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IRCT20221220056877N1 IRCT 2022-12-25 University of Baghdad Effectiveness of Foot Bathing, Massage, and Range of Motion Exercise on patients with Diabetic Peripheral Neuropathy: A Clinical Trial Effectiveness of Foot Bathing, Massage, and Range of Motion Exercise on Diabetic Patients' Peripheral Neuropathy: A Randomized Controlled Trial 2023-01-10 anticipated 100 Complete https://irct.ir/trial/67523 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to maintain a transparent and scientifically based randomization process, stratified randomization will be used in assigning participants (individuals: diabetic patients with peripheral neuropathy) to intervention (foot bathing, foot massage, and range of motion exercise) and control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve choosing a color from a sealed envelope that contains four numbers: blue, yellow, green, and red (blue would be in the foot bathing group, yellow would be in the foot massage group, green would be in the range of motion exercises group, and red would be in the control group). Indeed, four groups will be allocated randomly. N/A Diabetes Mellitus. Intervention 1: Intervention group: After assessing the level of diabetic peripheral neuropathy, the sample will be allocated into four groups: the foot bathing group, which involves immersing both patients' feet in 5 liters of tolerably warm water (between 40 and 45 °C) with 250 grams of powdered mineral salt added and dissolved; the foot massage group, in which the researcher's thumb is used to apply gentle, gradually increasing pressure along the three meridians lines on the feet. Pressure is also applied to the area of the knee in the supine and side-lying positions and to the lower leg, ankle, and foot of the participants. The range-of-motion exercise group combined ROM with plantar exercise and placed a tennis ball for 30 minutes every two days. The active ROM procedure covered flexion-extension-adduction-abduction in the hips and toes, flexion-extension of the knees, dorsiflexion and plantar flexion in the ankles, and inversion-eversion of the legs. Place a tennis ball on the ground and ask patients to gently roll it underfoot, backward and forward, and rotate it along the plantar for five minutes to relax the muscles in the plantar fascia. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after two weeks by using the Toronto Clinical Neuropathy Score. Intervention 2: Control group: The control group received no interventions; instead, they received pre-test and post-test assessments after two weeks, as did the other groups, and they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after two weeks by using the TCNS. Yes - There is a plan to make this available What will be shared: The data will be the results of the TCNS that measure patients' DPN levels in both the control and intervention groups. When: God Willing, once the article is published, the data will be available after 6 months of publication. If the article will be published in a subscribed journal, the data will be available after one year because of the policy of the subscribed journals. To whom: with academic nurses and any researcher who is interested in the data. Conditions: The data could be used after getting permission via email. Also, users need to acknowledge the owner. Where to obtain: Users can ask for the data and permission via email. Taher Al-Fahham is the corresponding author. He will contact whoever he requests the information from. His email is taher.m@uokerbala.edu.iq Taher Al-Fahham works at the University of Kerbala/College of Nursing. The address is Al-Muadhafeen district, Karbala, Iraq. What processes are involved for a request to access data/document How to obtain: Users can ask for the data and permission via email. Taher Al-Fahham is the corresponding author. He will contact whoever he requests the information from. His email is taher.m@uokerbala.edu.iq Comments:
public Taher Mohsin Hashim Al-Fahham
Al-Baladia district
Karbala Iraq 56001 +964 783 906 5883 taher.m@uokerbala.edu.iq University of Kerbala scientific Taher Mohsin Hashim Al-Fahham
Al-Baladia distric
Karbala Iraq 56001 +964 783 906 5883 taher.m@uokerbala.edu.iq University of Kerbala Iraq Patients who are more than or equal to 18 years old Patients who have been diagnosed with diabetes for 10 years and more Patients who have Diabetic Peripheral Neuropathy (DPN) of more than 5 on Toronto Clinical neuropathy score (TCNS) Patients with Type-1 and Type-2 Diabetes Mellitus 18 years no limit Both Patients with score of 5 and less than in TCNS scale Patients who have Chemotherapy-Induced Peripheral Neuropathy Patients with foot gangrene Patients with amputated right or left foot Patients who refused to participate in the study Patients with paralysis, partly or entirely unable to move the affected parts of the body patients with osteoarthritis and osteomyelitis, rheumatoid arthritis Patient with certain viral or bacterial infections, including Lyme disease, shingles, Epstein-Barr virus, hepatitis B and C, leprosy, Diphtheria, and HIV) Patients who are receiving any physiotherapy intervention Patients with inherited disorders, such as Charcot-Marie-Tooth disease are hereditary types of neuropathy; Patients with autoimmune diseases, include lupus, Guillain-Barre syndrome, demyelinating polyneuropathy and vasculitis Patients with bone marrow disorders, These include Multiple myeloma, lymphoma and amyloidosis Patients with other diseases, include kidney and liver disease, connective tissue disorders and hypothyroidism) G90.0 Idiopathic peripheral autonomic neuropathy Treatment - Other Other Intervention group: After assessing the level of diabetic peripheral neuropathy, the sample will be allocated into four groups: the foot bathing group, which involves immersing both patients' feet in 5 liters of tolerably warm water (between 40 and 45 °C) with 250 grams of powdered mineral salt added and dissolved; the foot massage group, in which the researcher's thumb is used to apply gentle, gradually increasing pressure along the three meridians lines on the feet. Pressure is also applied to the area of the knee in the supine and side-lying positions and to the lower leg, ankle, and foot of the participants. The range-of-motion exercise group combined ROM with plantar exercise and placed a tennis ball for 30 minutes every two days. The active ROM procedure covered flexion-extension-adduction-abduction in the hips and toes, flexion-extension of the knees, dorsiflexion and plantar flexion in the ankles, and inversion-eversion of the legs. Place a tennis ball on the ground and ask patients to gently roll it underfoot, backward and forward, and rotate it along the plantar for five minutes to relax the muscles in the plantar fascia. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after two weeks by using the Toronto Clinical Neuropathy Score. Control group: The control group received no interventions; instead, they received pre-test and post-test assessments after two weeks, as did the other groups, and they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after two weeks by using the TCNS. The primary outcome variable is the level of Diabetic Peripheral Neuropathy that can be changed based on foot bathing, foot massage, and ROM exercises. Timepoint: Before intervention and two weeks after intervention. Method of measurement: The Toronto Clinical Neuropathy Score will be used to assess the level of DPN. The author of the trial is the funding source Approved 2022-12-19 Ethics committee in College of Nursing at University of Baghdad Bab-AlMuadham Baghdad Baghdad Iraq