Low Back PainNCT07015606
Sciatic Vs Femoral Nerve Mobilization With Electrical Muscle Stimulation for Treatment of Low Back Pain
A study testing Sciatic nerve mobilization with EMS and Femoral neural mobilization with EMS in people with Low Back Pain, run by Shalamar Institute of Health Sciences.
Trial summary
to determine the therapeutic effectiveness of sciatic nerve mobilization compared to femoral nerve mobilization along with electrical stimulation in promoting functional recovery and alleviating symptoms in patients with low back pain and to reveal which one is more effective for pain relief and functional improvement… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Sciatic nerve mobilization with EMS and Femoral neural mobilization with EMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2025to 29 Nov 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-50 years
- Radiating pain pattern
- Muscular pain pattern
- Negative sensory and motor neural examination
- Patients with peripheral nerve sensitization were included if they were adults and had leg pain duration of < 3 months(8)
- VAS Score between 4 and 8
- Positive findings of tests like thigh thrust, Patrick's Faber test, Gaenslen's test, modified Trendelenburg's test and Slump test.
Who cannot join
- Pregnancy
- Post-partum females
- Serious spinal pathology
- Sensory and motor deficient
- History of back and lower extremity surgery
- Patients with contraindication to Electrical Stimulation
- Any serious kind of co-morbidities like malignancy, infections
- Any kind of disability
About this study
Official title: The Comparative Study of Sciatic Vs Femoral Nerve Mobilization Along With Electrical Muscle Stimulation in Low Back Pain
to determine the therapeutic effectiveness of sciatic nerve mobilization compared to femoral nerve mobilization along with electrical stimulation in promoting functional recovery and alleviating symptoms in patients with low back pain and to reveal which one is more effective for pain relief and functional improvement in low back pain patients.
Read the detailed description
Low back pain is a multi-dimensional musculoskeletal condition resulting in discomfort and functional limitation, arising from lower lumbar region radiating towards posterior lower limb or anterior thigh, often resulting from numerous factors like mechanical, degenerative, neuropathic, inflammatory, infectious, neoplastic and psychological factors. One of the most prevalent association of low back pain is nerve irritation and poor neuromuscular coordination. According to nerve pathway and innervation pattern, the main constituents of lumbosacral plexus are sciatic and femoral nerves. Sciatic nerve arises from L4-S3 spinal nerve roots passing through the gluteal region and down the posterior thigh innervating hamstrings, gastrocnemius, soleus, tibialis posterior, flexor digitorum longus, flexor hallucis longus, fibularis longus and brevis. Whereas, femoral nerve originates from L2-L4 and supply along the anterior region of thigh musculature like quadriceps femoris, sartorius, pectineus.
Normal nerve function, reduced mechanical sensitivity, and relief of radiating symptoms are the main goals of neural mobilization. Complementary to this, there are numerous studies which shows the effects of Electrical Muscle Stimulation that reduces pain by maximizes neuromuscular control and activation, facilitates blood circulation and prevents muscular atrophy in low back pain patients.
According to study conducted in 2022 by Romero-Morales and colleagues in Spain, neural mobilization has great effect in management of pain and disability in musculoskeletal disorders. Another study done in Japan in 2023 has describe the efficacy of Neural Mobilization on Pain, Mobility, and Psychosocial Functioning of Patients.
Peripherally neural mobilization increases nerve conductivity and physiologically it changes central sensitization. With an eye towards maximizing functional recovery and pain relief, this comparative study evaluates the combined effects of nerve mobilization and Electrical Stimulation in treatment of Low Back Pain, which has emerging evidence from a study which is published in the journal of pain, USA in 2002 that explains the efficacy of Electrical stimulation with combined therapy .
Another number of studies has also been done explaining the effect of neural mobilization on low back pain one of which is published in Pakistan journal of medical and health sciences in 2022 concluding that sciatic nerve mobilization is an effective treatment for pain and disability in patients.
