Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000707268
Ethics application status
Approved
Date submitted
7/03/2018
Date registered
30/04/2018
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Kinesiology Taping on low back pain
Scientific title
The effect of Kinesiology taping application on the resting muscle activity in those with low back pain - randomized controlled trial
Secondary ID [1] 294230 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kinesiology Taping 306895 0
Low Back Pain 306898 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305992 305992 0 0
Physiotherapy
Musculoskeletal 306458 306458 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study will be the analysis of early and distant results of treatment of low
back pain with application kinesiology taping (KT).

Interventional:
Subjects from all three groups receive a routine treatment, including stabilizer training. The tape groups 1 and 2 (KT and Quasi KT) in group C only stabilizer training without KT.

Group (Kinesiology Taping)
In this group KT was applied according to the Kenzo Kaser Kinesio taping manual. The participants assumed standing position to allow forward bending, while the therapist standing behind the participants. Each application will be made using the ligament technology. Depending on the intensity of the pain, the plaster will be stretched in the range of 25 - 50%. KT base has been applied to TH 12 without tension. KT tails go down the spine extender to the sacrum with a tension of 25-50%. The second KT will be applied on laterally at the height of the painful area without tension. The tape will be worn by the participant on a continuous basis and will be changed by the physiotherapist every five days, unless the participant withdraws or shows signs of skin irritation. The application will be for a total period of 10 days.

In groups KT and Quasi KT, patients are to exercise as basic therapy according to the same methodology as described in group control. All three groups receive a individual routine treatment by physiotherapist. Each patient will perform a basic training used to treat low back pain ( continued the same terapy used in hospital). Patient will be checked for presence. for a period of three weeks (without weekends).
Intervention code [1] 300523 0
Rehabilitation
Comparator / control treatment
Group Quasi Kinesiology Taping (Placebo)
In this group was applied non-woven plaster directly to skin without any technique (without stretched). The position for the application is the same as in group Kinesiology Taping. The tape will be worn by the participant on a continuous basis and will be changed by the physiotherapist every five days, unless the participant withdraws or shows signs of skin irritation. The application will be for a total period of 10 days.

Group (control)
Will be treated only with standard kinesitherapy in the form of exercises conducted for 30 minutes a day for 3 weeks (excluding weekends).
Control group
Placebo

Outcomes
Primary outcome [1] 305071 0
Electromyography (sEMG) analisys resting activity muscle erector spinae (mV).
Timepoint [1] 305071 0
Primary endpoint: after 7 days
Rest timepoint:
Before, during and after therapy sessions and follow-up after 24 hours.
Primary outcome [2] 305072 0
Electromyography (sEMG) analysis resting activity muscle multifidus (mV).
Timepoint [2] 305072 0
Primary endpoint: after 7 days
Rest timepoint:
Before, during and after therapy sessions and follow-up after 24 hours.
Primary outcome [3] 305598 0
Posturography analysis the position of posture with open and closed eyes. (COP)
Timepoint [3] 305598 0
Primary endpoint: after 7 days
Rest timepoint:
Before, during and after therapy sessions and follow-up after 24 hours.
Secondary outcome [1] 344085 0
The VAS (Visual Analogue Scale) pain assessment scale was used for subjective assessment of the experienced pain, in which the patient assesses the experienced pain on a simple scale from 0 to 10, where 0 denotes lack of pain and 10 de- notes the strongest pain.
Timepoint [1] 344085 0
Before, during and after therapy sessions and follow-up after 24 hours and 7 days.
Secondary outcome [2] 344086 0
The Lasègue test was used to measure the mobility range in the hip joint on the side of the herniated disc in the course of spinal discopathy. The starting position is lying down on the back with both legs straight. The examiner then slowly lifts one of the patient’s legs while the knee is straight at the joint until pain occurs. The mobility range is measured in angle degrees using a goniometer.
Timepoint [2] 344086 0
Before, during and after therapy sessions and follow-up after 24 hours and 7 days.
Secondary outcome [3] 344087 0
The Schober test was used for evaluation of mobility of the lumbosacral spine. While the patient is in a standing position, the examiner marks 2 points on the patient’s skin: at 10 cm above the line connecting the posterior superior iliac spines, and then at 5 cm below that line. The patient then slowly bends down as far as possible, while keeping the knees straight. The measurement is made using a tape measure. The obtained result is recorded with an accuracy of up to 0.5 cm.
Timepoint [3] 344087 0
Before, during and after therapy sessions and follow-up after 24 hours and 7 days.
Secondary outcome [4] 344090 0
The Roland-Morris Disability Questionnaire (RM) was used to assess the degree of disability in patients with low back pain and re ects the condition of the patient on the day of the examination. The questionnaire contains 24 questions which are answered yes or no. Each yes answer scores 1 point and each no answer scores 0 points. After summing the scores for all questions, the Roland-Morris disability index is as follows: no disability (0–3 points); minimal disability (4–10 points); mod- erate disability (11–17 points); severe disability (18–24 points)
Timepoint [4] 344090 0
Before, during and after therapy sessions and follow-up after 24 hours and 7 days.

