Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000121561
Ethics application status
Approved
Date submitted
29/09/2023
Date registered
9/02/2024
Date last updated
9/02/2024
Date data sharing statement initially provided
9/02/2024
Date results provided
9/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of Kinesio taping or post-isometric muscle relaxation on pain intensity and stiffness, tension of soft tissue, and ease of movement of the lumbar spine in non-specific low back pain patients.
Scientific title
The effects of Kinesio taping or post-isometric muscle relaxation on pain intensity, soft tissue mechanical properties, and kinematics of the lumbar spine in non-specific low back pain patients.
Secondary ID [1] 310702 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-specific low back pain 331628 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328354 328354 0 0
Physiotherapy
Musculoskeletal 329063 329063 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm-1
The group Kinesio taping underwent a seven-day intervention that included an H-shaped KT of the lumbar spine. The first base was applied at the level of the twelfth rib, and the patch was applied with the participants in a bent forward position with a tension of 15 to 20%. After participants returned to the starting position, the final base was glued at the level of the sacroiliac joints (about 2-3 cm) without tension. The same application was made on the other side of the spine. Finally, the third patch was applied transversely to the first two with a tension correction of 70-80% using the musculoskeletal method, and then the bases of the patch were glued on both sides without generating tension.
The intervention was realized in a private clinic by an experienced physiotherapist in manual therapy. Applications had to be maintained for seven days, with an assessment of tension adherence to the tape by the physiotherapist and corrections in the case.
Arm -2
The group post-isometric relaxation underwent a therapy of the erector spinal muscle, for which they performed three series of self-exercises for seven days. For each treatment series, the participants performed five repetitions of muscle tension and relaxation phases, with a single tension lasting five to seven seconds and the relaxation phase with stretching of the erector spinal muscle lasting three to four seconds.
The participant performed the exercises in the side position while holding their knees with their hands and bending their head. The stretching phase of the back extensor muscles was designed to straighten the whole body, which made it impossible to grip the knees. Meanwhile, the relaxation-stretching phase aimed to maximally bend the whole body and head. At the end of each series, study participants performed a single stimulation of the antagonists by pushing their knees with their hands.
The intervention was realized in a private clinic by an experienced physiotherapist in manual therapy. The film was used to repeat exercises correctly by participants at home.
Intervention code [1] 327103 0
Rehabilitation
Comparator / control treatment
The control group received a placebo Kinesio taping, with the patches applied in an H-shape similar to the KT group (3NS-TEX). The same type of plaster was applied from the level of the twelfth rib to the sacroiliac joints on both sides of the spine and laterally without tension and movement of the participant.
The intervention was realized in a private clinic by an experienced physiotherapist in manual therapy. Applications had to be maintained for seven days, with monitoring adherence to the tape by the physiotherapist and corrections in the case.
Control group
Placebo

Outcomes
Primary outcome [1] 336197 0
Rest pain intensity
Timepoint [1] 336197 0
Before intervention (PRE), seven days after therapy (POST), and after a further seven therapy-free days, to evaluate the effect of the interventions (FOL)
Primary outcome [2] 336198 0
Disability
Timepoint [2] 336198 0
Before intervention (PRE), seven days after therapy (POST), and after a further seven therapy-free days, to evaluate the effect of the interventions (FOL)
Secondary outcome [1] 427294 0
biomechanical properties of soft tissue in the lumbar region of the spine
Timepoint [1] 427294 0
Before intervention (PRE), seven days after therapy (POST), and after a further seven therapy-free days, to evaluate the effect of the interventions (FOL)
Secondary outcome [2] 427295 0
Maximum movement acceleration of the lumbar spine during sit-to-stand and stand-to-sit activity. Both measures will be assessed together as a composite secondary outcome.
Timepoint [2] 427295 0
Before intervention (PRE), seven days after therapy (POST), and after a further seven therapy-free days, to evaluate the effect of the interventions (FOL)

Eligibility
Key inclusion criteria
Patients with chronic pain (duration longer than three months),
non-specific low back pain syndrome,
pain between the last ribs and the buttock fold,
rest pain intensity on the numerical rating scale (NRS) between one and six on the day of examination,
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neurological and rheumatoid diseases,
radiating pain below the buttock fold,
recent post-traumatic orthopedic diseases,
rest pain intensity between seven and ten in the NRS.

