025
Study Start
November 4, 2023
Primary Completion
February 28, 2024
Study Completion
April 23, 2024
Last Updated
January 6, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share