Objectives: Non-specific chronic low-back pain (NCLBP) is an important public health challenge worldwide and, despite the volume of literature published on the subject, it is still a difficult-to-treat condition. Kinesio taping is one of the new methods induced in the treatment of low back pain. But it is under the question which is the impact of these procedure on the lumbar and abdominal muscles endurance. This study is aimed to identify the acute effects of kinesio tape on the abdominal muscle using endurance tests in NCLBP.
Design: 26 patients with NCLBP and 26 healthy non-athletes were recruited. This was a single-blind crossover trial consisting of two sessions of taping (real and sham) with 2 days apart in 26 patients. The order of receiving the taping technique was conducted by dividing the participants into two groups (real/sham & sham/real) randomly.
Setting and conduct: All subjects in three groups (one healthy and two patients groups) were evaluated by muscle endurance using three tolerance tests and were repeated pre/post kinesio taping in patients . Then in the next session, tests were repeated and patients were compared with healthy participants.
Participants including major eligibility criteria: 1-Non-specific Chronic Low Back Pain (LBP persisting for more than 3 months in the absence of an underlying pathology); 2- age between 18 and 45 years; 3- pain between 3 and 6 on visual analogue scale (VAS), exclusion criteria: 1- history of abdominal surgery; 2- abdominal hernia; 3- pregnancy.
Intervention: interventions were included two approaches: 1- three I-strips Kinesio tape applying to 50% of maximum recoil on the abdominal muscles 2- one I-strip tape applying under no tension in the area above the umbilicus.
Main outcome measures variables: 1- Supine double straight-leg raise (SDSLR) test. 2- Supine isometric chest raise (SICR) test. 3- Abdominal drawing in maneuver.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110829264N2
Registration date:2016-11-29, 1395/09/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-29, 1395/09/09
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-08, 1395/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the acute effect of abdominal muscle taping on endurance tests in patients with non specific chronic low back pain
Public title
evaluation of the acute effect of abdominal muscle taping in patients with non specific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
1-Non specific Chronic Low Back Pain (LBP persisting for more than 3 months in the absence of an underlying pathology);
2- age between 18 and 45 years;
3- pain between 3 and 6 on visual analogue scale (VAS),
exclusion criteria:
1- history of abdominal surgery;
2- abdominal hernia;
3- pregnancy.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
this study is one part of master thesis with registration number of (PZ 2863 322) developed in 2011. this thesis is fully traceable with ethic registration number of 5299424 from Medical Ethics Committee of the tarbiat modares university.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Tarbiat Modares university
Street address
Jalal Al Ahmad street ,Tehran.
City
Tehran
Postal code
Approval date
2011-02-26, 1389/12/07
Ethics committee reference number
5299424
Health conditions studied
1
Description of health condition studied
chrionic low back pain
ICD-10 code
M54.5
ICD-10 code description
Loin pain, Low back strain
Primary outcomes
1
Description
Supine isometric chest raise test
Timepoint
before and after taping
Method of measurement
The maximal hold time in seconds
2
Description
Supine double straight-leg raise test
Timepoint
before and after taping
Method of measurement
The maximal hold time in seconds
3
Description
Abdominal drawing in maneuver
Timepoint
before and after taping
Method of measurement
The maximal hold time in seconds
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: 1- Supine isometric chest raise (SICR) test
The participant's position was supine on the treatment table with the hands crossed on his/her chest. The hips and knees were flexed at 45° and the feet were placed flat on the table. The participant was requested to lift neck and upper trunk from the table until the inferior angles of scapulae had risen clear of the table and hold this position as long as possible. The maximal hold time was then recorded in seconds, and the test was terminated when the participant was unable to maintain the test position.
2-Supine double straight-leg raise (SDSLR) test
The participant was asked to lie in a supine position with the hips and knees extended. The hands were also placed in a relaxed position near his/her body. The participant was then instructed to raise both legs from the table to approximately 20° and hold them as long as possible without any tilting in the pelvis. During the test, pelvic tilt was monitored by an experienced physical therapist. The maximal hold time was recorded in seconds, and the test was terminated when the participant was unable to maintain knee clearance.
3-Abdominal drawing in maneuver
This was done with the participant lying supine on the treatment table with the hands were placed in a relaxed position near the body. The hips and knees were flexed at 45° and the feet were placed flat on the table. In addition, a pressure biofeedback monitor (sphygmomanometer) was placed below the lumbar lordosis between the L1 and S1 vertebrae. The cuff of the sphygmomanometer was inflated to 20 mmHg using an air pump to fill the space between the lumbar spine and treatment table. The participant was then requested to contract his/her deep abdominal musculature by drawing the navel up in a cephalad direction and in toward the spine. The participant was instructed to push his/her back against the cuff and maintain the pressure at 40 (±10) mmHg as long as possible. The maximal hold time was recorded in seconds, and the test was terminated when the participant was unable to maintain the pressure at 40 (±10) mmHg.
4-Taping techniques
The NCLBP participants were asked to lie in a supine position and their hips and knees were flexed at 45°. Depending on the NCLBP participant’s morphology, the length of three pieces of I-shaped strip Kinesio tape was determined by measuring the distance between two anterior superior iliac spines (ASISs) and measuring the distance between the middle one-third of the intermediate line of the iliac crest to the inferior border of the 10th rib. Afterward, the Kinesio tapes were applied to the internal oblique muscles in the direction of the fibers from the origin to insertion with approximately 50% of their maximal length tension. For the transversus abdominus muscle, the Kinesio tape was applied horizontally between the two ASISs with approximately 50% of maximal length tension . Then, all of the measurements were repeated again in the same manner as they had been performed before taping.
