Comparison of combined pilates-Kinesio tape and mulligan-Kinesio tape exercises tape on pain, hamstring stiffness, lumbar range of motion, and pelvic tilt in women of nonspecific chronic low back pain
Comparison of combined pilates-Kinesio tape and mulligan-Kinesio tape exercises tape on pain, hamstring stiffness, lumbar range of motion, and pelvic tilt in women of non-specific chronic low back pain
Design
A clinical trial study with parallel groups, open-labeled and phase 3, which will be conducted on 30 participants. Randomization will be done by simple randomization using random numbers table.
Settings and conduct
Women who will be referred for the treatment of low back pain in the orthopedic clinic of Urmia Imam Khomeini Hospital will be included. The study will be an open-label study.
Participants/Inclusion and exclusion criteria
In this study, women with non-specific chronic low back pain will be included. The inclusion criteria will be including persistent back pain for at least 12 weeks; age between 35 to 65 years old; pain intensity between 3-6 based on the visual analogue scale (VAS) and difficulty in bending forward. Participants with pregnancy, narrowing of the canal, lumbar disc, tumor, history of spine surgery, rheumatoid arthritis, and osteoporosis will be excluded.
Intervention groups
Participants in group one will do Pilates exercises three days a week for 6 weeks (one hour each time). The exercises will be 6 to 8 repetitions in the first sessions and 10 to 12 repetitions in the last sessions. In the second group, the participants will receive Mulligan techniques three days a week for 6 weeks (one hour each time), the exercises will be performed with 3 repetitions in the first sessions and 10 repetitions in the last sessions.
Main outcome variables
Pain; hamstring stiffness; lumbar range of motion and pelvic tilt
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211228053554N3
Registration date:2022-09-11, 1401/06/20
Registration timing:prospective
Last update:2022-09-11, 1401/06/20
Update count:0
Registration date
2022-09-11, 1401/06/20
Registrant information
Name
siyamak kazemisofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 9538
Email address
kazemisofi.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combined pilates-Kinesio tape and mulligan-Kinesio tape exercises tape on pain, hamstring stiffness, lumbar range of motion, and pelvic tilt in women of nonspecific chronic low back pain
Public title
The effect of combined pilates-Kinesio tape and mulligan-Kinesio tape exercises on nonspecific chronic low back pain
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Persistent back pain for at least 12 weeks
Age between 35 to 65 years
Pain intensity is between 3-6 based on the visual analogue scale (VAS)
Difficulty in bending forward
Exclusion criteria:
Pregnancy
Narrowing of the canal
Lumbar disc
Tumor
History of spine surgery
Rheumatoid Arthritis
Osteoporosis
Age
From 35 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided into groups using a table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Allameh Tabatabai University
Street address
Allameh Tabatabai University., Village Square., Olympic Village., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Approval date
2022-06-28, 1401/04/07
Ethics committee reference number
IR.ATU.REC.1401.024
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before and 6 weeks after the intervention
Method of measurement
visual analogue scale (VAS)
2
Description
hamstring stiffness
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Straight Leg Raise (SLR) test
3
Description
Lumbar range of motion
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Inclinometer
4
Description
Pelvic tilt
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Tilt meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in group one will do Pilates exercises three days a week for 6 weeks (one hour each time). The exercises will be 6 to 8 repetitions in the first sessions and 10 to 12 repetitions in the last sessions.
Category
N/A
2
Description
Intervention group: In the second group, the participants will receive Mulligan techniques three days a week for 6 weeks (one hour each time), the movements will be performed with 3 repetitions in the first sessions and 10 repetitions in the last sessions.