Low Back Pain (LBP)TENS in LBPNCT07535047
Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
A study testing TENS, TENS educational explanation video and Exercise in people with Low Back Pain (LBP) and Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The primary goal of this clinical trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT), considering recruitment, compliance with study protocols, and adverse events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain (LBP), Low Back Pain
- What is being tested?
- TENS, TENS educational explanation video and Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2026to 1 Sep 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute low back pain without radicular pain to lower limbs
- minimal pain level of 4 on the 0-10 VAS
- 18-65 years of age
- TENS naïve or have not used TENS in the past 5 years.
Who cannot join
- Radicular pain to lower limbs
- Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease
- Nerve root disorders confirmed by neurological tests
- Neurological diseases
- Severe cardiorespiratory disease
- Pregnancy
Show all 11Show fewer
- Skin infection or lesions or change in sensation at the TENS application site
- Cancer
- Cardiac pacemaker
- Allergy to electrodes
- use of opioids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Giza, Giza Governorate, 2356
Ahmed El Melhat, PhD, 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
Official title: Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation in Acute Low Back Pain
The primary goal of this clinical trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT), considering recruitment, compliance with study protocols, and adverse events. The secondary goal is to evaluate the effectiveness of a video-based educational explanation of transcutaneous electrical nerve stimulation (TENS) in eliciting placebo-induced hypoalgesia and improving clinical outcomes in patients with acute low back pain.
The main question it aims to answer is: Does the addition of a video-based educational explanation of TENS to standard physical therapy rehabilitation, consisting of TENS and exercises, increase the pressure pain threshold, reduce pain intensity, and improve functional mobility, patient satisfaction, and quality of life in patients with acute low back pain?
Participants will be divided into two groups for comparison: the control group will receive standard physical therapy rehabilitation consisting of TENS and exercises, while the experimental group will receive the same program in addition to the video-based educational explanation of TENS.
Read the detailed description
Pain modulation through expectation is a well-established phenomenon. Anticipating relief from a treatment can enhance the effects of both pharmacological and non-pharmacological analgesic interventions. The expectation of pain relief can reduce the perceived intensity of stimuli and is associated with changes in brain regions involved in pain processing, including the thalamus, prefrontal cortex, and somatosensory cortices. Previous research suggests that expectation can have a moderate to large effect on experimental and acute procedural pain.
Based on this, the investigators hypothesize that adding a video-based educational explanation of TENS to a standard physical therapy rehabilitation program will enhance patient expectations regarding the intervention. This may elicit placebo-induced hypoalgesia and improve clinical outcomes in patients with acute low back pain.
- Conditions
- Low Back Pain (LBP), Low Back Pain
- Being tested
- TENS, TENS educational explanation video, Exercise
- Keywords
- TENS, Transcutaneous Electrical Nerve Stimulation, Placebo, Hypolagesia
- 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.
TENSDevice
Also called Transcutaneous Electrical Nerve Stimulation
12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period .
TENS educational explanation videoBehavioural
The video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory
ExerciseOther
Participants will be provided with a home program consisting of exercises targeting trunk core activation, spinal mobility, and functional movement, as approved by the American Physical Therapy Association (APTA).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TENS + Educational Video + Exercise Program | Experimental | Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program and will also view an educational video explaining TENS. Receives: Device: TENS; Behavioral: TENS educational explanation video; Other: Exercise |
| Active Comparator: TENS + Exercise Program | Active comparator | Participants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program. Receives: Device: TENS; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed using a structured feasibility questionnaire
Feasibility will be evaluated using a structured questionnaire designed to assess the practicality of conducting a future randomized controlled trial (RCT), including aspects such as recruitment, adherence, and data collection. Responses will be summarized descriptively.
Measured: Baseline (Day 1) and 4 weeks post-treatment.
Success rate of obtaining consent from those eligible participants
Number of participants enrolled/randomised
Measured: During the enrolment process
Retention rate of the participants
Retention rate is defined as proportion of people that finished the programme after 4 weeks. Retention data will be assessed based on (i) proportion of participants with complete outcome assessment; (ii) number of discontinuation and reasons.
Measured: Recorded at week 4 at the end of delivering the intervention.
Adherence of the participants
Adherence is defined as the number and proportion of scheduled sessions undertaken by the participants.
Measured: Recorded at week 4 at the end of delivering the intervention.
Secondary outcomes (5)
Pressure Pain Threshold measured using a pressure algometer
Pressure Algometer Device used to assess pain threshold with scores measured with kg/cm², with higher scores indicating greater tolerance to pressure-induced pain.
Measured: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Pain intensity measured using the Visual Analogue Scale (VAS)
A Single-item pain scale to assess pain intensity at rest and during movement before and after intervention (at 3 time points).Scores range from 0 (no pain) to 10 (maximum pain).Higher scores indicate greater pain intensity.
