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RecruitingNCT05972395Updated Aug 2, 2023

Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain

An observational study in Chronic Low-back Pain, sponsored by Ahram Canadian University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by Ahram Canadian University · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
75
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study aims to compare function of the body's endogenous pain modulation system between people with localized low back pain versus widespread body pain. Endogenous pain modulation refers to the body's natural ability to inhibit one pain stimulus by applying a second pain stimulus. This study will assess pain inhibition by measuring pressure pain thresholds at the low back before and during cold water hand immersion. The researchers hypothesize that those with widespread body pain will have worse functioning of pain inhibition compared to those with localized low back pain only. The results may provide insights into personalized chronic pain management approaches.

Read the detailed description

Chronic low back pain (CLBP) is highly prevalent worldwide. Impairments in conditioned pain modulation (CPM) have been documented in CLBP populations. CPM refers to endogenous pain inhibition, where one noxious stimulus inhibits pain from a second noxious stimulus. This relies on descending inhibitory pathways. However, it is unknown whether CPM alterations differ between individuals with localized versus widespread mechanical pain hypersensitivity. The aim of this cross-sectional quantitative sensory testing study is to compare CPM function between localized and widespread CLBP subgroups. A sample of 75 adults with CLBP of at least 3 months duration will be recruited from a chronic pain clinic. Based on pressure pain threshold mapping at the low back and distal sites, participants will be classified as having localized or widespread mechanical hyperalgesia.

02

Conditions studied

  • Chronic Low-back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 75 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Ahram Canadian University is the lead sponsor of 69 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with chronic nonspecific LBP stratified by localized vs widespread mechanical hyperalgesia

Inclusion criteria

  • Ages 18-60 years
  • Chronic LBP >3 months
  • Average LBP intensity ≥4/10

Exclusion criteria

Exclusion Criteria:

  • Known LBP pathologies
  • Previous lumbar surgery
  • Neuropathic LBP
  • Comorbid generalized pain conditions
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Localized CLBP

    Chronic low back pain \>3 months with localized pressure pain hyperalgesia

    Other: Localized vs Widespread Mechanical Pain Hypersensitivity

  • Widespread CLBP

    Chronic low back pain \>3 months with widespread pressure pain hyperalgesia

    Other: Localized vs Widespread Mechanical Pain Hypersensitivity

Interventions

  • OtherLocalized vs Widespread Mechanical Pain Hypersensitivity

    Based on pressure pain threshold mapping, participants will be classified as having either localized mechanical pain hyperalgesia (hyperalgesia limited to the lumbosacral region) or widespread mechanical pain hyperalgesia (hyperalgesia extending beyond the lumbosacral region).

06

What researchers measure

Primary outcomes

  1. Conditioned Pain Modulation

    Percent change in pressure pain threshold at the lumbar region during cold water hand immersion conditioning stimulus compared to baseline pressure pain threshold at the lumbar region without the conditioning stimulus.

    Time frame: Baseline

Secondary outcomes

  1. Pressure Pain Thresholds

    Pressure pain thresholds measured in kg/cm2 using a pressure algometer at the lumbar spine and distal sites including the upper trapezius and thumbnail.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
    Al Ḩayy Ath Thāmin, Giza 3221405, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05972395
Lead sponsor
Ahram Canadian University
Responsible party
Mohamed Magdy ElMeligie (Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University) — Principal investigator
First posted
Aug 2, 2023
Start date
Jul 28, 2023 (estimated)
Primary completion
Feb 25, 2024 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Aug 2, 2023

Study contacts

Mohamed M ElMeligie, Ph.d
Contact
mohamed.elmeligie@acu.edu.eg
+201064442032
Amal Fawzy, Ph.d
study chair · Faculty of Physical Therapy, Ahram Canadian University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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