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

Diabetic Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06336486
• Other study ID #: BalikesirU-FTR-BG-01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Neuropathic Pain
• Diabetic Neuropathies
• Neuralgia
• Polyneuropathies

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.