ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000513516

Ethics application status

Approved

Date submitted

2/01/2024

Date registered

25/04/2024

Date last updated

25/04/2024

Date data sharing statement initially provided

25/04/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparing Physiotherapy Modalities in Adults with Lower Back Pain

Scientific title

Exploring the Immediate Effect of Physiotherapy Modalities on Pain and Range of Motion in Adults with Non-Specific Low Back Pain

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Subacute Nonspecific Low Back Pain (onset 4-12 weeks)

Chronic Nonspecific Low Back Pain (onset more than 12 weeks)

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A registered physiotherapist will conduct all interventions, which each will be completed once.

In the Extracorporeal Shockwave Therapy (ESWT) protocol, patients will assume a comfortable prone posture as a specialised gel is applied to the targeted area. Administered using the Swiss DolorClast device with an EvoBlue handpiece, the treatment involves 2000 shockwaves at a frequency of 15 radial shockwaves per second, with the parameters of air pressure and energy flux density administered up to 0.3 mJ/mm^2. Two distinct applicators, with varying nanometer specifications, deliver shockwaves to the paravertebral muscles and sacroiliac joints. Air pressure and energy flux density gradually increase over the initial 200 shockwaves, continuing until the patient reaches the maximum tolerable discomfort. An additional 800 shockwaves are then administered at the established settings. This protocol remains consistent for both subacute and chronic phases of non-specific low back pain (NSLBP).

In the Ultrasound Therapy (UST) protocol, patients in a prone position will undergo treatment with ultrasonic waves initiated at 1 MHz. Ultrasonic gel facilitates the transmission of waves, with intensity ranging from 1 W/cm² to 2.5 W/cm² and an effective radiating area (ERA) measuring 4-5 cm2. Parameters will be adjusted based on patient tolerance, employing continuous mode for the chronic phase and pulsatile mode for the subacute phase. The ultrasonic applicator will be manoeuvred over the treatment area using various motions for 10–15 minutes, during which patients will provide feedback on comfort and perceived effectiveness.

Meanwhile, the Shortwave Diathermy (SWD) protocol will begin with patients assuming a prone position. The therapy is administered in capacitive mode at a frequency of 27.12 MHz and a wavelength of 11.06 m. A continuous mode will be applied for the chronic phase, while the subacute phase involves a pulsed mode. The treatment duration will be set at 15 minutes.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

This study will be a one-group pre- and post-test design, which will be conducted once; therefore, there will be no control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Pain

Timepoint [1]

Before treatment and Immediately after treatment

Primary outcome [2]

Lumbar Flexion

Timepoint [2]

Before and Immediately after treatment

Primary outcome [3]

Lumbar extension

Timepoint [3]

Before treatment and after treatment

Secondary outcome [1]

Lumbar lateral Flexion

Timepoint [1]

Before treatment and after treatment

Secondary outcome [2]

Lumbar rotation

Timepoint [2]

Before and after treatment

Eligibility

Key inclusion criteria

Inclusion criteria will be a confirmed NSLBP diagnosis, a minimum age of 18, and a minimum symptom duration of four weeks

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria will encompass specific underlying causes of back pain (i.e., malignancy, neurological deficit, fracture, infection), pregnancy, and history of allergies to proposed interventions.

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)

The allocation will be centralised and concealed; The randomization will use a random generator application; thus, before the randomization process, neither the participants nor the investigators know which group an individual will be assigned to.

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

Participants will be randomly assigned to three groups in a 1:1:1 ratio. The randomization procedure will include creating a list of participants, and the allocation sequence will be established through a mobile application that utilizes a random number generator designed for Android devices by the research assistants.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size calculation :
The study's sample size will be determined using G*Power software, employing a repeated measures ANOVA within-between interaction with a preset apriori effect size of 0.3. The parameters considered included an error probability of 0.05, a power of 0.8, a correlation of 0.5 among repeated measures, and a nonsphericity correction factor of 1. This calculation results in a minimum sample size of 42 or 7 participants per group. Subsequently, participants will be randomly assigned to a 2x3 factorial design based on phases of non-specific low back pain (NSLBP) and treatment groups (subacute ESWT, subacute UST, subacute SWD, chronic ESWT, chronic UST and Chronic SWD)

Statistical analysis
Descriptive statistics, including mean and standard deviation, will be calculated for between-group comparisons. Subsequently, a longitudinal data analysis will be conducted using a mixed design Repeated Measures Analysis of Variance (split-plot RM ANOVA) test to assess two key factors: the phase effects and treatment effects on both pain levels and range of motion, pre and post-treatment (time effects). This analytical approach will allow for the examination of within-subject changes over time, making it particularly suitable for studies involving repeated measurements on the same individuals. In addition to evaluating statistical significance, clinical significance will also taken into account. This will be determined using Hedge's Correction for Cohen's D. This measure helps gauge the practical or meaningful impact of the observed effects to provide insight into the real-world relevance of the findings in the context of managing NSLBP. The statistical analysis will be carried out using SPSS 29, with a confidence level of 5%.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/05/2024

Actual

Date of last participant enrolment

Anticipated

15/05/2024

Actual

Date of last data collection

Anticipated

25/05/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Indonesia

State/province [1]

Yogyakarta

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universitas Negeri Yogyakarta

Address [1]

Jalan Kolombo No 1 Karangmalang Yogyakarta Indonesia 55281

Country [1]

Indonesia

Primary sponsor type

University

Name

Universitas Negeri Yogyakarta

Address

Jalan Kolombo No 1 Karangmalang Yogyakarta

Country

Indonesia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The ethics committee at Directorate of Research and Community Service Universitas Negeri Yogyakarta

Ethics committee address [1]

Jalan Colombo No 1 Sleman Daerah Istimewa Yogyakarta , Indonesia, 55281

Ethics committee country [1]

Indonesia

Date submitted for ethics approval [1]

12/06/2023

Approval date [1]

06/07/2023

Ethics approval number [1]

No. T/17/UN34.9/KP.06.07/2023

Summary

Brief summary


The study will investigate the effect of three types of physical therapy—shockwave, ultrasound, and heat therapy—on lower back pain without specific causes. It will involve 45 individuals,, with either new or long-term back pain. Their pain and how easily they can move will be measured before and after they receive their treatments. The aim is to examine which therapy is best at improving pain and mobility. The hypothesis is that one or more of these therapies will be effective in managing lower back pain.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Novita Intan Arovah

Address

Faculty of Sports Science, Universitas Negeri Yogyakarta, Jalan Kolombo No 1 Yogyakarta Indonesia 55281

Country

Indonesia

Phone

+6285643350402

Fax

novita@uny.ac.id

Contact person for public queries

Name

Novita Intan Arovah

Address

Faculty of Sports Science, Universitas Negeri Yogyakarta, Jalan Kolombo No 1 Yogyakarta Indonesia 55281

Country

Indonesia

Phone

+6285643350402

Fax

novita@uny.ac.id

Contact person for scientific queries

Name

Novita Intan Arovah

Address

Jalan Kolombo No 1 Yogyakarta Indonesia 55281

Country

Indonesia

Phone

+6285643350402

Fax

novita@uny.ac.id

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

The confidential individual participant data (IPD) will be shared upon request to the researcher

When will data be available (start and end dates)?

The data will be available starting with the data collection and access will be indefinite

Available to whom?

The data will be shared with other researchers when they request the data for meta-analysis

Available for what types of analyses?

The data related to the clinical trial ( the comparison of pre and pot test data between protocol)

How or where can data be obtained?

The data can be obtained from the principle researcher (email: novita@uny.ac.id )

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21313	Ethical approval					387077-(Uploaded-29-12-2023-12-43-57)-Study-related document.pdf

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.

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