With a lifetime prevalence in around 80% of adults, low back pain affects approximately 7.5% of the world's population and is the most often reported cause of long term impairment. Recent studies reveal that in Pakistan, particularly among manual laborers, healthcare professionals, and office workers, prevalence of low back pain increases from 30% to 50%.
Poor ergonomics, limited access to rehabilitation and ignorance, all these factors contribute in escalating incidence rate in Pakistan. Evidence based physiotherapeutic interventions are required to reduce the socioeconomic impact of low back pain, which is emerging in importance and is frequently connected with muscular weakness and decreased neural mobility. One of the most commonly reported causes of impairment worldwide is Low back pain that targets the femoral and sciatic nerves, results from mechanical stress on the lumbar plexus.
Techniques of neural mobilization aim to relieve pain, inflammation and normalize nerve mechanics. In addition to being used, it promotes blood circulation, muscle function rehabilitation and supports recovery of neural function. Electrical muscle stimulation aids in both sciatic and femoral nerve mobilizations clinically and direct their therapeutic effect on Low Back Pain. Therapeutic results can be affected by the anatomical and physiological differences between the two nerves. Electrical stimulation and neural mobilization can promote neuromuscular rehabilitation by their synergistic advantages. Finding the best approach makes it possible to have more clinically relevant evidence based therapies for low back pain management. This study aims to provide the evidence based intervention for the effective treatment of low back pain in Pakistan by examining the effectiveness of electrical muscle stimulation alone with sciatic and femoral nerve mobilization.
- Conditions
- Low Back Pain
- Being tested
- Sciatic nerve mobilization with EMS, Femoral neural mobilization with EMS
- Keywords
- Low Back Pain (LBP)
- 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.
Sciatic nerve mobilization with EMSOther
Patients in both groups will receive electrical muscle stimulation. In addition, the group A will receive sciatic neural mobilization and group B will receive femoral neural mobilization. Patients were not allowed to take medication for pain during the study or to receive any other form of treatment outside the study. EMS device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. The frequency of Electrical muscle stimulation and the duration of neural mobilization will be increased after every session up to 10 Hz and 3 mints respectively.
Femoral neural mobilization with EMSOther
Patients in both groups will receive electrical muscle stimulation. In addition, the group A will receive sciatic neural mobilization and group B will receive femoral neural mobilization. Patients were not allowed to take medication for pain during the study or to receive any other form of treatment outside the study. EMS device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. The frequency of Electrical muscle stimulation and the duration of neural mobilization will be increased after every session up to 10 Hz and 3 mints respectively.
| Study group | Role | What they receive |
|---|---|---|
| Sciatic nerve mobilization with Electrical Muscle Stimulation | Other | Each patient will receive therapeutic sessions over 2 weeks (3 sessions per week), with total of 6 sessions. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. Electrical Muscle Stimulation (EMS) device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. Receives: Other: Sciatic nerve mobilization with EMS |
| Femoral neural mobilization with Electrical Muscle Stimulation | Other | Each patient will receive therapeutic sessions over 2 weeks (3 sessions per week), with total of 6 sessions. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. Electrical Muscle Stimulation (EMS) device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. Receives: Other: Femoral neural mobilization with EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
Pain intensity was further measured using the Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). VAS scores were categorized as follows: 0-4 mm indicating no pain, 5-44 mm mild pain, 45-74 mm moderate pain, and 75-100 mm severe pain.21
Measured: 8 WEEKS
Secondary outcomes (3)
Oswestry disability index (ODI)
The Oswestry Disability Index (ODI) is a 10-item, patient-reported questionnaire used to assess functional impairment from lower back pain in both acute and chronic conditions. Disability levels are categorized from minimal to crippling, with scores ranging from 0-100. Each item is scored from 0 to 5, yielding a total score with a cut of ≤50.
