NCT06757400

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 26, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

May 26, 2024

Last Update Submit

January 3, 2025

Conditions

Keywords

non-specific low back painmanual therapyhypoalgesiapressure pain threshold

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

EXPERIMENTAL

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: MobilizationOther: manipulation

Manipulation

ACTIVE COMPARATOR

27 patients with chronic low back pain will be assigned to receive one intervention with lumbar manipulation

Other: MobilizationOther: 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.

ManipulationMobilization

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.

ManipulationMobilization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 33197571BACKGROUND
  • 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.

    PMID: 15611489BACKGROUND
  • 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.

    PMID: 30867144BACKGROUND
  • 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.

    PMID: 32100027BACKGROUND
  • 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.

    PMID: 22296867BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations