A Trial for the Use of a Pulsed Electromagnetic Field Device to Assist Management of Type 2 Diabetes

NCT04884425 | Unknown

• 1 other identifier: SMU_ETHICS_2020-21_157
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of people with diabetes worldwide consist of type 2 diabetes mellitus. Typically, patients with type 2 diabetes are encouraged to manage their condition with weight loss; healthy eating; regular exercise; blood glucose monitoring; and in some cases, diabetes medication or insulin therapy. However, many struggle with their condition. Pulsed Electromagnetic Frequency (PEMF) devices, which follow similar principles as a TENS machine, emit electromagnetic fields and are proposed to provide a non-invasive, safe, and easy-to-use method for treatment and management of diabetes related symptoms such as pain, alongside existing treatments and interventions. There is a belief that such devices may promote health and wellbeing and as a result could improve outcomes of type 2 diabetes. The use of the PEMF device would not replace existing treatments, interventions, or any primary care that the participants are currently receiving. The purpose of this study is to evaluate the effectiveness of a PEMF device of this kind for reported symptoms such as pain, fatigue, and overall wellbeing in people with type 2 diabetes. The study also seeks to explore patients' experiences of using the PEMF device.

Conditions

Type 2 Diabetes

Keywords

Pulsed Electromagnetic Frequency Device; Diabetic Pain

Outcome Measures

Primary Outcomes (3)

• Change in score of the Appraisal of Diabetes Scale (ADS)

  Appraisal of Diabetes Scale (ADS): The ADS is a brief 7-item patient-reported scale that assesses the impact of diabetes on a patient's life. The items, which were developed based on theory and previous research, include "How upsetting is having diabetes for you?" and "To what degree does your diabetes get in the way of your developing life goals?". The instrument has been shown to have acceptable internal consistency reliability, test-retest reliability, and construct validity. Higher scores indicate greater negative impact of diabetes.

  Baseline and at the end of the 3 months

• Change in Measure Yourself Medical Outcome Profile (MYMOP)2 score

  MYMOP2 is a validated questionnaire where patients can express their any two concerns and rate them

  Baseline and at the end of the 3 months

• Change in the EQ-5D-5L tool score

  EQ-5D-5L: Health related quality of life (HRQoL) will be measured using the EQ-5D-5L, which contains five indices to represent patients' HRQoL on the day of completing the form: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. The EQ-5D-5L also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL. The EQ-5D-5L is well validated and numerous studies have used the EQ-5D-5L in a variety of patient populations, including diabetes.

  Baseline and at the end of the 3 months

Study Arms (2)

PEMF Device Group

ACTIVE COMPARATOR

This arm will consist of participant's who have been randomly assigned to use the PEMF device daily for 30 mins for an overall 3 months

Device: Pulsed Electromagnetic Frequency Device (Energy5)

Waiting List Control Group

NO INTERVENTION

These participants will be randomly selected to be on the waiting list group. All waiting list participants will be offered the use of the PEMF device after the study has completed

Interventions

Pulsed Electromagnetic Frequency Device (Energy5) DEVICE

A pulsed electromagnetic frequency (PEMF) device which is recommended to be used for 30 minutes a day

Also known as: Energy5

PEMF Device Group

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years, of any gender.
• Consulted at their general practice for type 2 diabetes in the previous 12 months.
• Residing within England (due to delivery difficulties from covid-19).
• Self-reported confirmed diagnosis of type 2 diabetes.
• Self-reported stable medication regime for diabetes for at least one month.
• Sufficient command of English to complete questionnaires.
• Patients willing to participate in the study and be randomised into one of the two study groups.

You may not qualify if:

• Patients with type 1 diabetes.
• Patients with previous experience of using PEMF devices.
• Patients residing outside England.
• Patients with electronic implants such as pacemakers.
• Patients with an electro-cardio implant.
• Patients who have any electronic heart or lung apparatus.
• Patients who are pregnant.
• Patients who have a malignant tumour.
• Patients who are receiving high-level treatment.
• Patients who have a life-threatening illness.

Sponsors & Collaborators

• St Mary's University College: lead
• Energy5 Limited: collaborator

Study Sites (1)

St Marys University

Twickenham, Middlesex, TW1 4SX, United Kingdom

Location

Related Publications (8)

• Adu MD, Malabu UH, Malau-Aduli AEO, Malau-Aduli BS. Enablers and barriers to effective diabetes self-management: A multi-national investigation. PLoS One. 2019 Jun 5;14(6):e0217771. doi: 10.1371/journal.pone.0217771. eCollection 2019.

  PMID: 31166971 BACKGROUND

• Chen L, Duan X, Xing F, Liu G, Gong M, Li L, Chen R, Xiang Z. Effects of pulsed electromagnetic field therapy on pain, stiffness and physical function in patients with knee osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2019 Dec 16;51(11):821-827. doi: 10.2340/16501977-2613.

  PMID: 31583420 BACKGROUND

• Kaur S, Pandhi P, Dutta P. Painful diabetic neuropathy: an update. Ann Neurosci. 2011 Oct;18(4):168-75. doi: 10.5214/ans.0972-7531.1118409.

  PMID: 25205950 BACKGROUND

• Paolucci T, Pezzi L, Centra AM, Giannandrea N, Bellomo RG, Saggini R. Electromagnetic Field Therapy: A Rehabilitative Perspective in the Management of Musculoskeletal Pain - A Systematic Review. J Pain Res. 2020 Jun 12;13:1385-1400. doi: 10.2147/JPR.S231778. eCollection 2020.

  PMID: 32606905 BACKGROUND

• Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010 Mar 19;340:c1066. doi: 10.1136/bmj.c1066. No abstract available.

  PMID: 20304934 BACKGROUND

• Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol. 2009 May;62(5):499-505. doi: 10.1016/j.jclinepi.2009.01.012.

  PMID: 19348976 BACKGROUND

• Witt CM. Efficacy, effectiveness, pragmatic trials--guidance on terminology and the advantages of pragmatic trials. Forsch Komplementmed. 2009 Oct;16(5):292-4. doi: 10.1159/000234904. Epub 2009 Aug 25. No abstract available.

  PMID: 19887807 BACKGROUND

• Yang X, He H, Ye W, Perry TA, He C. Effects of Pulsed Electromagnetic Field Therapy on Pain, Stiffness, Physical Function, and Quality of Life in Patients With Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials. Phys Ther. 2020 Jul 19;100(7):1118-1131. doi: 10.1093/ptj/pzaa054.

  PMID: 32251502 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anne Majumdar

  St Marys University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Majumdar

CONTACT

020 8240 2312; anne.majumdar@stmarys.ac.uk

Charlotte Foster-Brown

CONTACT

+447899973829; charlotte.foster-brown@stmarys.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Administrator

Model Details: Consenting participants will be randomised into either the PEMF device group or the waiting list control group. There will be 30 participants in the PEMF group and 30 in the waiting list control group.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)