Measured: 8 WEEKS
Goniometer for range of motion (ROM)
Using a goniometer is a standard clinical method to assess hip joint mobility through active (patient-driven) or passive (clinician-assisted) movement. Normal ranges include hip flexion (0°-120°), abduction (0°-45°), and extension (0°-30°). Values below 110° for flexion, 35° for abduction, or 20° for extension may indicate functional limitation
Measured: 8 WEEKS
EuroQol 5 Dimension Questionnaire (EQ-5D)
The EQ-5D is a standardized questionnaire used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3- or 5-level scale, generating a health state index. Scores typically range from -0.594 to 1, where 1 indicates full health and <0.5 suggests poor health status. It aids in clinical evaluation, economic analysis, and treatment outcomes.
Measured: 8 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start28 Aug 2025 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion29 Nov 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015606
- Sponsor's protocol ID
- ShalmarIHS
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study of Sciatic Vs Femoral Nerve Mobilization Along With Electrical Muscle Stimulation in Low Back Pain
- ClinicalTrials.gov ID
- NCT07015606
- Acronym / sponsor ID
- ShalmarIHS
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain (LBP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 28 Aug 2025 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 29 Nov 2025 (estimated)
- First posted
- 11 Jun 2025 (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.
to determine the therapeutic effectiveness of sciatic nerve mobilization compared to femoral nerve mobilization along with electrical stimulation in promoting functional recovery and alleviating symptoms in patients with low back pain and to reveal which one is more effective for pain relief and functional improvement in low back pain patients.
Detailed description
Low back pain is a multi-dimensional musculoskeletal condition resulting in discomfort and functional limitation, arising from lower lumbar region radiating towards posterior lower limb or anterior thigh, often resulting from numerous factors like mechanical, degenerative, neuropathic, inflammatory, infectious, neoplastic and psychological factors. One of the most prevalent association of low back pain is nerve irritation and poor neuromuscular coordination. According to nerve pathway and innervation pattern, the main constituents of lumbosacral plexus are sciatic and femoral nerves. Sciatic nerve arises from L4-S3 spinal nerve roots passing through the gluteal region and down the posterior thigh innervating hamstrings, gastrocnemius, soleus, tibialis posterior, flexor digitorum longus, flexor hallucis longus, fibularis longus and brevis. Whereas, femoral nerve originates from L2-L4 and supply along the anterior region of thigh musculature like quadriceps femoris, sartorius, pectineus.
Normal nerve function, reduced mechanical sensitivity, and relief of radiating symptoms are the main goals of neural mobilization. Complementary to this, there are numerous studies which shows the effects of Electrical Muscle Stimulation that reduces pain by maximizes neuromuscular control and activation, facilitates blood circulation and prevents muscular atrophy in low back pain patients.
According to study conducted in 2022 by Romero-Morales and colleagues in Spain, neural mobilization has great effect in management of pain and disability in musculoskeletal disorders. Another study done in Japan in 2023 has describe the efficacy of Neural Mobilization on Pain, Mobility, and Psychosocial Functioning of Patients.
Peripherally neural mobilization increases nerve conductivity and physiologically it changes central sensitization. With an eye towards maximizing functional recovery and pain relief, this comparative study evaluates the combined effects of nerve mobilization and Electrical Stimulation in treatment of Low Back Pain, which has emerging evidence from a study which is published in the journal of pain, USA in 2002 that explains the efficacy of Electrical stimulation with combined therapy .
Another number of studies has also been done explaining the effect of neural mobilization on low back pain one of which is published in Pakistan journal of medical and health sciences in 2022 concluding that sciatic nerve mobilization is an effective treatment for pain and disability in patients.
With a lifetime prevalence in around 80% of adults, low back pain affects approximately 7.5% of the world's population and is the most often reported cause of long term impairment. Recent studies reveal that in Pakistan, particularly among manual laborers, healthcare professionals, and office workers, prevalence of low back pain increases from 30% to 50%.
Poor ergonomics, limited access to rehabilitation and ignorance, all these factors contribute in escalating incidence rate in Pakistan. Evidence based physiotherapeutic interventions are required to reduce the socioeconomic impact of low back pain, which is emerging in importance and is frequently connected with muscular weakness and decreased neural mobility. One of the most commonly reported causes of impairment worldwide is Low back pain that targets the femoral and sciatic nerves, results from mechanical stress on the lumbar plexus.
