Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain

Sponsor
Ahram Canadian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05972395
Collaborator
(none)
75
1
7.1
10.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Localized vs Widespread Mechanical Pain Hypersensitivity

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Determining if Conditioned Pain Modulation Differs Between Individuals With Localized Versus Widespread Mechanical Pain Hypersensitivity in Chronic Low Back Pain
Anticipated Study Start Date :
Jul 28, 2023
Anticipated Primary Completion Date :
Feb 25, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Localized CLBP

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

Other: Localized 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).

Widespread CLBP

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

Other: Localized 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).

Outcome Measures

Primary Outcome Measures

  1. Conditioned Pain Modulation [Baseline]

    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.

Secondary Outcome Measures

  1. Pressure Pain Thresholds [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Ages 18-60 years

  • Chronic LBP >3 months

  • Average LBP intensity ≥4/10

Exclusion Criteria:
  • Known LBP pathologies

  • Previous lumbar surgery

  • Neuropathic LBP

  • Comorbid generalized pain conditions

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Egypt 3221405

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

  • Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT05972395
Other Study ID Numbers:
  • LBP01
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2023