Chronic Low-back PainNCT05972369
Sensory Nerve Function and Exercise Therapy Response in 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 observational study aims to compare measures of sensory nerve function between chronic low back pain patients matched for baseline pain and disability levels who are then classified as responders or non-responders after completing a 12-week tailored exercise program. 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?
- 12-Week Tailored Exercise Intervention
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 15 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 low back pain matched for baseline pain and disability levels.
Who may be able to join
- Adults ages 20-60 years
- Nonspecific chronic low back pain >3 months
- Baseline pain ≥6/10 and disability ≥40%
Who cannot join
- Radicular leg pain
- Prior lumbar surgery
- Serious spinal pathology
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: Comparing Sensory Nerve Conduction and Quantitative Sensory Testing Thresholds Between Matched Patients With Nonspecific Low Back Pain Categorized as Responders or Non-Responders to Exercise Therapy
This observational study aims to compare measures of sensory nerve function between chronic low back pain patients matched for baseline pain and disability levels who are then classified as responders or non-responders after completing a 12-week tailored exercise program. Measures collected include sural sensory nerve conduction, quantitative sensory testing for pressure and heat pain thresholds, and psychosocial questionnaires. It is hypothesized that baseline sensory nerve dysfunction may be associated with reduced response to exercise therapy in chronic low back pain.
Read the detailed description
While exercise is commonly prescribed for chronic nonspecific low back pain (NSLBP), patient responses are variable. Differences in baseline sensory nerve function could plausibly contribute to exercise therapy outcomes. This cross-sectional quantitative observational study will investigate if baseline sensory nerve conduction amplitudes and quantitative sensory testing (QST) pain thresholds differ between matched NSLBP patients later categorized as responders or non-responders to a 12-week standardized exercise regime. A sample of 50 NSLBP participants with matched baseline pain and disability will undergo a tailored 12-week exercise intervention and 6-month follow-up. Blinded assessors will perform post-intervention sensory nerve conduction and QST measures. It is hypothesized that exercise therapy responders will show greater improvements in sensory thresholds correlating with pain relief. Results aim to elucidate neural factors associated with long-term exercise therapy outcomes in chronic low back pain.
- Conditions
- Chronic Low-back Pain
- Being tested
- 12-Week Tailored Exercise Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-Week Tailored Exercise InterventionOther
12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise Responders | ≥30% improvement in pain with 12 weeks of prescribed exercise Receives: Other: 12-Week Tailored Exercise Intervention | |
| Exercise Non-responders | <30% improvement in pain with 12 weeks of prescribed exercise Receives: Other: 12-Week Tailored Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sural Sensory Nerve Conduction Amplitude
Baseline antidromic sural sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.
Measured: Baseline
Secondary outcomes (3)
Superficial Peroneal Sensory Nerve Conduction Amplitude
Baseline superficial peroneal sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.
Measured: Baseline
Pressure Pain Threshold
Pressure pain threshold (measured in kg/cm2) assessed using a pressure algometer at the lower back.
Measured: Baseline
Heat Pain Threshold
Heat pain threshold (measured in °C) assessed using a thermode applied to the calf.
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 start1 Aug 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion15 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
- 50 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 director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972369
- Sponsor's protocol ID
- 012/0701LBP02
- 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
- Comparing Sensory Nerve Conduction and Quantitative Sensory Testing Thresholds Between Matched Patients With Nonspecific Low Back Pain Categorized as Responders or Non-Responders to Exercise Therapy
- ClinicalTrials.gov ID
- NCT05972369
- Acronym / sponsor ID
- 012/0701LBP02
- Conditions
- Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 15 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 observational study aims to compare measures of sensory nerve function between chronic low back pain patients matched for baseline pain and disability levels who are then classified as responders or non-responders after completing a 12-week tailored exercise program. Measures collected include sural sensory nerve conduction, quantitative sensory testing for pressure and heat pain thresholds, and psychosocial questionnaires. It is hypothesized that baseline sensory nerve dysfunction may be associated with reduced response to exercise therapy in chronic low back pain.
Detailed description
While exercise is commonly prescribed for chronic nonspecific low back pain (NSLBP), patient responses are variable. Differences in baseline sensory nerve function could plausibly contribute to exercise therapy outcomes. This cross-sectional quantitative observational study will investigate if baseline sensory nerve conduction amplitudes and quantitative sensory testing (QST) pain thresholds differ between matched NSLBP patients later categorized as responders or non-responders to a 12-week standardized exercise regime. A sample of 50 NSLBP participants with matched baseline pain and disability will undergo a tailored 12-week exercise intervention and 6-month follow-up. Blinded assessors will perform post-intervention sensory nerve conduction and QST measures. It is hypothesized that exercise therapy responders will show greater improvements in sensory thresholds correlating with pain relief. Results aim to elucidate neural factors associated with long-term exercise therapy outcomes in chronic low back pain.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Responders | – | Other: 12-Week Tailored Exercise Intervention≥30% improvement in pain with 12 weeks of prescribed exercise |
| Exercise Non-responders | – | Other: 12-Week Tailored Exercise Intervention<30% improvement in pain with 12 weeks of prescribed exercise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with chronic nonspecific low back pain matched for baseline pain and disability levels.
Key inclusion criteria (3 listed)
- Adults ages 20-60 years
- Nonspecific chronic low back pain >3 months
- Baseline pain ≥6/10 and disability ≥40%
Key exclusion criteria (3 listed)
- Radicular leg pain
- Prior lumbar surgery
- Serious spinal pathology
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 |
|---|---|---|
| 12-Week Tailored Exercise Intervention12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise | Other | Exercise Non-responders, Exercise Responders |
Primary outcome
Sural Sensory Nerve Conduction Amplitude
Time frame: Baseline
Baseline antidromic sural sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.
3 secondary outcomes
Superficial Peroneal Sensory Nerve Conduction Amplitude
Time frame: Baseline
Pressure Pain Threshold
Time frame: Baseline
Heat Pain Threshold
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 director
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 3 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?
Sural Sensory Nerve Conduction Amplitude (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.