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High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients 60

募集中
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治験番号 NCT06822218 は 介入研究 臨床試験 で、糖尿病 に関するものです。現在は 募集中 で、2023年1月1日 から開始しています。60 名の参加者 の募集が計画されています。この試験は カイロ大学 によって主導され、2025年2月28日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年2月12日 です。
概要
the results of this study may provide an easy non pharmacological modality for dealing with diabetic polyneuropathic pain. Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of diabetic polyneuropathy. In Addition,...もっと見る
詳細説明
This study will be carried out on sixty diabetic male patients with polyneuropathy with ages 50-60 years . Patient will be randomly assigned to two grouos. group A will include 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be intr...もっと見る
公式タイトル

High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients

疾患名
糖尿病
その他の研究識別子
  • P.T/REC/012/003905
NCT番号
NCT06822218
開始日
2023-01-01
最終更新日
2025-02-12
終了予定日
2025-02-28
目標参加者数
60
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
参加グループ/群介入/治療法
実験的High tone power therapy
30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy
high tone power therapy
patients will be assigned into 2 groups with pre and post treatment protocol application. all patients will be thoroughly evaluated before and after treatment protocol application.
実薬対照薬TENS
30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS
TENS
These patients will receive TENS with applied frequencies range from 2 to 120 Hz. for 3 times per week for 30 minutes every session during 3 months of intervention in addition to medications.
主要評価項目
評価指標指標の説明時間枠
Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)
t is a questionnaire has been developed to facilitate detection of neuropathic pain.total score is 10 .diagnosis of neuropathic pain is 4/10.
up to 12 weeks
Pain pressure threshold algometer
devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure
up to 12 weeks
副次評価項目
評価指標指標の説明時間枠
Glyclated Haemoglobin Level (HbA1c)
Increasing HbA1c level is significantly associated with increased prevalence of DPN as well as PDPN and non-painful DPN
up to 12 weeks
life disability
the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) is an abbreviated, 26-item version of the 100-item WHOQOL-100 quality of life measure. The WHOQOL-BREF addresses four quality of life domains: physical health, psychological health, social relationships and environment. Then calculate a domain score for each of the health domains by calculating the average answer points for each domain (sum of answer points divided by number of questions) and multiplying the result by the number 4.
up to 12 weeks
参加アシスタント
適格基準

対象年齢
成人
試験の最低年齢
50 Years
対象性別
男性

  • The patient selection will be according to the following criteria:

    1. Sixty male patients are diagnosed with diabetic polyneuropathy their ages will be ranged from 50-60 years old.
    2. All patients are ambulant independently.
    3. All patients are under full medical control
    4. HbA1c is ranged from 6.5 : 7 %.
    5. Patients has diabetes more than 10 years.

  • The participants will be excluded if they meet one of the following criteria:

    1. Psychiatric disorders or seizures.
    2. Visual and auditory impairment or tremors influencing balance.
    3. Other neuromuscular disorders.
    4. Foot deformities and ulcers.
    5. Lower limb operations.
    6. Feverish systemic infection
    7. cardiac pacemaker.
Cairo University logoカイロ大学1117 件のアクティブな治験を探索
責任者
Zeinab Mahmoud Awad Allah, 主任研究者, senior of physiotherapy, Cairo University
試験中央連絡先
連絡先: zeinab Awadallah, master, +201285819342, [email protected]
連絡先: Alaa El-Moatasem, lecturer, 01006625054, [email protected]
1 1カ国の場所
Om Elmasryeen Genral Hospital, Giza, Egypt
zeinab Awadallah, 連絡先, +201285819342, [email protected]
募集中