Investigating the effects of adding kinesio taping to diaphragm strengthening exercise on pain, function and balance in women athletes with chronic non-specific low back pain
The aim of this study is to investigate the effect of adding taping to diaphragm strengthening exercises on pain, function and balance of women athletes with non-specific chronic low back pain compared to the control group.
Design
A randomized clinical trial with parallel, controlled, single blind groups, single phase on 32 patients, Online randomizer software and permutation method will be used for randomization.
Settings and conduct
In this study, 32 female athletes with non-specific chronic low back pain who refer to the physiotherapy clinic of Shiraz Rehabilitation Faculty from clubs scattered throughout the city will be randomly divided into two groups. The first group will receive tapping along with diaphragm strengthening exercises and the second group will receive only diaphragm strengthening exercises.
Participants/Inclusion and exclusion criteria
This study was conducted on female recreational athletes (30-50 years old) in the profession of bodybuilding with chronic non-specific low back pain. People who have a history of lung diseases or who are prohibited from using taping, are excluded from the study.
Intervention groups
Diaphragm strengthening exercises group: people with non-specific chronic low back pain who only receive diaphragm strengthening exercises. The considered strengthening breathing exercises are performed 2 times a day and at least 5 days a week for 4 weeks. Diaphragm strengthening exercises group with taping: People with non-specific chronic back pain who, in addition to strengthening breathing exercises according to the control group, received diaphragm muscle tapping every 4 days for 4 weeks. Samples from fitness clubs scattered throughout the city are included in the study.
Main outcome variables
Pain, function and balance level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190909044734N5
Registration date:2023-09-05, 1402/06/14
Registration timing:prospective
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Leila Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
leabbasi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of adding kinesio taping to diaphragm strengthening exercise on pain, function and balance in women athletes with chronic non-specific low back pain
Public title
The effects of adding diaphragm kinesio taping to strengthening exercise on pain, function and balance in women athletes with chronic non-specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent
Female gender
Recreational bodybuilding athletes who exercise between 4-6 hours a week
Age range from 30 to 50 years old
The numerical score of the pain scale at the time of entering the study and the average of 1 week should be between3-7
Disability score of 50 or less based on ODI questionnaire
Pain in the lower back for at least 3 months(12 weeks) or more
Exclusion criteria:
History of known lung diseases
History of cardiovascular surgery
Chronic bronchitis
Lung cancer
Spondylolisthesis, fracture of the spine or history of its surgery
Radicular low back pain
Inflammatory backaches
Neuropathy and myopathy
History of rib fracture
Surgery or thoracic fracture and abdominal surgery
Cognitive and psychological change
Patients with musculoskeletal abnormalities
Pregnancy
Spinal canal stenosis and previous spinal surgery
People with cough and upper respiratory symptoms starting in the last few days
Infection and inflammation in the thoracic region
diabetes
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In order to perform a random sequence with the help of randomizer software, permutation randomization method is used, in which 4 blocks (8 blocks) are prepared based on the total number of participants. In order to hide the random allocation by using non-transparent sealed envelopes which are prepared in advance according to the number of the sample size of the study and keeping the random sequence, in the meeting when the person enters the study to collect data, one is taken and By opening that block and the desired group of the person is determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who will evaluate the patients and analyze the data is completely unaware of details of the patient grouping and the treatments performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, Shiraz Faculty of Rehabilitation Sciences
Street address
Abiverdi Street 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345- 1733
Approval date
2023-07-26, 1402/05/04
Ethics committee reference number
IR.SUMS.REHAB.REC.1402.013
Health conditions studied
1
Description of health condition studied
Non-specific chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention, immediately after the end of the treatment (end of the fourth week) and two weeks after the end of the treatment as a follow-up.
Method of measurement
Numeric pain rating scale
2
Description
Function
Timepoint
Before the intervention, immediately after the end of the treatment (end of the fourth week) and two weeks after the end of the treatment as a follow-up.
Method of measurement
Oswestry disability questionnaire/Athletes disability index
3
Description
Static balance
Timepoint
Before the intervention, immediately after the end of the treatment (end of the fourth week) and two weeks after the end of the treatment as a follow-up.
Method of measurement
Single leg stance
4
Description
Dynamic balance
Timepoint
Before the intervention, immediately after the end of the treatment (end of the fourth week) and two weeks after the end of the treatment as a follow-up.
Method of measurement
Y balance test
5
Description
Core muscle endurance
Timepoint
Before the intervention, immediately after the end of the treatment (end of the fourth week) and two weeks after the end of the treatment as a follow-up.
Method of measurement
Prone plank test/Lateral plank test/Unilateral hip bridge test/Feet elevated side support test
6
Description
Agility of athletes
Timepoint
Before the intervention, immediately after the end of the treatment (end of the fourth week) and two weeks after the end of the treatment as a follow-up.
Method of measurement
Illinois agility test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Strengthening exercises with diaphragm tapping: People with non-specific chronic low back pain who in addition to diaphragm strengthening exercises according to the control group, receive diaphragm tapping every 4 days for 4 weeks.
Category
Rehabilitation
2
Description
Control group: Diaphragm strengthening exercises group: People with non-specific chronic low back pain who receive diaphragm strengthening exercises as 2 exercises per week for 4 weeks that according to the weekly schedule, they do each for 5 minutes, 2 times a day and 5 days a week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation
Full name of responsible person
Leila Abbasi
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1552
Fax
+98 71 3627 2495
Email
leabbasi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Research Deputy, Central building of Shiraz University of Medical Sciences, Opposite Palestine St, Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
leabbasi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
leabbasi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
Email
leabbasi@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD