Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000921280
Ethics application status
Approved
Date submitted
28/05/2018
Date registered
31/05/2018
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Pulsed Low Frequency Magnetic Field Therapy on Pain Intensity in Patients with Musculoskeletal Chronic Low Back Pain: A Randomized Double Blind Placebo Controlled Trial
Scientific title
Effects of Pulsed Low Frequency Magnetic Field Therapy on Pain Intensity in Patients with Musculoskeletal Chronic Low Back Pain: A Randomized Double Blind Placebo Controlled Trial
Secondary ID [1] 295029 0
Grant number IAU-2017-308-CAMS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 308052 0
Condition category
Condition code
Alternative and Complementary Medicine 307099 307099 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 307101 307101 0 0
Physiotherapy
Musculoskeletal 307126 307126 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two-arm randomized, double blind, placebo controlled clinical trial. The trial will be conducted at the department of physical therapy of King Fahd Hospital of the University. King Fahd Hospital of the University is an 800 beds teaching hospital located at the Eastern Province of the Kingdom of Saudi Arabia. All researchers are clinicians at the departments of physical therapy and orthopedics. All participants will be recruited from the Hospital. All screening, interventions and evaluation will be done by qualified musculoskeletal physical therapists who have 5 or more years of clinical experience.
Each participant will be assigned randomly to either the experimental group which will receive Pulsed Low Frequency Magnetic Field Therapy (PLFMF) and the conventional physical therapy program or the control group which will receive sham PLFMF and the conventional physical therapy program. Patients will be asked to lie down on the magnetic mattress for 20 minutes/session, three sessions a week for a total of 18 sessions (6 weeks). Each session (intervention or placebo) will last for 60 minutes as follows: 20 minutes for active PLFMF or placebo followed by 20 minutes for hot packs covering the lower back area and 20 minutes for exercises respectively.
In the treatment group, the BEMER mattress will be activated whereas in the control group (placebo), no magnetic field will be generated. The conventional physical therapy program consists of:
• Hot packs for 20 minutes;
• Back, hamstring and calf muscles stretching (performed from long setting position)
• Lumbar erector spinae muscles self-stretching;
• back muscles strengthening (back extension and bridging);
• Abdominal muscles strengthening (posterior pelvic tilt and sit ups);
Participants will be asked to hold the above positions for 5 seconds. Each exercise will be done 5 times per session with 1 minute rest between any two repetitions.
The BEMER 3000 (BEMER Int. AG) will be used to deliver PLFMF (the machine will be pre-programmed with an average intensity of 14 µT). The signal comprises of a series of half-wave-shaped sinusoidal intensity variations. The signal which starts with low values slowly increases and then decreases but it does not go back to the initial value (i.e. stay above zero). The intensity will gradually get denser with the repetition of the sequence leading to an increase in the ups and downs with repetition. Every second this procedure will be repeated 33.3 times with a reversal of polarity every 2 minutes.
Trial staff will monitor adherence to the either treatment sessions through session attendance.
Intervention code [1] 301362 0
Rehabilitation
Comparator / control treatment
The control group will receive sham PLFMF (the machine will not be activated, i.e. no magnetic field will be generated) and the conventional physical therapy program. Patients will be asked to lie down on the magnetic mattress for 20 minutes/session, three sessions a week for a total of 18 sessions (6 weeks). The conventional physical therapy program consists of:
• Hot packs for 20 minutes;
• Back, hamstring and calf muscles stretching (performed from long setting position)
• Lumbar erector spinae muscles self-stretching;
• back muscles strengthening (back extension and bridging);
• Abdominal muscles strengthening (posterior pelvic tilt and sit ups);
Participants will be asked to hold the above positions for 5 seconds. Each exercise will be done 5 times per session with 1 minute rest between any two repetitions.
Trial staff will monitor adherence to the either treatment sessions through session attendance.
Control group
Placebo

Outcomes
Primary outcome [1] 306058 0
The percentage change in pain intensity by calculating the percentage change in numerical rating scale (NRS) of pain.
