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Trial registered on ANZCTR


Registration number
ACTRN12618001930279
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
28/11/2018
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between central and external applications of multi-session interferential therapy on pain
Scientific title
A Double-Blind Placebo-Controlled Clinical Investigation into Pain Reduction Effect of Placing the Pain Spot outside the Intersection Area of the Two Currents of Interferential Therapy Compared to Traditional Method on multi-session bases
Secondary ID [1] 296637 0
None
Universal Trial Number (UTN)
U1111-1224-1441
Trial acronym
Linked study record
ACTRN12617000505303 was conducted by the author earlier and registered. The present study is being conducted based on the recommendation of the registered study, based on the same rational and following the same methodology and protocol of recruiting subjects and data analysis. However, the present study will increase the treatment sessions from one (in the previous study) to 6 sessions.

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal pain 310466 0
Condition category
Condition code
Musculoskeletal 309178 309178 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 309256 309256 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that will be applied is named interferential therapy (IFT) which is a medium frequency current (4000-4100 Hz) electrical stimulation being used on a daily bases by physiotherapists to manage musculoskeletal pain. In the present work, IFT will be delivered by a licensed physiotherapist in a physiotherapy clinic to the painful spot of the subject's back area via 4 rubber electrodes of 8X6 cm, connected to the IFT machine, while the subject is in a comfortable prone position. The electrodes will be attached to the back of the subject around the most painful spot. In the central application, the electrodes will be attached in a way so that the currents from each pair of electrodes intersect in the painful spot while in the external application they will be attached so that the painful spot will be placed between two different electrodes at 2 cm outside the borderers of the electrodes.IFT will be delivered for 6 consecutive sessions, with washout time of 48 hours, for 20 minutes each at a medium frequency current of 4000-4100 Hz producing an amplitude modulated frequency (AMF)100Hz delivered on sweep pattern of 6 seconds between upper and lower boundaries of the AMF and a comfortable intensity as its usually applied in clinics. The author will make sure that the same protocol of application of IFT is followed at each session. IFT pain reduction effect will be measured using primary and secondary outcome measures mentioned in step 4.
Intervention code [1] 312947 0
Treatment: Devices
Comparator / control treatment
The subject of the control group will be provided with sham interferential therapy (IFT) where the same application of the IFT will be done except for operating the IFT machine. That is the control group will go through the same procedure of the treatment group including attaching the IFT electrodes to their back but the IFT machine will not be put on. However, to find out if the whole story of IFT effect is coming from subjects feeling of being taken care of and the influence of treating environment (placebo) but no real effect of the electrical stimulation the IFT, subjects will be told that the IFT machine is producing a subthreshold sensation that they may or may not feel.
Control group
Placebo

Outcomes
Primary outcome [1] 308149 0
Numerical pain scale, 0-10 where 0 represents the minimum pain ever and 10 represent the worst pain possible

Timepoint [1] 308149 0
measurements will be taken at baseline and after 20 minutes of IFT.
Primary outcome [2] 308234 0
Pressure pain threshold will be measured by algometer FDX 50. the tip of the algometer will be pressed against the painful spot until the feeling turns into strong pain.
Timepoint [2] 308234 0
Will be measured at baseline and after 20 minutes of IFT at each session.
Primary outcome [3] 308235 0
Pain distribution (from its source to as far as it goes) will be measured by a tape measure.
Timepoint [3] 308235 0
Will be measured at baseline and after 20 minutes of IFT at each session.
Secondary outcome [1] 354085 0
The range of motion of the back forward bending (Back forward flexion) will be assessed by measuring the distance from the tip of the right middle finger to the floor using a tape measure.
Timepoint [1] 354085 0
Will be measured at baseline and after 20 minutes of IFT at each session.

Eligibility
Key inclusion criteria
male and female volunteer subjects (age 20-70 years and BMI 18.5-24.9 kg/m2) complain of low back pain and haven’t been treated with interferential therapy before or at least in the last 12 months.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They should have no neurological impairment, no breaks or irritation of the skin of the low back area. They must be free from heart disease, renal disease, systemic disorder and intellectual disability.