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)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study used simple random assignment, by giving every participant in the sample a unique number from sealed envelopes and assigning each participant to one of the research groups undergoing a selected therapeutic intervention: PIR group, KT group, or placebo (KT-PEBO).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Power analysis and sample size selection assumed a clinically significant effect size of 20% change in pain intensity, and a sample size of 20 participants was sufficient to provide a study design with acceptable power (0.8) at P < 0.05. The Shapiro-Wilk test determined the normality of the data distribution. The one-factor parametric/nonparametric ANOVA analyzed the differences between demographics. The three-factor ANOVA was compared between-group means using the main effects of the intervention group (PIR, KT, and KT-PEBO), treatment time (PRE, POST, and FOL), dominant side (D), and contralateral side (OP). The analysis of variance was performed by controlling the observed power and effect size measurements (Eta squared), with an Eta square of 0.01 representing a small effect, 0.06 an average effect, and 0.14 indicating a large effect. The Bonferroni correction method was used for post hoc analysis. The results are graphed as means and 95% confidence intervals. A value of p < 0.05 was assumed to be significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2020
Date of last participant enrolment
Anticipated
Actual
1/03/2021
Date of last data collection
Anticipated
Actual
1/04/2021
Sample size
Target
80
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 25817 0
Poland
State/province [1] 25817 0

Funding & Sponsors
Funding source category [1] 314918 0
University
Name [1] 314918 0
Wroclaw University of Health and Sport Sciences
Country [1] 314918 0
Poland
Primary sponsor type
University
Name
Wroclaw University of Health and Sport Sciences
Address
aleja Paderewskiego 35, 51-612 Wroclaw
Country
Poland
Secondary sponsor category [1] 316925 0
None
Name [1] 316925 0
Address [1] 316925 0
Country [1] 316925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313911 0
Ethical Board Wroclaw University of Health and sport Sciences
Ethics committee address [1] 313911 0
Ethics committee country [1] 313911 0
Poland
Date submitted for ethics approval [1] 313911 0
06/01/2020
Approval date [1] 313911 0
14/02/2020
Ethics approval number [1] 313911 0
14022020

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

Contacts
Principal investigator
Name 129762 0
A/Prof Tomasz Sipko
Address 129762 0
Wroclaw of Health and Sport Sciences, aleja Paderewskiego 35, 51-612 Wroclaw, Poland
Country 129762 0
Poland
Phone 129762 0
+48713473084
Fax 129762 0
Email 129762 0
[email protected]
Contact person for public queries
Name 129763 0
Bernadetta Berger-Pasternak
Address 129763 0
Wroclaw University of Health and Sport Sciences, aleja Paderewskiego 35, 51-612 Wroclaw, Poland
Country 129763 0
Poland
Phone 129763 0
+48713473084
Fax 129763 0
Email 129763 0
[email protected]
Contact person for scientific queries
Name 129764 0
Tomasz Sipko
Address 129764 0
Wroclaw University of Health and Sport Sciences, aleja Paderewskiego 35, 51-612 Wroclaw, Poland
Country 129764 0
Poland
Phone 129764 0
+48609050109
Fax 129764 0
Email 129764 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?
All of the individual participant data collected during the trial will be shared.
When will data be available (start and end dates)?
The data will be available immediately following publication, with no end date.
Available to whom?
The data will be available only to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims of the approved proposal
How or where can data be obtained?
Access is subject to approval by the Principal Investigator
email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20542Ethical approval  [email protected] 386676-(Uploaded-29-09-2023-17-11-26)-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.