Chronic Low-back PainNCT05972395
Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Localized vs Widespread Mechanical Pain Hypersensitivity
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with chronic nonspecific LBP stratified by localized vs widespread mechanical hyperalgesia
Who may be able to join
- Ages 18-60 years
- Chronic LBP >3 months
- Average LBP intensity ≥4/10
Who cannot join
- Known LBP pathologies
- Previous lumbar surgery
- Neuropathic LBP
- Comorbid generalized pain conditions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Determining if Conditioned Pain Modulation Differs Between Individuals With Localized Versus Widespread Mechanical Pain Hypersensitivity in Chronic Low Back Pain
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Localized vs Widespread Mechanical Pain Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Localized vs Widespread Mechanical Pain HypersensitivityOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Localized CLBP | Chronic low back pain >3 months with localized pressure pain hyperalgesia Receives: Other: Localized vs Widespread Mechanical Pain Hypersensitivity | |
| Widespread CLBP | Chronic low back pain >3 months with widespread pressure pain hyperalgesia Receives: Other: Localized vs Widespread Mechanical Pain Hypersensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start28 Jul 2023 (estimated)
- Primary completion25 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972395
- Sponsor's protocol ID
- LBP01
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining if Conditioned Pain Modulation Differs Between Individuals With Localized Versus Widespread Mechanical Pain Hypersensitivity in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05972395
- Acronym / sponsor ID
- LBP01
- Conditions
- Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Localized CLBP | – | Other: Localized vs Widespread Mechanical Pain HypersensitivityChronic low back pain >3 months with localized pressure pain hyperalgesia |
| Widespread CLBP | – | Other: Localized vs Widespread Mechanical Pain HypersensitivityChronic low back pain >3 months with widespread pressure pain hyperalgesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with chronic nonspecific LBP stratified by localized vs widespread mechanical hyperalgesia
Key inclusion criteria (3 listed)
- Ages 18-60 years
- Chronic LBP >3 months
- Average LBP intensity ≥4/10
Key exclusion criteria (4 listed)
- Known LBP pathologies
- Previous lumbar surgery
- Neuropathic LBP
- Comorbid generalized pain conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Localized vs Widespread Mechanical Pain HypersensitivityBased 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). | Other | Localized CLBP, Widespread CLBP |
Primary outcome
Conditioned Pain Modulation
Time frame: 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.
1 secondary outcome
Pressure Pain Thresholds
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned Pain Modulation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.