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)
After confirming the subject eligibility to be included in the study based on inclusion criteria, he will be asked to withdraw a piece of identical papers from an opaque envelope. Each piece of paper has a unique number 1-160, where 1 refers to group 1; 2 refers to group 2; 3 refers to group 3; 4 refers to group 4; 5 refers to group 1; 6 refers to group 2 and so on. Before assigning the subject to the group and starting the treatment session, the assessor who has no knowledge as to which group the subject was assigned, will assess subjects pain and range of motion and leave the treatment cubicle. Then, the therapist will come into the cubicle and position the subject, applies the electrodes and operates the machine according to the assigned group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was will be achieved using 162 numbers on identical pieces of paper placed in a dark envelope. Each number refers to one of the tested groups. On an external index sheet these numbers are matched to their corresponding groups i.e., 1 refers to group 1; 2 refers to group 2; 3 refers to group 3; 4 refers to group 4; 5 refers to group 1; 6 refers to group 2 and so on. Subject will be asked to remove one piece of paper from the envelope and give it to the therapist who assigned the subject to the group corresponding to the number (1 = tradition IFT application, 2 = external IFT application, 3 = placebo traditional IFT application, and 4 = placebo external IFT application).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous work using same intervention, 40 subjects in each group are estimated to be adequate for detecting a difference of at least 20% in maximum pain scores on the VAS between groups using a repeated measure design at a significance level of 0.05 and confidence level of 1-ß = 80%.

Data will be analyzed using SPSS. Results will be cross-tabulated to examine the independency between variables. Where two or more continuous independent variables will be examined, t-test and analysis of variance will be used as adequate. An ANOVA with repeated measures will be used to compare the means of the four groups where the multiple measures for the same participants will be made per each group. Frequency tables' bar and lines graphs will be performed as descriptive statistics. A P-value of less than 0.05 will be considered significant in all statistical analysis.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2018
Actual
Date of last participant enrolment
Anticipated
2/07/2019
Actual
Date of last data collection
Anticipated
20/07/2019
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 21050 0
Saudi Arabia
State/province [1] 21050 0
Western Province, Taif

Funding & Sponsors
Funding source category [1] 301215 0
Self funded/Unfunded
Name [1] 301215 0
Dr Abulkhair Beatti
Country [1] 301215 0
Saudi Arabia
Primary sponsor type
Individual
Name
Dr Abulkhair Beatti
Address
Armed Forces Centre for Health Rehabilitation
King Abdullah Road
Massarah 26526
Taif, Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 300848 0
None
Name [1] 300848 0
Address [1] 300848 0
Country [1] 300848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301960 0
The research ethics committee of Armed Forces Hospitals, Taif, western Region, Saudi Arabia
Ethics committee address [1] 301960 0
Ethics committee country [1] 301960 0
Saudi Arabia
Date submitted for ethics approval [1] 301960 0
11/11/2018
Approval date [1] 301960 0
19/11/2018
Ethics approval number [1] 301960 0
REC.T. 2018-11-357

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

Contacts
Principal investigator
Name 88678 0
Dr Abulkhair Beatti
Address 88678 0
Armed Forces Centre for Health Rehabilitation,
King Abdullah Road
Massarah, Taif 26526
Saudi Arabia
Country 88678 0
Saudi Arabia
Phone 88678 0
+966506366748
Fax 88678 0
Email 88678 0
a.beatti@gmail.com
Contact person for public queries
Name 88679 0
Abulkhair Beatti
Address 88679 0
Armed Forces Centre for Health Rehabilitation,
King Abdullah Road
Massarah, Taif 26526
Saudi Arabia
Country 88679 0
Saudi Arabia
Phone 88679 0
+966506366748
Fax 88679 0
Email 88679 0
a.beatti@gmail.com
Contact person for scientific queries
Name 88680 0
Abulkhair Beatti
Address 88680 0
Armed Forces Centre for Health Rehabilitation,
King Abdullah Road
Massarah, Taif 26526
Saudi Arabia
Country 88680 0
Saudi Arabia
Phone 88680 0
+966506366748
Fax 88680 0
Email 88680 0
a.beatti@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.