Low Back PainNCT06712992
Electromyographic Response to TsDcs in CNSLBP
A study testing Trans-spinal Direct Current Stimulation and Conventional Exercises in people with Low Back Pain, run by German International University at 2 sites in Egypt.
Trial summary
The purpose of this randomized, double-blinded, sham-controlled study is to investigate the efficacy of trans-spinal direct current stimulation on pain level, quality of life, and electromyographic nociceptive flexion reflex in patients with non-specific chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Trans-spinal Direct Current Stimulation and Conventional Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 May 2024to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Individuals of both sexes.
- Age 18-60 years old.
- Chronic non-specific low back pain according to the most recent guidelines for the diagnosis and management of NSLPB come from the American College of Physicians and was published in 2017. According to these guidelines, the diagnosis of chronic NSLBP should be made based on the following criteria:
- Chronic low back pain, defined as pain lasting for more than 12 weeks.
- No specific identifiable cause of pain(e.g. infection, malignancy, fracture, inflammatory disorder).
- No radicular symptoms(e.g. pain radiating down the leg).
- No significant neurological deficits or findings on physical examination(e.g. loss of reflexes or muscle strength).
Who cannot join
- Previous fractures and/or surgery in the vertebral spine.
- Neuropathic pain extending along the lower limb due to nerve root compression.
- History of spine trauma or fracture.
- Implanted pacemakers.
- Pregnancy.
- Malignancy.
Show all 10Show fewer
- Systemic musculoskeletal diseases.
- Epilepsy.
- History of psychiatric disorders.
- Obesity
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Sixth of October, Giza Governorate, 12611
Outpatient clinical of faculty of physical therapy, Ahram Canadian University
Sixth of October, Giza Governorate, 12611
About this study
Official title: Effect of Trans-Spinal Direct Current Stimulation in the Management of Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
The purpose of this randomized, double-blinded, sham-controlled study is to investigate the efficacy of trans-spinal direct current stimulation on pain level, quality of life, and electromyographic nociceptive flexion reflex in patients with non-specific chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Trans-spinal Direct Current Stimulation, Conventional Exercises, SHAM Trans-spinal Direct current stimulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-spinal Direct Current StimulationDevice
Physiomed- IONOSON-Expert, Germany will be used to deliver SHAM direct current, The Physiomed- IONOSON-Expert, Germany is Two-channel electrotherapy including 21 currents, including direct current. The tsDCS electrodes will be rectangular pieces of saline-soaked synthetic sponge (7 × 8 cm, 56 cm2), to minimize chemical reactions at the electrode-skin interface. The anode will be placed over the spinous process of the eighth thoracic vertebra (T8) and the cathode will be placed on the second lumbar vertebra (L2) according to a modeling study which demonstrated that this configuration had a relevant impact on the distribution of the induced electric field (EF) in the lumbosacral spinal cord for the efficacy of tsDCS.
Conventional ExercisesOther
- Isometric exercises of spine
- Hollowing in abdominals.
- Isometric for back extensors.
- Bridging exercises.
- Graded active flexion exercises of spine
- Graded active extension exercises of spine
SHAM Trans-spinal Direct current stimulationDrug
For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions.
These parameters for sham stimulation were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade usually out in the first 30 s of TsDcs .
| Study group | Role | What they receive |
|---|---|---|
| Trans-spinal direct current stimulation group | Experimental | Patients in this group will receive Conventional Exercises in addition to tsDCS. We will apply a current density of 0.035 mA/cm2 and will deliver a total charge density of 42.8 mC/cm2, below the threshold values reported for tissue damage. For tsDcs, At the onset of tsDCS, the current will be increased for 30 s, and at the offset, it will be decreased for 30 s in a ramp-like manner. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions. Receives: Device: Trans-spinal Direct Current Stimulation; Other: Conventional Exercises |
| Sham Trans-spinal direct current stimulation group | Sham comparator | Patients in this group will receive Conventional Exercises in addition to SHAM tsDCS. For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions. Receives: Other: Conventional Exercises; Drug: SHAM Trans-spinal Direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in NPRS from baseline to four weeks
An 11-point Numerical Pain Rating Scale (NPRS; 0= no pain, 10= maximum pain) will be used to assess the patients' pre and post treatment levels of back pain. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Scores range from 0-10 points, with higher scores indicating greater pain intensity
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Changes in Nociceptive Flexion Reflex (NFR) Threshold and area from baseline to 4 weeks
The NFR threshold will be assessed as an objective measure of spinal nociceptive processing in adults with chronic non-specific low back pain (CNSLBP). The NFR threshold will be defined as the lowest stimulus intensity that elicits an NFR response.The NFR threshold and NFR area will be assessed before and after 4 weeks of trans-spinal direct current stimulation (tsDCS) plus exercise or sham stimulation plus exercise.
