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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05670600
Other study ID # Gaziüniversite
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 19, 2021
Est. completion date September 13, 2021

Study information

Verified date January 2023
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.


Description:

In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
foot and ankle exercise
Foot and Ankle Exercise Phase Pulling the foot upwards from the ankle Bending the foot down from the ankle Spreading the feet like a fan, moving the toes in and out to the right and left Circle drawing exercise with ankle Towel folding exercise Bottle rolling exercise under the feet (The water in the bottle will be warm tap water)

Locations

Country Name City State
Turkey Toros Devlet Hastanesi Mersin

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain level at 4th and 8th weeks compared to baseline. Pain scores of the patients were checked after foot and ankle exercise training. The scale, developed by Price, McGrath, Rafii, and Buckingham, is a measurement tool that evaluates pain severity. The scale is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The marked numerical value indicates the severity of the patient's perception of pain. A VAS value of 1 to 4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. As scores increase, the level of pain worsens and general health deteriorates. Two months
Secondary Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state After the interventions, the patient's scores on the effect of neuropathic pain on quality of life are checked. Poole, Murphy, and Nurmka (2009) developed a questionnaire on the impact of neuropathic pain on quality of life. The scale consisting of 42 items; symptoms were divided into 6 subscales under the headings of relationships, psychological, social activity, physical activity, and personal/self care. The results of the questionnaire on the effect of neuropathic pain on the quality of life were calculated by summing the 42-item scores. The total score range is between 42 and 210. The score range for each item is between 1 and 5. Two months
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