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Completed

NCT Number: NCT06336486

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

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

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Key information

Conditions

Diabetic Neuropathic Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balıkesir University

Balıkesir, Merkez, 10050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

pregabalin group

Other

only pregabalin treatment was continued.

Primary outcomes

  1. The Leeds assessment of neuropathic symptoms and signs(LANSS)

    Time frame: 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.

    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).

  2. Pain quality rating scale(PQAS)

    Time frame: 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.

    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.

  3. Visual Analog Scale(VAS)

    Time frame: 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.

    . 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).

Secondary outcomes

  1. 36-Item Short Form Health Survey(SF-36)

    Time frame: 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.

    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

Sponsors and collaborators

Lead sponsor

Busra Gunes

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 28, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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