the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy

NCT ID: NCT06336486

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-02-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Diabetic Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups with a conventional therapy control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intermittent pneumatic compression +pregabalin

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.

Group Type ACTIVE_COMPARATOR

intermittent pneumatic compression +pregabalin group

Intervention Type DEVICE

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.

pregabalin

only pregabalin treatment was continued.

Group Type OTHER

pregabalin group

Intervention Type OTHER

only pregabalin treatment was continued.

Interventions

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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.

Intervention Type DEVICE

pregabalin group

only pregabalin treatment was continued.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Busra Gunes

OTHER

Sponsor Role lead

Responsible Party

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Busra Gunes

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nilay Şahin, Prof.

Role: STUDY_DIRECTOR

Balikesir University

Locations

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Balıkesir University

Balıkesir, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BalikesirU-FTR-BG-01

Identifier Type: -

Identifier Source: org_study_id

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