Pulsed Electromagnetic Field Therapy for Diabetic Foot Ulcer Sensation
Effect of Low Frequency Pulsed Electromagnetic Field Therapy on Vibration Perception Threshold and Protective Sensation in Diabetic Foot Ulcer
Diabetes Mellitus (DM) is a chronic metabolic disorder characterized by hyperglycaemia for extended periods of time, which causes damage to peripheral nerves, resulting in sensory, motor and autonomic dysfunction. The study will aim to assess the effect of the Low pulse electromagnetic field therapy in VPT and protective sensation in the diabetic foot ulcer. The total number of participants will be 42 (calculated by epi tool) and the participants are to be divided among two groups. Non Probability Consecutive sampling technique will be used for this study.
The data collection tools will be Wagner Classification System for Diabetic Foot Ulcers, Numerical Pain Rating Scale, Goniometry, 10 g monofilament, Tuning Fork 128 Hz will be used. After meeting the inclusion and exclusion criteria and taking the written and verbal informed consent participants in one group will receive (low frequency pulsed electromagnatic field therapy and ankle Range of Motion) and other group will be receive (Sham PEMF and ankle Range of motion). Both interventions will be given three times weekly (or every other day) for 6 weeks. Vibrations perception, protective sensation, pain, ankle ROM and will be the outcome measures of the study. The data will be collected at baseline and 6 weeks. The data will be analyzed by using SPSS 23 and interpreted by using MS Word.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dr. Rubina Zulfqar
- 電話番号：+923414291664
- メール：drrubinazulfqar355@gmail.com
研究場所
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Punjab Province
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Faisalabad、Punjab Province、パキスタン、38000
- 募集
- Dr Rubina Zulfqar
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コンタクト：
- Dr. Rubina Zulfqar
- 電話番号：+923414291664
- メール：drrubinazulfqar355@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Participants must have a clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5) (Bolen et al., 2016).
- Patients with Wagner grade 1 diabetic foot ulcers was selected.
- Michigan Neuropathic Screening Instrument history score ≤7 (Viswanathan et al., 2025).
- Participants showing reduced vibration perception threshold on 128Hz Tunning fork was included to confirm the presence of sensory neuropathy Associated with diabetic ulcers (Viswanathan et al., 2025).
- Sensation on 10g monofilament less then 8 point out of 10 indicate reduces Sensation.
- Participants having diabetes for more than 10 years (Grewal et al., 2015).
- Pariticipants aged between 40 to 60 years.
- Both gender were included.
- Participants who was willing to give consent.
Exclusion Criteria:
- Participants who have significant cognitive impairment (e.g Dementia, Alzheimer) that would prevent them from understanding and adhering to Study instructions.
- Participants with active infections requiring systemic antibiotic therapy (Kwan et al., 2015).
- Patients with comorbidities such as malignancy, severe renal disease, or Other systemic condition.
- Participants who was not taking any medicine
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group A Pulsed Electromagnetic Field Therapy and Ankle Range of Motion
Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Table 2 Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Pulsed Electromagnetic Field Therapy (Tassone et al., 2025) Parameters Description PEMF Low frequency (15 Hz) Very low intensity (20 Gauss) Time duration (20 minutes) Duration 3 days a week (alternate days) Total Treatment Duration 6 weeks Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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実験的：Group B Ankle Range of Motion
Ankle Range of Motion (Levangie and Norkin, 2011) Parameters Description Ankle Range of Motion Active ROM
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Parameters Description Ankle Range of Motion Active ROM
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Vibration Perception Threshold
時間枠：6 week
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Vibration perception threshold will be measured by using Tuning Fork 128 Hz. that check either the patient sense the vibration or not.
if person feel sensation grater than 10 second indicate decrease vibration perception.
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6 week
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Protective Sensation Score as Assessed by the 10-g Monofilament Test (0-10 Total Score).
時間枠：6 weeks
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Protective sensation will be assessed using the 10-g monofilament at 10 standardized plantar sites.
One point is awarded for each site where the participant correctly perceives the monofilament, yielding a total score ranging from 0 to 10. Higher scores indicate better protective sensation.
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6 weeks
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Diabetic peripheral neuropathy
時間枠：6 weeks
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Diabetic peripheral neuropathy will be measured by using Michigan Neuropathy Screening Instrument (MNSI) Physical Assessment, the decrease in score showed improvement the total score consisting of 5 per foot overall 10, 0 indicate foot is healthy and 10 indicate worse condition.
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6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Range of Motion
時間枠：6 weeks
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Range of Motion will be measured by using Goniometory the increase in range shows improvement and decrease showed adverse effect.
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6 weeks
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Pain intensity
時間枠：6 weeks
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Pain intensity will be measured by using Numerical Pain Rating Scale, the scale consisting of 0 to 10 number 0 means no pain 10 mean worse pain the decrease in NPRS scores reflecting decreased pain intensity and increased comfort.
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6 weeks
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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