The percentage change in pain will be calculated at each post-baseline assessment as:
100 x ((difference between baseline and post-pain NRS scores))/(baseline NRS score)
Timepoint [1] 306058 0
Each participant will get intervention for 6 weeks, 3 sessions / week. The primary time point will be 24 weeks after completing the 6-week treatment.
Secondary outcome [1] 347450 0
The percentage change in pain intensity by calculating the percentage change in numerical rating scale (NRS) of pain.
Timepoint [1] 347450 0
a. end of the 3rd and the 6th week from the beginning of intervention and
b. 6 weeks, 12 weeks and 24 weeks after the end of the intervention sessions.
Secondary outcome [2] 347501 0
Quality of life assessed using Short Form 36 (SF-36) quality of life questionnaire.
Timepoint [2] 347501 0
1) Baseline, end of the 3rd and the 6th week from the beginning of intervention and,
2) At 6 weeks, 12 weeks and 24 weeks after completing the 6-week treatment.
Secondary outcome [3] 347502 0
Disability assessed by the Roland and Morris Disability Questionnaire.
Timepoint [3] 347502 0
1) Baseline, end of the 3rd and the 6th week from the beginning of intervention and,
2) At 6 weeks, 12 weeks and 24 weeks after completing the 6-week treatment.
Secondary outcome [4] 347503 0
Function measurement assessed by Patient Specific Functional Scale.
Timepoint [4] 347503 0
1) Baseline, end of the 3rd and the 6th week from the beginning of intervention and,
2) At 6 weeks, 12 weeks and 24 weeks after completing the 6-week treatment.
Secondary outcome [5] 347504 0
Change in condition assessed by Global perceived effect of condition change.
Timepoint [5] 347504 0
1) Baseline, end of the 3rd and the 6th week from the beginning of intervention and,
2) At 6 weeks, 12 weeks and 24 weeks after completing the 6-week treatment.
Secondary outcome [6] 347505 0
Quality of sleep assessed by Pittsburgh Sleep Quality Index.
Timepoint [6] 347505 0
1) Baseline, end of the 3rd and the 6th week from the beginning of intervention and,
2) At 6 weeks, 12 weeks and 24 weeks after completing the 6-week treatment.
Secondary outcome [7] 347506 0
Fatigue assessed by Modified Fatigue impact scale.
Timepoint [7] 347506 0
1) Baseline, end of the 3rd and the 6th week from the beginning of intervention and,
2) At 6 weeks, 12 weeks and 24 weeks after completing the 6-week treatment.

Eligibility
Key inclusion criteria
• Clinical evidence of musculoskeletal chronic low back pain including subtype classification (nociceptive versus peripheral neuropathic versus central sanitization);
• Age 18-60 years old;
• Primary complaint of pain (at least a score of 5 out of 10 on a 0- 10 numerical rating scale) in the area between the 12th rib and buttock crease, with or without leg pain for 3 months or more;
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant or lactating
• Significant spinal pathology (e.g. spinal fracture, cauda equina syndrome, spinal infective or inflammatory diseases, , metastatic);
• Spinal surgery within the preceding 6 months;
• Recent organ transplants.
• Heart pace maker.
• Cardiac arrhythmia, tachycardia conditions or large aneurysm.
• Heavy psychosis.
• Epileptic episodes.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random permuted block design of size four and six
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Calculation: A total sample size of 200 (100 in each arm) will achieve 90% power to detect a mean difference of percentage reduction in Numerical rating scale (NRS) pain of 10% between the two treated arms at week-24. The mean percentage reduction in NRS pain is assumed to be 15% in the control arm (patient treated with SHAM program) and 25% in patients who receive PLFMF therapy. A 25 standard deviation is considered along with a two-sided significance level (alpha) of 5% using a two-sample equal-variance t-test. The sample size allows for 15 percent of patients lost to follow-up at week 24.