Measured: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Functional disability measured using the Oswestry Disability Index (ODI)
Functional disability related to low back pain was assessed using the Oswestry Disability Index (ODI), a self-reported questionnaire scored from 0 to 100. Higher scores indicate greater disability, with 0 representing no disability and 100 representing maximum disability.
Measured: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Participant satisfaction measured using the Visual Analogue Scale (VAS)
Participant satisfaction will be assessed using a Visual Analogue Scale (VAS). Scores range from 0 (not satisfied at all) to 10 (completely satisfied), with higher scores indicating greater satisfaction with the intervention.
Measured: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Health-related quality of life measured using the 36-Item Short Form Survey (SF-36)
Health-related quality of life was assessed using the 36-Item Short Form Survey (SF-36), which evaluates eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health status and functioning.
Measured: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start5 Apr 2026 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain (LBP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed El Melhat, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535047
- Sponsor's protocol ID
- Placebo Induced Hypoalgesia
- Acronym
- TENS in LBP
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Dyrda A, Bialosky J, Rossettini G. Can pre-treatment verbal suggestions influence the short-term effects of spinal manipulation in young adults with chronic non-specific low back pain? A randomized controlled trial. Musculoskelet Sci Pract. 2025 Nov;80:103431. doi: 10.1016/j.msksp.2025.103431. Epub 2025 Oct 10.
PubMed 41106172Meeuwis SH, Wasylewski MT, Bajcar EA, Bieniek H, Adamczyk WM, Honcharova S, Di Nardo M, Mazzoni G, Babel P. Learning pain from others: a systematic review and meta-analysis of studies on placebo hypoalgesia and nocebo hyperalgesia induced by observational learning. Pain. 2023 Nov 1;164(11):2383-2396. doi: 10.1097/j.pain.0000000000002943. Epub 2023 Jun 15.
PubMed 37326688Ruzic V, Ivanec D, Stanke KM. Effect of expectation on pain assessment of lower- and higher-intensity stimuli. Scand J Pain. 2017 Jan;14:9-14. doi: 10.1016/j.sjpain.2016.09.013. Epub 2016 Oct 27.
PubMed 28850443Peerdeman KJ, van Laarhoven AIM, Keij SM, Vase L, Rovers MM, Peters ML, Evers AWM. Relieving patients' pain with expectation interventions: a meta-analysis. Pain. 2016 Jun;157(6):1179-1191. doi: 10.1097/j.pain.0000000000000540.
PubMed 26945235
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation in Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT07535047
- Acronym / sponsor ID
- TENS in LBP / Placebo Induced Hypoalgesia
- Conditions
- Low Back Pain (LBP), Low Back Pain
- Keywords
- TENS, Transcutaneous Electrical Nerve Stimulation, Placebo, Hypolagesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Apr 2026 (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 primary goal of this clinical trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT), considering recruitment, compliance with study protocols, and adverse events. The secondary goal is to evaluate the effectiveness of a video-based educational explanation of transcutaneous electrical nerve stimulation (TENS) in eliciting placebo-induced hypoalgesia and improving clinical outcomes in patients with acute low back pain.
The main question it aims to answer is: Does the addition of a video-based educational explanation of TENS to standard physical therapy rehabilitation, consisting of TENS and exercises, increase the pressure pain threshold, reduce pain intensity, and improve functional mobility, patient satisfaction, and quality of life in patients with acute low back pain?
Participants will be divided into two groups for comparison: the control group will receive standard physical therapy rehabilitation consisting of TENS and exercises, while the experimental group will receive the same program in addition to the video-based educational explanation of TENS.
Detailed description
Pain modulation through expectation is a well-established phenomenon. Anticipating relief from a treatment can enhance the effects of both pharmacological and non-pharmacological analgesic interventions. The expectation of pain relief can reduce the perceived intensity of stimuli and is associated with changes in brain regions involved in pain processing, including the thalamus, prefrontal cortex, and somatosensory cortices. Previous research suggests that expectation can have a moderate to large effect on experimental and acute procedural pain.
Based on this, the investigators hypothesize that adding a video-based educational explanation of TENS to a standard physical therapy rehabilitation program will enhance patient expectations regarding the intervention. This may elicit placebo-induced hypoalgesia and improve clinical outcomes in patients with acute low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: TENS + Educational Video + Exercise Program | Experimental | Device: TENS, Behavioral: TENS educational explanation video, Other: ExerciseParticipants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program and will also view an educational video explaining TENS. |
| Active Comparator: TENS + Exercise Program | Active comparator | Device: TENS, Other: ExerciseParticipants in this group will receive transcutaneous electrical nerve stimulation (TENS) along with a structured home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute low back pain without radicular pain to lower limbs
- minimal pain level of 4 on the 0-10 VAS
- 18-65 years of age
- TENS naïve or have not used TENS in the past 5 years.
