Lateral Cutaneous Nerve of Thigh LesionNCT05665413
Stroking Versus Ergon Technique in Pregnant Women
A study testing TENS in people with Lateral Cutaneous Nerve of Thigh Lesion, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will focus on non-invasive management options for radiculopathy and functional activity in 3rd trimester women due to lateral cutaneous femoral nerve study. The findings of this study will help future clinicians to develop management plans for these patients that can include non-invasive and… Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Lateral Cutaneous Nerve of Thigh Lesion
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Dec 2021to Feb 2023
- Phase
- Interventional
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant ladies during 3rd trimester.
- Pregnant ladies of age between 30 to 40 years.
- Primigravida and Multigravida ladies.
Who cannot join
- Pregnant ladies with any previous hip fracture.
- Women with high risk pregnancy.
- Any previous history of disc herniation.
- Patients with lumbar radiculopathy.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Surya Azeem Hospital
Lahore, Punjab Province, 54000
dr.fatima tariq, TDPT, 03344255033, fatima.tariq@riphah.edu.pk
Fatima Tariq, TDPT
About this study
Official title: Effects of Stroking Versus Ergon Technique on Lateral Cutaneous Femoral Nerve Radiculopathy and Functional Activity in Pregnant Women
The study will focus on non-invasive management options for radiculopathy and functional activity in 3rd trimester women due to lateral cutaneous femoral nerve study. The findings of this study will help future clinicians to develop management plans for these patients that can include non-invasive and non-pharmacological treatment options like Ergon Technique and Stroking based on their effectiveness. The lateral femoral cutaneous nerve is formed by posterior divisions of the anterior rami of spinal nerves to enter the iliac fossa. It continues into the anterolateral thigh by passing either below or through the inguinal ligament, emerging anterior to the Sartorius muscle L2 and L3 In the thigh, it gives rise to two branches, The anterior branch supplies the skin of the anterolateral thigh to the knee and the posterior branch innervates the skin of the lateral aspect of the greater trochanter to the mid-thigh region. It can be compressed due to swelling, trauma or pressure in the surrounding areas. Common causes may include: Tight clothing, obesity or weight gain, and pregnancy. Symptoms may include anterior and lateral thigh burning, tingling, and numbness.
It will be a randomized clinical trial aimed to find the comparative effects of stroking and ergon technique on radiculopathy and functional activity in pregnant women. Women who meet the inclusion criteria that is they show positive femoral traction test, two point discrimination, light touch and pin prick maneuver will be recruited from Surya Azeem Hospital and Jinnah Hospital, Lahore. Two groups will be formed 13 patients will be allocated in each group. Before applying the techniques pre treatment reading will taken after that Hot Pack and TENS will be applied as a baseline treatment to both groups while Ergon technique will be applied to group A while stroking will be applied to the patients of group B. Two sessions per week will be given for 8 weeks. After that post treatment reading will be taken on 8th week. Data will be analyzed by using SPSS for windows version 25
- Conditions
- Lateral Cutaneous Nerve of Thigh Lesion
- Being tested
- TENS
- Keywords
- numbness, thigh, pain
- Medical subject headings
- Hypesthesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called HOT PACK, Ergon instrument, strocking technique
strocking technique, HOT PACK and Ergon instrument
| Study group | Role | What they receive |
|---|---|---|
| strocking technique | Experimental | Not described Receives: Device: TENS |
| ergon technique | Experimental | Not described Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain DETECT questionnaire PDQ
painDETECT (PDQ) is a symptom-based assessment tool. It is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. Total scoring is 35.
Measured: 8th week
The Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.Total scoring is 80.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start24 Dec 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Cutaneous Nerve of Thigh LesionStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fatima tariq, TDPT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665413
- Sponsor's protocol ID
- REC/22/0542 Sadaf Anjum
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2022
- Last updated
- 27 Dec 2022
- 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 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stroking Versus Ergon Technique on Lateral Cutaneous Femoral Nerve Radiculopathy and Functional Activity in Pregnant Women
- ClinicalTrials.gov ID
- NCT05665413
- Acronym / sponsor ID
- REC/22/0542 Sadaf Anjum
- Conditions
- Lateral Cutaneous Nerve of Thigh Lesion
- Keywords
- numbness, thigh, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 27 Dec 2022 (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 study will focus on non-invasive management options for radiculopathy and functional activity in 3rd trimester women due to lateral cutaneous femoral nerve study. The findings of this study will help future clinicians to develop management plans for these patients that can include non-invasive and non-pharmacological treatment options like Ergon Technique and Stroking based on their effectiveness. The lateral femoral cutaneous nerve is formed by posterior divisions of the anterior rami of spinal nerves to enter the iliac fossa. It continues into the anterolateral thigh by passing either below or through the inguinal ligament, emerging anterior to the Sartorius muscle L2 and L3 In the thigh, it gives rise to two branches, The anterior branch supplies the skin of the anterolateral thigh to the knee and the posterior branch innervates the skin of the lateral aspect of the greater trochanter to the mid-thigh region. It can be compressed due to swelling, trauma or pressure in the surrounding areas. Common causes may include: Tight clothing, obesity or weight gain, and pregnancy. Symptoms may include anterior and lateral thigh burning, tingling, and numbness.
It will be a randomized clinical trial aimed to find the comparative effects of stroking and ergon technique on radiculopathy and functional activity in pregnant women. Women who meet the inclusion criteria that is they show positive femoral traction test, two point discrimination, light touch and pin prick maneuver will be recruited from Surya Azeem Hospital and Jinnah Hospital, Lahore. Two groups will be formed 13 patients will be allocated in each group. Before applying the techniques pre treatment reading will taken after that Hot Pack and TENS will be applied as a baseline treatment to both groups while Ergon technique will be applied to group A while stroking will be applied to the patients of group B. Two sessions per week will be given for 8 weeks. After that post treatment reading will be taken on 8th week. Data will be analyzed by using SPSS for windows version 25
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strocking technique | Experimental | Device: TENS |
| ergon technique | Experimental | Device: TENS |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant ladies during 3rd trimester.
- Pregnant ladies of age between 30 to 40 years.
- Primigravida and Multigravida ladies.
Key exclusion criteria (4 listed)
- Pregnant ladies with any previous hip fracture.
- Women with high risk pregnancy.
- Any previous history of disc herniation.
- Patients with lumbar radiculopathy.
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: HOT PACK, Ergon instrument, strocking techniquestrocking technique, HOT PACK and Ergon instrument | Device | ergon technique, strocking technique |
Primary outcome
Pain DETECT questionnaire PDQ
Time frame: 8th week
painDETECT (PDQ) is a symptom-based assessment tool. It is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. Total scoring is 35.
The Lower Extremity Functional Scale (LEFS)
Time frame: 8th week
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.Total scoring is 80.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: No
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.
fatima tariq, TDPT study chair
Riphah International 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 in people with Lateral Cutaneous Nerve of Thigh Lesion, run by Riphah International University at 1 site in Pakistan.
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 27 Dec 2022. 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 Pakistan. 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 Sadaf Anjum, MS-WHPT (03404676735, sadaf.anjum10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain DETECT questionnaire PDQ (time frame: 8th week). The study lists 2 primary outcomes in all. 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 27 Dec 2022.