Meralgia ParestheticaMETNCT04747119
Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique"
A study testing muscle energy technique and conventional selected physical therapy in people with Meralgia Paresthetica and Femoral Neuropathy, run by October 6 University at 1 site in Egypt.
Trial summary
To investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the postpartum female which results in pain and less physical activities. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Meralgia Paresthetica, Femoral Neuropathy
- What is being tested?
- muscle energy technique and conventional selected physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 30 Jan 2021
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Thirty meralgia paraesthesia postpartum female Patients
- with positive Pelvic compression test
- age ranging from 25:40 years
- post vaginal delivery or post-operative (postpartum) persistent dysthesia in anterolateral thigh (one side or both)
- body mass index (20:29.9) Kg/m2
Who cannot join
- difficulty to communicate or to understand program instructions
- other conditions that caused pain (for example fibromyalgia and arthritis)
- any psychiatric or cognitive symptoms any other musculoskeletal disorders or neurologic diseases of the lower extremities and spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Muscle Energy Technique on Femoral Meralgia Paraesthesia in Postpartum: A Randomized Controlled Trial
To investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the postpartum female which results in pain and less physical activities.
………HYPOTHESES:
This study hypothesized that:
muscle energy technique will have a significant effect on Femoral meralgia paraesthesia in postpartum female
Read the detailed description
Thirty meralgia paraesthesia postpartum females will participate in this study.
The patients will randomly be divided into two equal groups; the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique, three times per week for four weeks.
The evaluation methods by Femoral nerve conduction velocity will be measured via the Neuropack S1 MEB9004 EMG device before the exercise program and after finishing the exercise program, and also the Pelvic compression test and Pain numeric rating scale
- Conditions
- Meralgia Paresthetica, Femoral Neuropathy
- Being tested
- muscle energy technique, conventional selected physical therapy
- Medical subject headings
- Femoral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle energy techniqueOther
the patient was supine and the therapist fix the lower limb of the affected side then ask the patient to perform isometric contraction for abductors maintained for 3-5 seconds, then the patient was instructed to stop, exhale and relax then the therapist perform further adducted the patient's knee of the affected side as a stretching exercise for Three to five repetitions of these directions were performed.
conventional selected physical therapyOther
- life style modification
- Transcutaneous electrical nerve stimulation (TENS)
- Flexibility stretching exercises to the hip flexors
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | received the conventional selected exercise program in addition to muscle energy technique Receives: Other: muscle energy technique; Other: conventional selected physical therapy |
| control group | Experimental | received the conventional selected exercise program Receives: Other: conventional selected physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral nerve conduction latency
Femoral nerve conduction latency measured via the Neuropack S1 MEB9004 EMG device
Measured: 4 weeks
Secondary outcomes (2)
Pelvic compression test
the therapist applied a downward compression force to the pelvis and maintained a pressure for 45 seconds. If the patients reported an alleviation of symptoms the test is considered positive
Measured: four weeks
Numeric Pain Rating Scale (NPRS)
it includes 11-point numeric scale ranges from no pain with score of "0" to worst pain imaginable with score of "10"
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Oct 2020
- Primary completion30 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meralgia ParestheticaStudies 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
- Model description
- the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
- Investigators
- Lama Saad Mahmoud, PHD, Study chair, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747119
- Sponsor's protocol ID
- P.T. REC/012/002864
- Acronym
- MET
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 10 Feb 2021
- 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Muscle Energy Technique on Femoral Meralgia Paraesthesia in Postpartum: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04747119
- Acronym / sponsor ID
- MET / P.T. REC/012/002864
- Conditions
- Meralgia Paresthetica, Femoral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 10 Feb 2021 (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 investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the postpartum female which results in pain and less physical activities.
………HYPOTHESES:
This study hypothesized that:
muscle energy technique will have a significant effect on Femoral meralgia paraesthesia in postpartum female
Detailed description
Thirty meralgia paraesthesia postpartum females will participate in this study.
The patients will randomly be divided into two equal groups; the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique, three times per week for four weeks.
The evaluation methods by Femoral nerve conduction velocity will be measured via the Neuropack S1 MEB9004 EMG device before the exercise program and after finishing the exercise program, and also the Pelvic compression test and Pain numeric rating scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: muscle energy technique, Other: conventional selected physical therapyreceived the conventional selected exercise program in addition to muscle energy technique |
| control group | Experimental | Other: conventional selected physical therapyreceived the conventional selected exercise program |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Thirty meralgia paraesthesia postpartum female Patients
- with positive Pelvic compression test
- age ranging from 25:40 years
- post vaginal delivery or post-operative (postpartum) persistent dysthesia in anterolateral thigh (one side or both)
- body mass index (20:29.9) Kg/m2
Key exclusion criteria (3 listed)
- difficulty to communicate or to understand program instructions
- other conditions that caused pain (for example fibromyalgia and arthritis)
- any psychiatric or cognitive symptoms any other musculoskeletal disorders or neurologic diseases of the lower extremities and spine
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 |
|---|---|---|
| muscle energy techniquethe patient was supine and the therapist fix the lower limb of the affected side then ask the patient to perform isometric contraction for abductors maintained for 3-5 seconds, then the patient was instructed to stop, exhale and relax then the therapist perform further adducted the patient's knee of the affected side as a stretching exercise for Three to five repetitions of these directions were performed. | Other | study group |
| conventional selected physical therapy1. life style modification 2. Transcutaneous electrical nerve stimulation (TENS) 3. Flexibility stretching exercises to the hip flexors | Other | control group, study group |
Primary outcome
Femoral nerve conduction latency
Time frame: 4 weeks
Femoral nerve conduction latency measured via the Neuropack S1 MEB9004 EMG device
2 secondary outcomes
Pelvic compression test
Time frame: four weeks
Numeric Pain Rating Scale (NPRS)
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Meralgia Paresthetica
Enrolling by invitation
Percussive vs. Gentle Massage for Recovery After Hip Replacement
Paresthesia, Total Hip Arthroplasty (THA)
Recruiting
The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica
Meralgia Paresthetica
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.
Lama Saad Mahmoud, PHD study chair
October 6 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 muscle energy technique and conventional selected physical therapy in people with Meralgia Paresthetica and Femoral Neuropathy, run by October 6 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 5 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: finished, as of the sponsor's last update on 10 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Femoral nerve conduction latency (time frame: 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 10 Feb 2021.