Key exclusion criteria (11 listed)
- Radicular pain to lower limbs
- Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease
- Nerve root disorders confirmed by neurological tests
- Neurological diseases
- Severe cardiorespiratory disease
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 |
|---|---|---|
| TENSAlso: Transcutaneous Electrical Nerve Stimulation12 sessions of TENS each lasting 45 minutes ,will be conducted over a 4-week intervention period . | Device | Active Comparator: TENS + Exercise Program, Experimental: TENS + Educational Video + Exercise Program |
| TENS educational explanation videoThe video provides standardized information on TENS, demonstrating its use, safety, and how it modulates pain through gate control theory | Behavioural | Experimental: TENS + Educational Video + Exercise Program |
| ExerciseParticipants will be provided with a home program consisting of exercises targeting trunk core activation, spinal mobility, and functional movement, as approved by the American Physical Therapy Association (APTA). | Other | Active Comparator: TENS + Exercise Program, Experimental: TENS + Educational Video + Exercise Program |
Primary outcome
Feasibility assessed using a structured feasibility questionnaire
Time frame: Baseline (Day 1) and 4 weeks post-treatment.
Feasibility will be evaluated using a structured questionnaire designed to assess the practicality of conducting a future randomized controlled trial (RCT), including aspects such as recruitment, adherence, and data collection. Responses will be summarized descriptively.
Success rate of obtaining consent from those eligible participants
Time frame: During the enrolment process
Number of participants enrolled/randomised
Retention rate of the participants
Time frame: Recorded at week 4 at the end of delivering the intervention.
Retention rate is defined as proportion of people that finished the programme after 4 weeks. Retention data will be assessed based on (i) proportion of participants with complete outcome assessment; (ii) number of discontinuation and reasons.
Adherence of the participants
Time frame: Recorded at week 4 at the end of delivering the intervention.
Adherence is defined as the number and proportion of scheduled sessions undertaken by the participants.
5 secondary outcomes
Pressure Pain Threshold measured using a pressure algometer
Time frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Pain intensity measured using the Visual Analogue Scale (VAS)
Time frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Functional disability measured using the Oswestry Disability Index (ODI)
Time frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Participant satisfaction measured using the Visual Analogue Scale (VAS)
Time frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
Health-related quality of life measured using the 36-Item Short Form Survey (SF-36)
Time frame: Baseline (Day 1), 4 weeks post-treatment, and 3 months follow-up.
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 16 Apr 2026.
- Background: PubMed 41106172Zaworski K, Baj-Korpak J, Tokarska-Rodak M, Plazuk E, Dyrda A, Bialosky J, Rossettini G. Can pre-treatment verbal suggestions influence the short-term effects of spinal manipulation in young adults with chronic non-specific low back pain? A randomized controlled trial. Musculoskelet Sci Pract. 2025 Nov;80:103431. doi: 10.1016/j.msksp.2025.103431. Epub 2025 Oct 10.
- Background: PubMed 37326688Meeuwis SH, Wasylewski MT, Bajcar EA, Bieniek H, Adamczyk WM, Honcharova S, Di Nardo M, Mazzoni G, Babel P. Learning pain from others: a systematic review and meta-analysis of studies on placebo hypoalgesia and nocebo hyperalgesia induced by observational learning. Pain. 2023 Nov 1;164(11):2383-2396. doi: 10.1097/j.pain.0000000000002943. Epub 2023 Jun 15.
- Background: PubMed 28850443Ruzic V, Ivanec D, Stanke KM. Effect of expectation on pain assessment of lower- and higher-intensity stimuli. Scand J Pain. 2017 Jan;14:9-14. doi: 10.1016/j.sjpain.2016.09.013. Epub 2016 Oct 27.
- Background: PubMed 26945235Peerdeman KJ, van Laarhoven AIM, Keij SM, Vase L, Rovers MM, Peters ML, Evers AWM. Relieving patients' pain with expectation interventions: a meta-analysis. Pain. 2016 Jun;157(6):1179-1191. doi: 10.1097/j.pain.0000000000000540.
- 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.
Ahmed El Melhat, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS, TENS educational explanation video and Exercise in people with Low Back Pain (LBP) and Low Back Pain, run by Cairo 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. 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?
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?
Contact Ahmed El Melhat, PhD (+20 11 12595022, ahmed.elmelhat@cu.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed using a structured feasibility questionnaire (time frame: Baseline (Day 1) and 4 weeks post-treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535047, which also lists 4 linked publications.
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 16 Apr 2026.