ANZCTR - Registration

Please note that the ANZCTR will be unattended on Monday 9th June due to an Australian public holiday.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12625000552482

Ethics application status

Approved

Date submitted

13/05/2025

Date registered

30/05/2025

Date last updated

30/05/2025

Date data sharing statement initially provided

30/05/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Transcutaneaous Electrical Nerve Stimulation (TENS) vs TENS with music in persistent spinal pain management : A pilot feasibility trial

Scientific title

Transcutaneaous Electrical Nerve Stimulation (TENS) vs TENS with music in persistent spinal pain management : A pilot feasibility trial..

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Spinal pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This will be a prospective, randomised controlled pilot study to compare Transcutaneous Electric Nerve stimulation(TENS) alone (control and standard treatment) versus TENS combined with patient self-selected music (intervention). The TENS unit consists of a hand-held device connected to electrodes which are attached to the skin. The device when switched on delivers low-voltage impulses to the electrodes the frequency and intensity of which can be controlled by the participant. Participants are free to select from available mode of delivery of the impulses which include Burst, Continuous or Modulate. The impulses will be felt as a tingling. The electrodes are usually placed on the back near the area that is painful.

The patients will be randomised to receive 2 weeks of TENS therapy and 2 weeks of TENS with music. The order in which this is delivered will be determined by randomisation. Thus one group will receive standard TENS for 2 weeks followed by TENS with music for 2 weeks. This order will be reversed in the other group. The participants will be compared against themselves for the outcomes thus reducing the number of participants to power the study. There is no washout period.

The TENS will be self administered. Administration of TENS will be for the duration of 1 hour at a time, up to a maximum of 6 times during each 24 hours, for 2 weeks and with music from a self selected play list from a set of genres Classical, Easy listening, Pop, Rhythm & Blues, Vocal and Musical. We will use a participant diary to record the duration of TENS each day and the type of music listened to.

The pulse intensity that can be set in the TENS machine can vary from 0-80milliAmpere, pulse frequency between 2Hz-150Hz .

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Transcutaneous Electric Nerve stimulation(TENS) alone will be the control/comparator. Administration of TENS will be for the duration of 1 hour at a time, up to a maximum of 6 times during each 24 hours. Participants are free to select from available modes, which include Burst, Continuous or Modulate. Pulse width, pulse rate and intensity can also be modified by the participant. We will use participant diary to monitor adherence

Control group

Active

Outcomes

Primary outcome [1]

Feasibility of the intervention

Timepoint [1]

Baseline, 2 weeks and 4 weeks post intervention commencement

Primary outcome [2]

Drop out rate

Timepoint [2]

2 and 4 weeks post commencement

Primary outcome [3]

Percentage of eligible participants that consented

Timepoint [3]

Base line

Secondary outcome [1]

Pain Intensity

Timepoint [1]

Baseline and daily for 4 weeks

Secondary outcome [2]

Analgesic consumption including Oral Morphine Equivalent Doses as a composite outcome

Timepoint [2]

baseline and daily for 4 weeks

Secondary outcome [3]

Patient satisfaction with intervention

Timepoint [3]

Baseline, 2 weeks and 4 weeks post intervention commencement

Secondary outcome [4]

Mood

Timepoint [4]

Baseline, 2 weeks and 4 weeks post intervention commencement

Secondary outcome [5]

Function

Timepoint [5]

Baseline, 2 weeks, 4 weeks post intervention commencement

Secondary outcome [6]

Compliance with other treatment recommendations

Timepoint [6]

Baseline, 2 weeks and 4 weeks post intervention commencement

Secondary outcome [7]

Adverse reactions as a composite and this may include worsening pain, skin reaction to the electrode and other reactions

Timepoint [7]

Daily for 4 weeks

Eligibility

Key inclusion criteria

All patients 18 years and over presenting with spinal pain with or without radicular limb pain attending pain clinic at Westmead Hospital will be eligible

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Those who have used TENS or Music therapy in the past to manage their pain, those with a significant hearing impairment, lack of technical ability to play music through Spotify, or an inability to communicate in English

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised sequence generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

2/06/2025

Actual

Date of last participant enrolment

Anticipated

1/06/2026

Actual

Date of last data collection

Anticipated

30/06/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Westmead Hospital

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Westmead Hospital, Department of Anaesthesia

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/11/2024

Approval date [1]

05/02/2025

Ethics approval number [1]

Summary

Brief summary

The primary aim of this study is to test the feasibility of a clinical trial comparing TENS alone to TENS combined with self-selected music, in patients with persistent spinal pain. The results of this feasibility study will be used to inform a larger trial of these interventions in patients with persistent spinal pain. A secondary aim is to study the analgesic effects of each intervention over the course of the TENS treatment, impact of participant's function and mood  and adverse outcomes.We hypothesise that administration of TENS combined with music will be equally feasible compared to TENS alone, and will be well tolerated by participants. Secondly, we hypothesise that participants will have superior analgesia when TENS is combined with music treatment will have improved analgesia compared to TENS alone.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Seema Radhakrishnan

Address

Westmead Pain Management Centre,Westmead Hospital, Cnr Hawkesbury and Darcy roads, Westmead, NSW, 2145

Country

Australia

Phone

+610288904597

Fax

[email protected]

Contact person for public queries

Name

Seema Radhakrishnan

Address

Westmead Pain Management Centre,Westmead Hospital, Cnr Hawkesbury and Darcy roads, Westmead, NSW, 2145

Country

Australia

Phone

+610288904597

Fax

[email protected]

Contact person for scientific queries

Name

Seema Radhakrishnan

Address

Westmead Pain Management Centre,Westmead Hospital, Cnr Hawkesbury and Darcy roads, Westmead, NSW, 2145

Country

Australia

Phone

+610288904597

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
A finite period of: 5 years

Where can requests to access individual participant data be made, or data be obtained directly?

• Postal address: Westmead Pain Management Centre, PO Box 533, Wentworthville, NSW 2145

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically