Trial Review

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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] 311210 0
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) 332398 0
Chronic Nonspecific Low Back Pain (onset more than 12 weeks) 332399 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329098 329098 0 0
Physiotherapy
Musculoskeletal 330166 330166 0 0
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] 327662 0
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] 336923 0
Pain
Timepoint [1] 336923 0
Before treatment and Immediately after treatment
Primary outcome [2] 336924 0
Lumbar Flexion
Timepoint [2] 336924 0
Before and Immediately after treatment
Primary outcome [3] 337926 0
Lumbar extension
Timepoint [3] 337926 0
Before treatment and after treatment
Secondary outcome [1] 430175 0
Lumbar lateral Flexion
Timepoint [1] 430175 0
Before treatment and after treatment
Secondary outcome [2] 433745 0
Lumbar rotation
Timepoint [2] 433745 0
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?
No
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
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26044 0
Indonesia
State/province [1] 26044 0
Yogyakarta

Funding & Sponsors
Funding source category [1] 315469 0
University
Name [1] 315469 0
Universitas Negeri Yogyakarta
Country [1] 315469 0
Indonesia
Primary sponsor type
University
Name
Universitas Negeri Yogyakarta
Address
Jalan Kolombo No 1 Karangmalang Yogyakarta
Country
Indonesia
Secondary sponsor category [1] 317539 0
None
Name [1] 317539 0
Address [1] 317539 0
Country [1] 317539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314412 0
The ethics committee at Directorate of Research and Community Service Universitas Negeri Yogyakarta
Ethics committee address [1] 314412 0
Ethics committee country [1] 314412 0
Indonesia
Date submitted for ethics approval [1] 314412 0
12/06/2023
Approval date [1] 314412 0
06/07/2023
Ethics approval number [1] 314412 0
No. T/17/UN34.9/KP.06.07/2023

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

Contacts
Principal investigator
Name 131366 0
Prof Novita Intan Arovah
Address 131366 0
Faculty of Sports Science, Universitas Negeri Yogyakarta, Jalan Kolombo No 1 Yogyakarta Indonesia 55281
Country 131366 0
Indonesia
Phone 131366 0
+6285643350402
Fax 131366 0
Email 131366 0
[email protected]
Contact person for public queries
Name 131367 0
Novita Intan Arovah
Address 131367 0
Faculty of Sports Science, Universitas Negeri Yogyakarta, Jalan Kolombo No 1 Yogyakarta Indonesia 55281
Country 131367 0
Indonesia
Phone 131367 0
+6285643350402
Fax 131367 0
Email 131367 0
[email protected]
Contact person for scientific queries
Name 131368 0
Novita Intan Arovah
Address 131368 0
Jalan Kolombo No 1 Yogyakarta Indonesia 55281
Country 131368 0
Indonesia
Phone 131368 0
+6285643350402
Fax 131368 0
Email 131368 0
[email protected]

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: [email protected] )


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21313Ethical 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.