Analysis: All randomized patients will be analyzed on the intent-to-treat basis. Safety analyses will be performed for all patients who received at least one treatment session. Baseline characteristics will be presented by treatment group. Binary and categorical variables will be summarized by frequencies and percentages. Percentages will be calculated according to the number of patients for whom data are available. Where values are missing, the denominator, which will be less than the number of patients assigned to the treatment group will be reported either in the body or a footnote of the summary table. Continuous variables will be summarized by mean and standard deviation as well as by quartiles.
Treatment effect for the primary and continuous secondary outcomes will be assessed through ANCOVA adjusted for the baseline measurement score. Overall treatment effect over time on all continuous outcomes, repeatedly collected over the course of the study, will be estimated using mixed linear models to take into account the correlation within each individual. The mixed linear model will include random intercept adjusted with the baseline score, time as categorical and the interaction between treatment and time.
Categorical binary efficacy measures will be primarily analysed using logistic regression. All tests will be two-sided with P-values less than 0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2018
Actual
2/09/2018
Date of last participant enrolment
Anticipated
1/09/2019
Actual
Date of last data collection
Anticipated
28/02/2020
Actual
Sample size
Target
200
Accrual to date
78
Final
Recruitment outside Australia
Country [1] 10511 0
Saudi Arabia
State/province [1] 10511 0
Eastern Province

Funding & Sponsors
Funding source category [1] 299609 0
University
Name [1] 299609 0
Deanship of Research, Imam Abdulrahman Bin Faisal University
Country [1] 299609 0
Saudi Arabia
Primary sponsor type
University
Name
Deanship of Research, Imam Abdulrahman Bin Faisal University
Address
P.O. Box 2435 Dammam 31451, Kingdom of Saudi Arabia.
Country
Saudi Arabia
Secondary sponsor category [1] 298930 0
Hospital
Name [1] 298930 0
King Fahd Hospital of the University
Address [1] 298930 0
P.O. Box 40046, Khobar 31952, Kingdom of Saudi Arabia
Country [1] 298930 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300512 0
University of Imam Abdulrahman Bin Faisal IRB committee
Ethics committee address [1] 300512 0
Ethics committee country [1] 300512 0
Saudi Arabia
Date submitted for ethics approval [1] 300512 0
12/03/2017
Approval date [1] 300512 0
07/06/2017
Ethics approval number [1] 300512 0
Approval ID: IRB-2017-03-129.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2748 2748 0 0
/AnzctrAttachments/375210-IRB Approval.pdf (Ethics approval)
Attachments [2] 2749 2749 0 0
/AnzctrAttachments/375210-Effects of Pulsed Low Frequency Magnetic Field Therapy on Patients with Chronic low back pain May 22 2018.docx (Protocol)

Contacts
Principal investigator
Name 83898 0
Prof Fuad A. Abdulla
Address 83898 0
Department of Physical Therapy
University of Imam Abdulrahman Bin Faisal University
King Faisal Street
Dammam 31451
Country 83898 0
Saudi Arabia
Phone 83898 0
+966 13 3331308
Fax 83898 0
Email 83898 0
[email protected]
Contact person for public queries
Name 83899 0
Fuad A. Abdulla
Address 83899 0
Department of Physical Therapy
University of Imam Abdulrahman Bin Faisal University
King Faisal Street
Dammam 31451
Country 83899 0
Saudi Arabia
Phone 83899 0
+966 13 3331308
Fax 83899 0
Email 83899 0
[email protected]
Contact person for scientific queries
Name 83900 0
Fuad A. Abdulla
Address 83900 0
Department of Physical Therapy
University of Imam Abdulrahman Bin Faisal University
King Faisal Street
Dammam 31451
Country 83900 0
Saudi Arabia
Phone 83900 0
+966 13 3331308
Fax 83900 0
Email 83900 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEffects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: Study protocol for a randomised double-blind placebo-controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-024650
N.B. These documents automatically identified may not have been verified by the study sponsor.