Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000921684
Ethics application status
Approved
Date submitted
20/02/2023
Date registered
28/08/2023
Date last updated
28/10/2024
Date data sharing statement initially provided
28/08/2023
Date results provided
28/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of physical therapist applied treatment (massage, ultrasound, transcutaneous electrical nerve stimulation, low-level laser and exercise program) on pain, disability, psychological and health status of patients with chronic low back pain: A prospective study.
Scientific title
Efficacy of physical therapist applied treatment (massage, ultrasound, transcutaneous electrical nerve stimulation, low-level laser and exercise program) on pain, disability, psychological and health status of patients with chronic low back pain: A prospective study.
Secondary ID [1] 307723 0
None
Universal Trial Number (UTN)
U1111-1288-6732
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 329080 0
Depression 329081 0
Somatic symptom disorders 329082 0
Disability 329083 0
Pain 329084 0
Chronic low back pain 329086 0
Condition category
Condition code
Mental Health 326060 326060 0 0
Anxiety
Mental Health 326622 326622 0 0
Depression
Mental Health 326623 326623 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 326624 326624 0 0
Physiotherapy
Neurological 326625 326625 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The conventional intervention was administered to lumbosacral part by a physical therapist (one-on-one), including massage, ultrasound, TENS, low-level laser and exercise program (a sum of 10 sessions with all components of the intervention, 5 consecutive weekdays using a session attendance log). Massage (with deep stroking, wringing, friction, pulling and rolling techniques) and continuous ultrasound (frequency : 1 MHz, intensity : 1.5 W/cm2) lasted for 15 minutes and 5 minutes, respectively. Additionally, TENS was applied to lumbosacral part with four cutaneous electrodes for 20 minutes. Exercise program consisted of a strengthening part of the back and frontal abdominal muscles performed for 20 minutes with a set of 10 repetitions on each exercise (pelvic tilt, abdominal hollowing, knee to chest, oblique crunch, supine plank, bird and dog, cat and camel, lower abdominal and back extension exercises), as well as a stretching part of the hip flexors, hamstrings and lumbar extensors performed for 30 seconds on each muscle group. Last but not least, continuous low-level laser was applied with a contact method at four points over both sides of the spinal column for 80 seconds (830 nm, 120 m, 0-50000 Hz). During the treatment, patients could select to sit in a chair or lie down on a bed in the prone position in order to control for positional intolerance.
Intervention code [1] 325483 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333935 0
Somatic symptom disorders (mean and median) assesd using Somatic Symptom Scale-8 (SSS-8)
Timepoint [1] 333935 0
Timepoint: Baseline , 2 weeks (primary endpoint) and 26 weeks after the intervention commencement.
Primary outcome [2] 334481 0
Anxiety (mean and median) assesed using Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 334481 0
Timepoint: Baseline, 2 weeks primary endpoint) and 26 weeks after the intervention commencement.
Primary outcome [3] 334482 0
Depression (mean and median) assesed using Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 334482 0
Timepoint: Baseline, 2 weeks (primary endpoint) and 26 weeks after the intervention commencement.
Secondary outcome [1] 418776 0
Pain (mean and median) assesed using Pain Numerical Rating Scale (PNRS)
Timepoint [1] 418776 0
Timepoint: Baseline, 2 weeks and 26 weeks after the intervention commencement.
Secondary outcome [2] 420832 0
Disability (mean and median) assesed using Rolland-Morris Disability Questionnaire (RMDQ)
Timepoint [2] 420832 0
Timepoint: Baseline, 2 weeks and 26 weeks after the intervention commencement.
Secondary outcome [3] 420834 0
Health-related quality of life (mean and median) assesed using EuroQol-5D 5 level edition (EQ-5D-5L)
Timepoint [3] 420834 0
Timepoint: Baseline, 2 weeks and 26 weeks after the intervention commencement.

