The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality

April 13, 2025 updated by: Fatma Gündüz Oruç, Giresun University

The Effect of Acupressure on Polyneuropathy-related Pain and Sleep Quality in Patients With Type 2 Diabetes

This study aimed to determine the effect of acupressure on polyneuropathy-related pain and sleep quality in patients with type 2 diabetes. A randomized controlled experimental design was employed in the study. The study sample consisted of 86 patients with type 2 diabetes (44 in the acupressure group and 42 in the control group) who met the inclusion criteria and agreed to participate. Participants were randomly assigned to either the experimental or control group. The experimental group received six sessions of acupressure over six consecutive days, while the control group received no intervention. Data were collected using a personal information form, the Pain Quality Assessment Scale (PQAS), and the Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were conducted using SPSS for Windows 22. Acupressure was found to reduce polyneuropathy-related pain and enhance sleep quality in patients with type 2 diabetes. Therefore, acupressure may be considered an alternative nursing intervention for individuals with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25000
        • Endocrinology Clinic and Outpatient Clinic of a Atatürk University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Were between the ages of 18-65 years old
  • Resided in the city center
  • Had no additional diseases that could cause sensory neuropathy, such as peripheral arterial disease, peripheric vein disease, nervous system diseases, benign or malign tumor, chemotherapy history, carpal tunnel syndrome, and arthritis.
  • Had no clotting or bleeding disorders
  • Were not undergoing dialysis treatment during the study period
  • Had no ulcers, physical deformities or foot calluses
  • Had no history of analgesic medication, except for medication used for DPN
  • Had no physical diseases, cognitive deficiencies or psychiatric disease diagnosis that would prevent understanding of the questions on the scales used for data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure group
Particiants in this group received acupressure application.
Other: Acupressure
Acupressure is a noninvasive type of acupuncture. It is applied using fingers, joints or a suitable acupressure tool.
No Intervention: Control group
Participants in this group did not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Quality Assessment Scale (PQAS)
Time Frame: 6 days
This scale was originally developed by Galer et al. as the Neuropathic Pain Scale and its validity was confirmed with multiple sclerosis patients (Galer&Jensen 1997). However, this original scale does not include allodynia and paroxysmal pain characteristics, which are common in neuropathic pain syndromes. Jensen et al. developed the Pain Quality Assessment Scale (PQAS) by adding 10 items related to the quality of neuropathic pain, and its validity was confirmed by measuring the neuropathic pain due to carpal tunnel syndrome (Cronbach's alpha 0.87-0.98) (Jense et al.,2006). Şahin et al. adapted the final version of the scale for Turkish society and reported that it is reliable to be used for the cases of diseases with neuropathic pain (Şahin et al., 2010). For the PQAS, it is recommended that no total score be calculated; rather, the three subscales are scored from 0 to 10. In this study, the Cronbach's alpha values were 0.836 for the paroxysmal pain subscale, 0.624 for the surface pa
6 days
Pittsburgh Quality of Sleep Index (PQSI)
Time Frame: 6 days
This questionnaire was developed by Buysse et al. and was confirmed to have a high internal consistency (Cronbach's alpha=0.75), test-retest reliability, and validity (Buyyse et al., 1989). A study was conducted to confirm the Turkish validity and reliability of the questionnaire (Cronbach alpha=0.660) (Ağargün&Anlar 1996). Each item of the questionnaire is scored between 0 and 3, and the total PQSI score, which ranges between 0 and 21, is obtained by adding the subscale scores. A PSQI score between 0 and 4 indicates a good quality of sleep, while a score between 5 and 21 indicates a bad quality of sleep (Ağargün&Anlar 1996). In the present study, Cronbach's alpha value was 0.576 for the total PSQI.
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Investigators

  • Study Director: Elanur YILMAZ KARABULUTLU Professör, pHD, Erzurum Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Actual)

June 15, 2019

Study Completion (Actual)

July 12, 2019

Study Registration Dates

First Submitted

April 13, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 13, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRU-SBF-FGO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I do not want my data to be used by other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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