Trial Review

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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] 314338 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal pain 337308 0
Condition category
Condition code
Musculoskeletal 333696 333696 0 0
Other muscular and skeletal disorders
Anaesthesiology 333931 333931 0 0
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] 330949 0
Treatment: Other
Intervention code [2] 331138 0
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] 341293 0
Feasibility of the intervention
Timepoint [1] 341293 0
Baseline, 2 weeks and 4 weeks post intervention commencement
Primary outcome [2] 341576 0
Drop out rate
Timepoint [2] 341576 0
2 and 4 weeks post commencement
Primary outcome [3] 341577 0
Percentage of eligible participants that consented
Timepoint [3] 341577 0
Base line
Secondary outcome [1] 447032 0
Patient satisfaction with intervention
Timepoint [1] 447032 0
Baseline, 2 weeks and 4 weeks post intervention commencement
Secondary outcome [2] 447031 0
Analgesic consumption including Oral Morphine Equivalent Doses as a composite outcome
Timepoint [2] 447031 0
baseline and daily for 4 weeks
Secondary outcome [3] 447035 0
Compliance with other treatment recommendations
Timepoint [3] 447035 0
Baseline, 2 weeks and 4 weeks post intervention commencement
Secondary outcome [4] 447030 0
Pain Intensity
Timepoint [4] 447030 0
Baseline and daily for 4 weeks
Secondary outcome [5] 447036 0
Adverse reactions as a composite and this may include worsening pain, skin reaction to the electrode and other reactions
Timepoint [5] 447036 0
Daily for 4 weeks
Secondary outcome [6] 447033 0
Mood
Timepoint [6] 447033 0
Baseline, 2 weeks and 4 weeks post intervention commencement
Secondary outcome [7] 447034 0
Function
Timepoint [7] 447034 0
Baseline, 2 weeks, 4 weeks post intervention commencement

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?
No
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
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27866 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 44061 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 318857 0
Hospital
Name [1] 318857 0
Westmead Hospital
Country [1] 318857 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital, Department of Anaesthesia
Address
Country
Australia
Secondary sponsor category [1] 321315 0
None
Name [1] 321315 0
Address [1] 321315 0
Country [1] 321315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317473 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317473 0
Ethics committee country [1] 317473 0
Australia
Date submitted for ethics approval [1] 317473 0
12/11/2024
Approval date [1] 317473 0
05/02/2025
Ethics approval number [1] 317473 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141158 0
Dr Seema Radhakrishnan
Address 141158 0
Westmead Pain Management Centre,Westmead Hospital, Cnr Hawkesbury and Darcy roads, Westmead, NSW, 2145
Country 141158 0
Australia
Phone 141158 0
+610288904597
Fax 141158 0
Email 141158 0
[email protected]
Contact person for public queries
Name 141159 0
Seema Radhakrishnan
Address 141159 0
Westmead Pain Management Centre,Westmead Hospital, Cnr Hawkesbury and Darcy roads, Westmead, NSW, 2145
Country 141159 0
Australia
Phone 141159 0
+610288904597
Fax 141159 0
Email 141159 0
[email protected]
Contact person for scientific queries
Name 141160 0
Seema Radhakrishnan
Address 141160 0
Westmead Pain Management Centre,Westmead Hospital, Cnr Hawkesbury and Darcy roads, Westmead, NSW, 2145
Country 141160 0
Australia
Phone 141160 0
+610288904597
Fax 141160 0
Email 141160 0
[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?
No


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.