Eligibility
Key inclusion criteria
Patients with Chronic Low Back Pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with previous spinal surgery or cancer, fibromyalgia syndrome, psoriatic arthritis, rheumatoid arthritis, spinal fracture, cauda equina syndrome, spondylolisthesis, scoliosis less than or equal to 20* and ankylosing spondylitis (red flags).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative variables were summarized in mean (Standard Deviation) and in median (interquartile range), while Qualitative variables were summarized in absolute and relative frequencies. Mann-Whitney test was used for the comparison of continuous variables be-tween two groups and Kruskall-Wallis test for the comparison of continuous var-iables among more than two groups. Spearman correlations coefficients were used to explore the association of two continuous variables. Spearman’s correla-tion coefficient values (rs) greater than 0.7, of 0.69–0.4, and of less than 0.39-0.1 were considered strong, moderate and weak correlations, respectively.Multiple linear regression analyses were conducted with dependent the health status, disa-bility and pain scales in a stepwise method (p for entry 0.05, p for removal 0.10). The factors that were included as independent variables in the model were socio-demographic (age, sex, marital and employment status, educational level), life-style (Body Mass Index, physical exercise), SSD, depression and anxiety as measured by the SSS-8 and HADS questionnaires, respectively. Adjusted regres-sion coefficients (ß) with standard errors (SE) were computed from the results of the linear regression analyses. Multiple linear regression analyses were conduct-ed after having the dependent variables logarithmically transformed. All report-ed p values are two-tailed. Wilcoxon signed tests were used for pre-post intervention comparisons of all under study-scales. Repeated measurements analysis of variance (ANOVA) was used to assess the variations watched closely in all under-study scales and their association with gender and BMI over the follow up period. Bonferroni correction was adopted in case of multiple testing in order to control for type I error. Repeated measurements analysis was conducted after logarithmic transformations of the scales. Cohen’s d was adopted in order to assess the clinical significance of the intervention effects, whose values of 0. 20, 0. 50 and 0. 80 are suggestive of small, medium and large effect sizes, accordingly. Quantitative variables were expressed as mean values (SD), while qualitative varia-bles were expressed as absolute and relative frequencies. Friedman’s test was used for score comparisons between pre-, post-treatment and 6 months measurements. Bonfer-roni correction was used in order to control for type I error. The effect size estimate Kendall's W value for Friedman test was computed via the formula W = ?2/N(K-1); where ?2 is the Friedman test statistic value; N is the sample size and K the number of measurements. [40] Kendalls uses the Cohen’s interpretation guidelines of 0.1 - 0.29 (small effect), 0.3 - 0.49 (moderate effect) and >= 0.5 (large effect). [41] Multiple linear regression analysis was used with dependent the scores at 6 months. The regression equation included terms for demographics and pre-treatment scores. Adjusted regres-sion coefficients (ß) with standard errors (SE) were computed from the results of the linear regression analyses. Logarithmic transformations of the dependent variables were used due to lack of normal distribution. All reported p values are two - tailed. Statistical analyses were completed using SPSS statistical software (version 22.0) and minimum level of significance was set at p < 0.05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
30/12/2023
Date of last data collection
Anticipated
Actual
30/06/2024
Sample size
Target
154
Accrual to date
Final
159
Recruitment outside Australia
Country [1] 25276 0
Greece
State/province [1] 25276 0
Attiki

Funding & Sponsors
Funding source category [1] 311996 0
Self funded/Unfunded
Name [1] 311996 0
Country [1] 311996 0
Primary sponsor type
University
Name
School of Medicine, National and Kapodistrian University of Athens
Address
Address: 75, Mikras Asias str.,

Goudi, 11527 Athens, Greece
Country
Greece
Secondary sponsor category [1] 313490 0
Hospital
Name [1] 313490 0
medical ethics board of primary healthcare services of TYPET (Greek acronym of the Mutual Health Fund of National Bank of Greece Personnel)
Address [1] 313490 0
Sofokleous 15, 10551 Athens, Greece
Country [1] 313490 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311418 0
TYPET (Greek acronym of the Mutual Health Fund of National Bank of Greece Personnel)
Ethics committee address [1] 311418 0
Ethics committee country [1] 311418 0
Greece
Date submitted for ethics approval [1] 311418 0
12/10/2020
Approval date [1] 311418 0
19/10/2020
Ethics approval number [1] 311418 0
005294/19-10-2020
Ethics committee name [2] 312479 0
School of Medicine of National and Kapodistrian University of Athens
Ethics committee address [2] 312479 0
Ethics committee country [2] 312479 0
Greece
Date submitted for ethics approval [2] 312479 0
10/06/2020
Approval date [2] 312479 0
19/10/2020
Ethics approval number [2] 312479 0
1920031321/27/07/2020

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

Contacts
Principal investigator
Name 121026 0
Mr Matthaios Petrelis
Address 121026 0
Sokratous 34, 13344 Ano Liosia, Greece
TYPET Physiotherapy Department, Athens, Greece
Country 121026 0
Greece
Phone 121026 0
+306977275939
Fax 121026 0
Email 121026 0
[email protected]
Contact person for public queries
Name 121027 0
Matthaios Petrelis
Address 121027 0
Sokratous 34, 13344 Ano Liosia, Greece
TYPET Physiotherapy Department, Athens, Greece
Country 121027 0
Greece
Phone 121027 0
+306977275939
Fax 121027 0
Email 121027 0
[email protected]
Contact person for scientific queries
Name 121028 0
Matthaios Petrelis
Address 121028 0
Sokratous 34, 13344 Ano Liosia, Greece
TYPET Physiotherapy Department, Athens, Greece
Country 121028 0
Greece
Phone 121028 0
+306977275939
Fax 121028 0
Email 121028 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
No additional documents have been identified.