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

NCT06336486 | Completed

• 1 other identifier: BalikesirU-FTR-BG-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Neuropathic Pain

Keywords

Intermittent pneumatic compression; Diabetic Neuropathy; Pain Measurements; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• 36-Item Short Form Health Survey(SF-36)

  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.

Study Arms (2)

intermittent pneumatic compression +pregabalin

ACTIVE COMPARATOR

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.

Device: intermittent pneumatic compression +pregabalin group

pregabalin

OTHER

only pregabalin treatment was continued.

Other: pregabalin group

Interventions

intermittent pneumatic compression +pregabalin group 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.

intermittent pneumatic compression +pregabalin

pregabalin group OTHER

only pregabalin treatment was continued.

pregabalin

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Connective tissue disease
• Peripheral nerve vasculitis
• Postherpetic neuralgia
• Alcoholic neuropathy
• Autonomic neuropathy
• Chronic renal failure
• Charcot-marie tooth disease

Sponsors & Collaborators

• Busra Gunes: lead

Study Sites (1)

Balıkesir University

Balıkesir, Merkez, 10050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Nilay Şahin, Prof.

  Balikesir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two groups with a conventional therapy control group

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 28, 2024
• Study Start: December 4, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)