Techniques of neural mobilization aim to relieve pain, inflammation and normalize nerve mechanics. In addition to being used, it promotes blood circulation, muscle function rehabilitation and supports recovery of neural function. Electrical muscle stimulation aids in both sciatic and femoral nerve mobilizations clinically and direct their therapeutic effect on Low Back Pain. Therapeutic results can be affected by the anatomical and physiological differences between the two nerves. Electrical stimulation and neural mobilization can promote neuromuscular rehabilitation by their synergistic advantages. Finding the best approach makes it possible to have more clinically relevant evidence based therapies for low back pain management. This study aims to provide the evidence based intervention for the effective treatment of low back pain in Pakistan by examining the effectiveness of electrical muscle stimulation alone with sciatic and femoral nerve mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sciatic nerve mobilization with Electrical Muscle Stimulation | Other | Other: Sciatic nerve mobilization with EMSEach patient will receive therapeutic sessions over 2 weeks (3 sessions per week), with total of 6 sessions. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. Electrical Muscle Stimulation (EMS) device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. |
| Femoral neural mobilization with Electrical Muscle Stimulation | Other | Other: Femoral neural mobilization with EMSEach patient will receive therapeutic sessions over 2 weeks (3 sessions per week), with total of 6 sessions. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. Electrical Muscle Stimulation (EMS) device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 20-50 years
- Radiating pain pattern
- Muscular pain pattern
- Negative sensory and motor neural examination
- Patients with peripheral nerve sensitization were included if they were adults and had leg pain duration of < 3 months(8)
Key exclusion criteria (8 listed)
- Pregnancy
- Post-partum females
- Serious spinal pathology
- Sensory and motor deficient
- History of back and lower extremity surgery
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 |
|---|---|---|
| Sciatic nerve mobilization with EMSPatients in both groups will receive electrical muscle stimulation. In addition, the group A will receive sciatic neural mobilization and group B will receive femoral neural mobilization. Patients were not allowed to take medication for pain during the study or to receive any other form of treatment outside the study. EMS device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. The frequency of Electrical muscle stimulation and the duration of neural mobilization will be increased after every session up to 10 Hz and 3 mints respectively. | Other | Sciatic nerve mobilization with Electrical Muscle Stimulation |
| Femoral neural mobilization with EMSPatients in both groups will receive electrical muscle stimulation. In addition, the group A will receive sciatic neural mobilization and group B will receive femoral neural mobilization. Patients were not allowed to take medication for pain during the study or to receive any other form of treatment outside the study. EMS device was applied at a pulse frequency of 100 Hz. Placement of 2 surface electrodes will be used for stimulation over a session period of 15 minutes. The repetition of mobilization will be 10 times for 2 sets with 2 minutes rest in between the sets. The frequency of Electrical muscle stimulation and the duration of neural mobilization will be increased after every session up to 10 Hz and 3 mints respectively. | Other | Femoral neural mobilization with Electrical Muscle Stimulation |
Primary outcome
Visual analog scale (VAS)
Time frame: 8 WEEKS
Pain intensity was further measured using the Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). VAS scores were categorized as follows: 0-4 mm indicating no pain, 5-44 mm mild pain, 45-74 mm moderate pain, and 75-100 mm severe pain.21
3 secondary outcomes
Oswestry disability index (ODI)
Time frame: 8 WEEKS
Goniometer for range of motion (ROM)
Time frame: 8 WEEKS
EuroQol 5 Dimension Questionnaire (EQ-5D)
Time frame: 8 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 15 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sciatic nerve mobilization with EMS and Femoral neural mobilization with EMS in people with Low Back Pain, run by Shalamar Institute of Health Sciences.
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 8 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: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Visual analog scale (VAS) (time frame: 8 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 15 Jun 2025.