Eligibility
Key inclusion criteria
Participating subjects will meet the following inclusion criteria: (1) presented with low back pain (2) provided written informed consent to participate in the study. There will be no restrictions on gender, race, age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with the following conditions will not be allowed to participate or will be excluded from the study: (1) Younger than 18. (2) Currently experiencing a neurovasulcar, vascular or musculoskeletal injury. (3) Currently pregnant. (4) Discopathy at a different level of the spine, (5) No pain. (6) Decreased mobility in the lumbosacral segment. (7) Other diseases within the spine.

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)
Participants will be randomly allocated to the groups. Computer-generated random numbers will be sealed in sequentially numbered envelopes, and the group allocation be independent of the time and person delivering the treatment. The physician (research coordinator) who will allocate the subjects to groups have envelopes, each containing a piece of paper marked with either group 1, 2 or 3. The physician will select and open an envelope in the presence of a physiotherapist to see the symbol and then direct the patient to the corresponding group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer and numbered envelopes
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
The obtained results will be subjected to statistical analysis made with the STATISTICA software. Power analysis in each group will be required and calculated to establish the statistical significance with a = 0.05 and power = 0.80 based on the estimated outcomes of 85% for therapeutic method. For measurable variables, the arithmetic mean, standard deviation, medians and extreme values (minimum and maximum) will be calculated. However for qualitative variables, the occurrence rates, will be expressed as a percentage. Homogeneity of the compared groups will be established in terms of selected characteristics of the participants, and the level of significance will be accepted at p>0.05. Results will be compared between the groups with comparative tests (independent), as well as each group results obtained before and after therapy (dependent tests). The type of statistical tests will be depend on the fulfilment of their objectives. Statistically significant differences at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
2/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2019
Actual
Sample size
Target
60
Accrual to date
23
Final
Recruitment outside Australia
Country [1] 9658 0
Poland
State/province [1] 9658 0
Opolskie, Opole

Funding & Sponsors
Funding source category [1] 298902 0
Self funded/Unfunded
Name [1] 298902 0
Tomasz Matusz
Country [1] 298902 0
Poland
Primary sponsor type
University
Name
Department of Physiotherapy, Medical Higher School in Opole
Address
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country
Poland
Secondary sponsor category [1] 298117 0
None
Name [1] 298117 0
Address [1] 298117 0
Country [1] 298117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299810 0
Ethics committee medical university in Wroclaw
Ethics committee address [1] 299810 0
Ethics committee country [1] 299810 0
Poland
Date submitted for ethics approval [1] 299810 0
21/12/2017
Approval date [1] 299810 0
18/01/2018
Ethics approval number [1] 299810 0
KB 794/2017

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

Contacts
Principal investigator
Name 81634 0
Dr Tomasz Matusz
Address 81634 0
Department of Physiotherapy, Medical Higher School in Opole
Opole 45-060
Katowicka 68 street
Country 81634 0
Poland
Phone 81634 0
+ 48 508721632
Fax 81634 0
Email 81634 0
[email protected]
Contact person for public queries
Name 81635 0
Tomasz Matusz
Address 81635 0
Department of Physiotherapy, Medical Higher School in Opole
Opole 45-060
Katowicka 68 street
Country 81635 0
Poland
Phone 81635 0
+48 508721632
Fax 81635 0
Email 81635 0
[email protected]
Contact person for scientific queries
Name 81636 0
Tomasz Matusz
Address 81636 0
Department of Physiotherapy, Medical Higher School in Opole
Opole 45-060
Katowicka 68 street
Country 81636 0
Poland
Phone 81636 0
+ 48 508 721 632
Fax 81636 0
Email 81636 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
Supervisor decision.


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.