Category
Rehabilitation
2
Description
placebo group: 1- Supine isometric chest raise (SICR) test The participant's position was supine on the treatment table with the hands crossed on his/her chest. The hips and knees were flexed at 45° and the feet were placed flat on the table. The participant was requested to lift neck and upper trunk from the table until the inferior angles of scapulae had risen clear of the table and hold this position as long as possible. The maximal hold time was then recorded in seconds, and the test was terminated when the participant was unable to maintain the test position. 2-Supine double straight-leg raise (SDSLR) test The participant was asked to lie in a supine position with the hips and knees extended. The hands were also placed in a relaxed position near his/her body. The participant was then instructed to raise both legs from the table to approximately 20° and hold them as long as possible without any tilting in the pelvis. During the test, pelvic tilt was monitored by an experienced physical therapist. The maximal hold time was recorded in seconds, and the test was terminated when the participant was unable to maintain knee clearance. 3-Abdominal drawing in maneuver This was done with the participant lying supine on the treatment table with the hands were placed in a relaxed position near the body. The hips and knees were flexed at 45° and the feet were placed flat on the table. In addition, a pressure biofeedback monitor (sphygmomanometer) was placed below the lumbar lordosis between the L1 and S1 vertebrae. The cuff of the sphygmomanometer was inflated to 20 mmHg using an air pump to fill the space between the lumbar spine and treatment table. The participant was then requested to contract his/her deep abdominal musculature by drawing the navel up in a cephalad direction and in toward the spine. The participant was instructed to push his/her back against the cuff and maintain the pressure at 40 (±10) mmHg as long as possible. The maximal hold time was recorded in seconds, and the test was terminated when the participant was unable to maintain the pressure at 40 (±10) mmHg. 4-Taping techniques The NCLBP participants were asked to lie in a supine position and their hips and knees were flexed at 45°. Depending on the NCLBP participant’s morphology, the length of one pieces of I-shaped strip Kinesio tape was determined by measuring the distance between inferior border of the 10th rib bilaterally. Afterward, the Kinesio tape were applied to the inferior margin of 10th ribs above the umbilicus under no tension. Then, all of the measurements were repeated again in the same manner as they had been performed before taping.
Category
Treatment - Drugs
3
Description
healthy group 1- Supine isometric chest raise (SICR) test The participant's position was supine on the treatment table with the hands crossed on his/her chest. The hips and knees were flexed at 45° and the feet were placed flat on the table. The participant was requested to lift neck and upper trunk from the table until the inferior angles of scapulae had risen clear of the table and hold this position as long as possible. The maximal hold time was then recorded in seconds, and the test was terminated when the participant was unable to maintain the test position. 2-Supine double straight-leg raise (SDSLR) test The participant was asked to lie in a supine position with the hips and knees extended. The hands were also placed in a relaxed position near his/her body. The participant was then instructed to raise both legs from the table to approximately 20° and hold them as long as possible without any tilting in the pelvis. During the test, pelvic tilt was monitored by an experienced physical therapist. The maximal hold time was recorded in seconds, and the test was terminated when the participant was unable to maintain knee clearance. 3-Abdominal drawing in maneuver This was done with the participant lying supine on the treatment table with the hands were placed in a relaxed position near the body. The hips and knees were flexed at 45° and the feet were placed flat on the table. In addition, a pressure biofeedback monitor (sphygmomanometer) was placed below the lumbar lordosis between the L1 and S1 vertebrae. The cuff of the sphygmomanometer was inflated to 20 mmHg using an air pump to fill the space between the lumbar spine and treatment table. The participant was then requested to contract his/her deep abdominal musculature by drawing the navel up in a cephalad direction and in toward the spine. The participant was instructed to push his/her back against the cuff and maintain the pressure at 40 (±10) mmHg as long as possible. The maximal hold time was recorded in seconds, and the test was terminated when the participant was unable to maintain the pressure at 40 (±10) mmHg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of medicine
Full name of responsible person
Mohammad Reza Pourahmadi
Street address
Tarbiat Modares university, Jalal Al Ahmad street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Tarbiat Modares University
Full name of responsible person
Mohammad Reza PourAhmadi
Street address
Madakaran alley, Shahnazari street, Madar squar.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Seyyed Rasoul Bagheri
Position
Ph.D candidate of Physiotherapy
Other areas of specialty/work
Street address
Madadkaran Alley, Shahnazari Street, Madar Squar.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
rasool.bagheri@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Pourahmadi
Position
Ph.D
Other areas of specialty/work
Street address
Madadkaran Alley, Shahnazari Street, Madar Squar.
City
Tehran
Postal code
Phone
+98 21 7783 6545
Fax
Email
pourahmadipt@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Seyyed Rasoul Bagheri
Position
Ph.D Candidate
Other areas of specialty/work
Street address
Madadkaran Alley, Shahnazari Street, Madar Squar.
City
Tehran
Postal code
Phone
+98 21 7783 6545
Fax
Email
rasool.bagheri@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)