Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain

NCT ID: NCT05972395

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-28

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low-back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Localized CLBP

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

Localized vs Widespread Mechanical Pain Hypersensitivity

Intervention Type OTHER

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

Localized vs Widespread Mechanical Pain Hypersensitivity

Intervention Type OTHER

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed M ElMeligie, Ph.d

Role: CONTACT

+201064442032

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed M ElMeligie, Ph.d

Role: primary

01064442032

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LBP01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Modulation of Painful Perception
NCT02528578 COMPLETED NA
Comparison of Two Different Fascial Treatments
NCT06715969 ENROLLING_BY_INVITATION NA
Prevalence Of Disability And Fear Avoidance Beliefs
NCT07286630 ENROLLING_BY_INVITATION