Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence [14], the goal of the study is to investigate this problem through the following objectives:
There are no clear guidelines for the treatment of peripheral neuropathy. While the American Diabetes Association stresses the importance of early detection and preventive measures, diagnosis and management are still on a developing path.
drugs used have common side effects; duloxetine and pregabalin patients are prone to nausea, fatigue, constipation, and decreased appetite; antidepressants may cause drowsiness, dry mouth, and muscle weakness; and opioids are prevented for long-term use due to the risk of addiction in all chronic cases like peripheral neuropathy. And most of the studies on these medications didn't report quality of life effects.
the lack of clear safe treatments with long-term effects on function and quality of life is the motive to conduct a randomized controlled trial on an objective assessment tool like duplex and a valid and reliable diagnostic tool like the neuropathy impairment score(NIS), measuring the effect of treatment on quality of life by the NORFOLK quality of life questionnaire after treatment with safe nonpharmacological treatment like FREMS therapy.
cases will be referred to the physiotherapy department by a diagnosis of peripheral neuropathy. samples will be assessed and divided into two groups randomly, Group A that will conduct a session with APTIVA FREMS therapy. Group B that will follow the conservative used treatment (doulextine and vitamin supplements) only.
The Number of sessions is 10 sessions consecutively within 10:14 days. The patients will be assessed by full neurological examination through the duplex APSV, neuropathy impairment score and NORFOLK quality of life questionnaire before and after the treatment.
outcomes will be collected by the researcher.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (FREMS group) | Experimental |
| |
| conservative treatment. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| frequency rhythmic electrical modulated stimulation. | Device | FREMS is characterized by sequences of biphasic electrical stimuli, with 10 consecutive sessions applied on lower limb within 10:14 days, 40 minutes for each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathy severity | neuropathy symptoms like (tingling, numbness, pain, loss of sensation) will be measured through neuropathy impairment score(NIS) | From enrollment to the end of treatment at 10:14 days |
| blood perfusion. | effect of FREMS on blood perfusion by duplex. | From enrollment to the end of treatment at 10:14days. |
| Measure | Description | Time Frame |
|---|---|---|
| neuropathy effect in quality of life | neuropathy effect on quality of life by NORFOLK quality of life questionnaire. | From enrollment to the end of treatment at 10:14days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibtihal Nassar, Bsc, Msc. | Contact | +201151678506 | scholaribtihal@gmail.com | |
| Ibtihal Nassar | Contact | 01151678506 | scholaribtihal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ayman abdallah., phd | Beni-Suef University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National diabetes institute | Giza | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29709457 | Background | Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Duloxetine - low dose | Drug | peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days. |
|
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided