Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00641

2 Trial Registration Date

2018-12-07

i Registration Status

Prospective

3 Secondary IDs

CREC.2018.480

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, CUHK

5 Primary Sponsor

Department of Anaesthesia & Intensive Care, CUHK

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Winnie Samy

ii Address

Rm 04A49, 4th floor Main Clinical Block & Trauma Centre
Prince of Wales Hopsital
Ngan Shing Street
Shatin
NT

iii Phone

35052734

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care

vi Country

Hong Kong SAR, China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Cheuk Yin Li

ii Address

Rm 04A49, 4th floor Main Clinical Block & Trauma Centre
Prince of Wales Hopsital
Ngan Shing Street
Shatin
NT

iii Phone

35052734

iv Email

arahaha@cuhk.edu.hk

v Affiliation

Anaesthesia & Intensive Care, The Chinese University of Hong Kong

vi Country

Hong Kong, SAR, China

9 Official Scientific Title of the Study

The use of electromagnetic transduction therapy in patients with chronic myofascial pain attending an outpatient pain management clinic: a pilot feasibility randomized controlled trial

10 Public Title

The use of electromagnetic transduction therapy in patients with chronic myofascial pain attending an outpatient pain management clinic: a pilot feasibility randomized controlled trial

i Public Title in Chinese 研究名稱

體外電磁波傳遞療法在治療長期肌筋膜疼痛成效之先導隨機性研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-11-26

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC.2018.480

14 Medical Condition Being Studied

Chronic myofascial pain

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Electromagnetic transduction therapy (EMTT) is a new modality of non-invasive peripheral magnetic stimulation therapy. It generates pulsed electromagnetic field that activates the body’s healing mechanisms and enhances tissue repair. EMTT is delivered by the Cellactor MT1 device (Storz Medical AG, Tägerwilen, Switzerland). It generates the electromagnetic field of therapeutic range at a loop-liked hand-held device (the treatment loop). During the therapy, the treatment loop is placed over patient’s painful area. Patients do not need to undress while receiving the therapy. There will be repetitive ‘tick’ sound when the EMTT machine is operating. As there is no direct skin contact or no temperature change, patients might not be able to perceive the therapy except hearing the ‘tick’ sound.

iii Dosage form of the intervention

not a pharmaceutical study; 80mT with an impulse frequency of 3Hz & electric power of 30kV

iv Dosage of the intervention

not a pharmaceutical study; 80mT with an impulse frequency of 3Hz & electric power of 30kV

v Duration of the intervention

20 minutes

vi Frequency of the intervention

8 sessions over 4 weeks

16 Comparative Treatments

i Description/ name of comparative treatments

Control group will have EMTT treatment without the machine being turned on. During the therapy, the treatment loop is placed over patient’s painful area. Patients do not need to undress while receiving the therapy. Since the machine will not be turned on, so there will be no ‘tick’ sound during the treatment session.
Both intervention group and control group will continue their conventional treatment during the study period

ii Dosage form of the comparative treatments

not applicable

iii Dosage of the comparative treatments

not applicable

iv Duration of the comparative treatments

20 minutes

v Frequency of the comparative treatments

8 sessions over 4 weeks

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

18-85-year-old patients who have moderate to severe myofascial pain lasting for more than 3 months and are able to complete questionnaires will be invited into this study. Pain severity with reported NRS >= 5 on a scale out of 10 will be defined as moderate to severe. Patients with more than 1 myosfacial pain region will receive therapy to the most distressing region.

ii Exclusion Criteria

pregnant, illiterate, with pain severity NRS <5, suffering from fibromyalgia or widespread pain (>= 4 painful areas), having on-going litigation or compensation issue and significant psychiatric disorders with psychotic features or history of suicidal attempt. Patients who have contraindications to EMTT therapy will be excluded as well

iii Age Minimum

18

iv Age Maximum

85

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

prospective

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2020-02-03

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Pain intensity

ii The metric or method of measurement used

numerical rating scale (NRS) 0-10

iii The timepoint(s) of primary interest

baseline, after each session, 1 month, & 6 month after completion of EMTT

24 Secondary Outcome

i The Name of the outcome

Non symptomatic aspects of pain i.e. Physical functioning, mood and global improvement, determination of their clinically importance, & any adverse reactionof

ii The metric or method of measurement used

Brief Pain Inventory (BPI) Interference Scale, Beck Depression Inventory (BDI), Patient Global Impression of Change (PGIC)

iii The timepoint(s) of primary interest

Baseline, after each EMTT session, 1 month & 6 month after EMTT

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-01-26

27 Primary Registry and Trial Identifying Number

ChiCTR1900021031

28 Date of Registration in Primary Registry

2018-12-07

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Trial History Detail on 2020-01-30