Clinical trial NCT06336486: the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy
Official title: Comparison of the Effectiveness of Pregabalin Therapy on Neuropathic Pain in Patients With Diabetic Polyneuropathy and the Treatments Applied in Patients Receiving Pregabalin and Intermittent Pneumatic Compression Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathic Pain
Keywords: Intermittent pneumatic compression
Diabetic Neuropathy
Pain Measurements
Quality of life
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with a conventional therapy control group
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Leeds assessment of neuropathic symptoms and signs(LANSS)
timeFrame: 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.
measure: Pain quality rating scale(PQAS)
timeFrame: 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.
measure: Visual Analog Scale(VAS)
timeFrame: 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 outcomes:
measure: 36-Item Short Form Health Survey(SF-36)
timeFrame: 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.
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Balıkesir University
state: Merkez
Study officials:
affiliation: Balikesir University
name: Nilay Şahin, Prof.
role: STUDY_DIRECTOR
References: