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Clinical Trials/NCT06078033
NCT06078033
Completed
Not Applicable

Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients: A Randomized Controlled Trial

Eleuterio Atanasio Sánchez Romero1 site in 1 country58 target enrollmentDecember 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low-back Pain
Sponsor
Eleuterio Atanasio Sánchez Romero
Enrollment
58
Locations
1
Primary Endpoint
Conditioned pain modulation
Status
Completed
Last Updated
last year

Overview

Brief Summary

Patients with chronic low back pain may have altered endogenous mechanisms, which can be evaluated with conditioned modulation paradigms. Mobilization with movement has demonstrated improvements in endogenous analgesic mechanisms in conditions such as knee osteoarthritis or lateral epicondylalgia. However, its effects have not yet been studied in patients with chronic low back pain. The objective of this randomized clinical trial is to evaluate the efficacy of mobilization with movement compared to placebo on endogenous mechanisms in patients with chronic low back pain.

Detailed Description

Low back pain is the leading cause of disability worldwide, and chronic low back pain (CLBP) has a prevalence of 2-25%, 80% of which are classified as non-specific low back pain because the causal factors have not yet been determined. Although different mechanisms can be attributed to the chronification of pain, a frequent denominator is the amplification of nociceptive transmission or decreased inhibition of nociceptive stimuli in the peripheral and/or central nervous system. To assess inhibitory pathways, conditioned pain modulation (CPM) paradigms are commonly used in humans. They are based on the idea that a noxious stimulus applied to one part of the body can inhibit pain elsewhere by activating the descending inhibitory system. When CPM is evaluated in patients with chronic low back pain, contradictory results are found, with studies reporting an alteration of pain modulation mechanisms and others not. Different studies found that manual therapy can improve CPM compared to sham in patients with chronic musculoskeletal pain, such as lateral epicondylalgia or knee osteoarthritis. However, its effects in patients with chronic low back pain have not yet been studied. Therefore, the aim of this study was to investigate the effect of mobilization with motion on CPM in patients with chronic musculoskeletal pain.

Registry
clinicaltrials.gov
Start Date
December 2, 2023
End Date
May 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eleuterio Atanasio Sánchez Romero
Responsible Party
Sponsor Investigator
Principal Investigator

Eleuterio Atanasio Sánchez Romero

PhD, Clinical Professor

Universidad Europea de Madrid

Eligibility Criteria

Inclusion Criteria

  • Adults with chronic low back pain (\>3 months of pain duration)
  • 2 or more on a scale of 0 to 10.

Exclusion Criteria

  • Radiculopathy
  • Neurological signs, symptoms, or deficit
  • Rheumatic or autoimmune disease
  • Cutaneous disease
  • History of fracture or spinal surgery
  • Pregnancy
  • Neuropathic pain
  • Active cancer
  • Spondylolysis/Spondylolisthesis
  • Mild/Severe cognitive impairment which interferes with outcomes measurement

Outcomes

Primary Outcomes

Conditioned pain modulation

Time Frame: 30 minutes

Conditioned pain modulation of low back, measured on interspace between L5 and S1. Pressure pain threshold (PPT) was used as test stimulus while ischemic pain (using cuff) was used as conditioning stimulus. CPM effect were calculated as the differences between the PPT values with and without the conditioning stimulus.

Secondary Outcomes

  • Body Chart(Baseline)
  • Anxiety(Baseline)
  • Depression(Baseline)
  • Pressure pain threshold(30 minutes)
  • Kinesiophobia(Baseline)
  • Disability(Baseline)
  • Quality of life (QoL)(Baseline)

Study Sites (1)

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