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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06336486
Other study ID # BalikesirU-FTR-BG-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2018
Est. completion date February 1, 2020

Study information

Verified date March 2024
Source Balikesir University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated


Description:

The investigators conducted our research from 50 patients with type 2 diabetes of 5-20 years, who received pregabalin treatment with diabetic neuropathy with consent form between 40-75 years.The investigators divided the patients into two equal groups , some of the patients were given an intermittent pneumatic compression program at a pressure of 35 mmhg for 30 min to the lower extremity for 10 days of extreme alternation in our clinic and pregabalin treatment was continued,only pregabalin treatment of the other group was continued. VAS, PQAS, LANSS, SF-36 were evaluated.The evaluation was done before the treatment, at the end of the intermittent pneumatic compression treatment(approximately 2 weeks after the start of the treatment) and 3 months later.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - 5-20 years history of type 2 diabetes - Between the ages of 40-75 - Body mass 25-40 - Blood pressure 100/60-140/90 - Patient diagnosed with diabetic polyneuropathy - Use of pregabalin Exclusion Criteria: - Connective tissue disease - Peripheral nerve vasculitis - Postherpetic neuralgia - Alcoholic neuropathy - Autonomic neuropathy - Chronic renal failure - Charcot-marie tooth disease

Study Design


Intervention

Device:
intermittent pneumatic compression +pregabalin group
The investigators divided the patients into two equal groups , some of the patients were given an intermittent pneumatic compression program at a pressure of 35 mmhg for 30 min to the lower extremity for 10 days of extreme alternation in our clinic and pregabalin treatment was continued.
Other:
pregabalin group
only pregabalin treatment was continued.

Locations

Country Name City State
Turkey Balikesir University Balikesir Merkez

Sponsors (1)

Lead Sponsor Collaborator
Busra Gunes

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Leeds assessment of neuropathic symptoms and signs(LANSS) The Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS) comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.
Out of the seven items in the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS), five are symptom related and two are examination items. On the LANSS Pain Scale, a score of 12 or more was classified as neuropathic pain, and a score under 12 was classified as nociceptive pain. The intensity of pain at the time of interview was recorded on a 10-cm visual analogue scale (VAS) (0, no pain; 10, unbearable pain).
The evaluation was done before the treatment, at the end of the intermittent pneumatic compression treatment(approximately 2 weeks after the start of the treatment) and 3 months later.
Primary Pain quality rating scale(PQAS) The Pain Quality Assessment Scale (PQAS) is an adjusted version of the validated Neuropathic Pain Scale and includes 20 pain qualities and descriptors. PQAS asks respondents to rate the severity of each of 20 pain (quality and spatial) descriptor domains by using 0 to 10 numeric rating scales, in which 0 "no pain" or "not [sensation/item]" and 10 "the most [descriptor] pain sensation imaginable. The evaluation was done before the treatment, at the end of the intermittent pneumatic compression treatment(approximately 2 weeks after the start of the treatment) and 3 months later.
Primary Visual Analog Scale(VAS) . The intensity of pain at the time of interview was recorded on a 10-cm visual analogue scale (VAS) (0, no pain; 10, unbearable pain). The evaluation was done before the treatment, at the end of the intermittent pneumatic compression treatment(approximately 2 weeks after the start of the treatment) and 3 months later.
Secondary 36-Item Short Form Health Survey(SF-36) The SF-36 measures eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health, and has two summary scores (physical and mental).
For each quality of life domain tested, item scores were coded, summed, and transformed into a scale from 0 (worst) to 100 (best) using the standard SF-36 scoring algorithms. Physical and mental summary component scale scores were also calculated using algorithm described by the developers
The evaluation was done before the treatment, at the end of the intermittent pneumatic compression treatment(approximately 2 weeks after the start of the treatment) and 3 months later.
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