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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

non-specific low back pain

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

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]

Rest pain intensity

Timepoint [1]

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]

Disability

Timepoint [2]

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]

biomechanical properties of soft tissue in the lumbar region of the spine

Timepoint [1]

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]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Wroclaw University of Health and Sport Sciences

Address [1]

aleja Paderewskiego 35, 51-612 Wroclaw

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Board Wroclaw University of Health and sport Sciences

Ethics committee address [1]

aleja Paderewskiego 35, 51-612 Wroclaw

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

06/01/2020

Approval date [1]

14/02/2020

Ethics approval number [1]

14022020

Summary

Brief summary

This study measured the biomechanical properties of soft tissue and kinematics of the lumbar spine in response to specific physiotherapeutic interventions: kinesio taping or placebo or post-isometric relaxation exercises in the low back pain population. The aim was to determine intervention effects subjectively and objectively. The study hypothesis stated that applying kinesio taping or post-isometric relaxation exercises reduced pain intensity at rest, and increased muscle tone and stiffness but decreased relaxation time in tissue viscoelasticity, and improved kinematics of the lumbar spine in low back patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Tomasz Sipko

Address

Wroclaw of Health and Sport Sciences, aleja Paderewskiego 35, 51-612 Wroclaw, Poland

Country

Poland

Phone

+48713473084

Fax

tomasz.sipko@awf.wroc.pl

Contact person for public queries

Name

Bernadetta Berger-Pasternak

Address

Wroclaw University of Health and Sport Sciences, aleja Paderewskiego 35, 51-612 Wroclaw, Poland

Country

Poland

Phone

+48713473084

Fax

bernadetta.berger@gmail.com

Contact person for scientific queries

Name

Tomasz Sipko

Address

Wroclaw University of Health and Sport Sciences, aleja Paderewskiego 35, 51-612 Wroclaw, Poland

Country

Poland

Phone

+48609050109

Fax

tomasz.sipko@awf.wroc.pl

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: tomasz.sipko@awf.wroc.pl

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20542	Ethical approval			tomasz.sipko@awf.wroc.pl		386676-(Uploaded-29-09-2023-17-11-26)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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