Measured: Baseline and 4 weeks
Changes in PROMIS Global Health - 10 Survey from baseline to 4 weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a comprehensive instrument designed to assess health-related quality of life across various domains. PROMIS GH-10, specifically, is tailored to measure global physical and mental health. It encompasses a range of items that evaluate general health perceptions, physical function, pain, fatigue, emotional distress, and social health. PROMIS GH-10 has been demonstrated to be reliable and valid for use in the general population and various specific conditions, such as low back pain.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start16 May 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Medhat Mahfouz Elgamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712992
- Sponsor's protocol ID
- P.T/REC/2024.10021
- Status last verified
- Mar 2025
- First submitted
- 26 Nov 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trans-Spinal Direct Current Stimulation in the Management of Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06712992
- Acronym / sponsor ID
- P.T/REC/2024.10021
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- German International UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 3 Dec 2024 (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.
The purpose of this randomized, double-blinded, sham-controlled study is to investigate the efficacy of trans-spinal direct current stimulation on pain level, quality of life, and electromyographic nociceptive flexion reflex in patients with non-specific chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-spinal direct current stimulation group | Experimental | Device: Trans-spinal Direct Current Stimulation, Other: Conventional ExercisesPatients in this group will receive Conventional Exercises in addition to tsDCS. We will apply a current density of 0.035 mA/cm2 and will deliver a total charge density of 42.8 mC/cm2, below the threshold values reported for tissue damage. For tsDcs, At the onset of tsDCS, the current will be increased for 30 s, and at the offset, it will be decreased for 30 s in a ramp-like manner. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions. |
| Sham Trans-spinal direct current stimulation group | Sham comparator | Other: Conventional Exercises, Drug: SHAM Trans-spinal Direct current stimulationPatients in this group will receive Conventional Exercises in addition to SHAM tsDCS. For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals of both sexes.
- Age 18-60 years old.
- Chronic non-specific low back pain according to the most recent guidelines for the diagnosis and management of NSLPB come from the American College of Physicians and was published in 2017. According to these guidelines, the diagnosis of chronic NSLBP should be made based on the following criteria:
- Chronic low back pain, defined as pain lasting for more than 12 weeks.
- No specific identifiable cause of pain(e.g. infection, malignancy, fracture, inflammatory disorder).
Key exclusion criteria (10 listed)
- Previous fractures and/or surgery in the vertebral spine.
- Neuropathic pain extending along the lower limb due to nerve root compression.
- History of spine trauma or fracture.
- Implanted pacemakers.
- Pregnancy.
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 |
|---|---|---|
| Trans-spinal Direct Current StimulationPhysiomed- IONOSON-Expert, Germany will be used to deliver SHAM direct current, The Physiomed- IONOSON-Expert, Germany is Two-channel electrotherapy including 21 currents, including direct current. The tsDCS electrodes will be rectangular pieces of saline-soaked synthetic sponge (7 × 8 cm, 56 cm2), to minimize chemical reactions at the electrode-skin interface. The anode will be placed over the spinous process of the eighth thoracic vertebra (T8) and the cathode will be placed on the second lumbar vertebra (L2) according to a modeling study which demonstrated that this configuration had a relevant impact on the distribution of the induced electric field (EF) in the lumbosacral spinal cord for the efficacy of tsDCS. | Device | Trans-spinal direct current stimulation group |
| Conventional Exercises1. Isometric exercises of spine * Hollowing in abdominals. * Isometric for back extensors. 2. Bridging exercises. 3. Graded active flexion exercises of spine 4. Graded active extension exercises of spine | Other | Sham Trans-spinal direct current stimulation group, Trans-spinal direct current stimulation group |
| SHAM Trans-spinal Direct current stimulationFor a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions. These parameters for sham stimulation were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade usually out in the first 30 s of TsDcs . | Drug | Sham Trans-spinal direct current stimulation group |
Primary outcome
Changes in NPRS from baseline to four weeks
Time frame: Baseline and 4 weeks
An 11-point Numerical Pain Rating Scale (NPRS; 0= no pain, 10= maximum pain) will be used to assess the patients' pre and post treatment levels of back pain. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Scores range from 0-10 points, with higher scores indicating greater pain intensity
2 secondary outcomes
Changes in Nociceptive Flexion Reflex (NFR) Threshold and area from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Changes in PROMIS Global Health - 10 Survey from baseline to 4 weeks
Time frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-spinal Direct Current Stimulation and Conventional Exercises in people with Low Back Pain, run by German International University at 2 sites 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in NPRS from baseline to four weeks (time frame: Baseline and 4 weeks). 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 12 Mar 2025.