1. To evaluate the impact of Pilates exercises on pain on people who have non-specific low back pain
2. To evaluate the effect of Pilates exercises on lumbar ROM in individuals with non-specific low back pain
Design
Randomized clinical trial with blinded outcome assessment. 30 male and female participants were randomly allocated into control and experimental groups.
Settings and conduct
Study settings were OPDs of Madinah teaching hospital and Allied hospital Faisalabad. The trial was blinded by both the researcher and the participants as someone else has allocated the participants in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria was to have individuals with chronic low back pain aging between 30-50 years.
Exclusion criteria was pregnancy, any spinal pathology.
Intervention groups
Intervention group received hotpack as the baseline treatment then the participants had performed a set of Pilates exercise program which included 8 different exercises that basically targeted the core and lower back muscles while incorporating both mind and body.
Main outcome variables
Numeric pain rating scale and Modified Schober test were the main outcome measures. NPRS was to assess the pain and Modified Schober Test was used to assess the lumbar range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221006056105N1
Registration date:2022-10-11, 1401/07/19
Registration timing:retrospective
Last update:2022-10-11, 1401/07/19
Update count:0
Registration date
2022-10-11, 1401/07/19
Registrant information
Name
Saman Salahuddin
Name of organization / entity
Madinah Teaching Hospital Faisalabad
Country
Pakistan
Phone
+92 337 7002916
Email address
hashmisaman88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-15, 1400/12/24
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
2022-03-20, 1400/12/29
Actual recruitment end date
2022-05-26, 1401/03/05
Trial completion date
2022-05-26, 1401/03/05
Scientific title
Effects Of Pilates Exercises As A Treatment Approach In Patients With Non-specific Low Back Pain
Public title
Effects Of Pilates Exercises For Non-specific Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
LBP that has proceeded longer than 3 months
Male and female participants aging between 30-50 years
Participants having complain of 3 to 7 score on NPRS
No leg symptoms in last week
No recent surgery in past 6 months
Exclusion criteria:
Pregnancy (all trimesters)
Any history of spinal fracture
Participants having pain due to other pathology (diagnostic triage for LBP)
Ankylosing Spondylitis
Participants enrolled in regular exercise programs
Age
From 30 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The method used for randomization was chit and draw method. In this method, chits are prepared and assigned some numbers then they are randomly drawn to allocate participants in either of the two groups. Randomization was used to avoid biasness.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were blinded in the study so that they did not know in which they were sent into. Blinding was done in order to avoid placebo effect. The participants were unaware of the treatmenr protocol given in both groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of The University Of Faisalabad
Street address
Sargodha Road, University Town, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2022-06-19, 1401/03/29
Ethics committee reference number
7007
Health conditions studied
1
Description of health condition studied
Non-specific Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Numeric Pain Rating Scale
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
It is a subjective 10 point pain assessment scale that a person describes according to his/her pain intensity.
Secondary outcomes
1
Description
Modified Schober Test
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
It is a test used to measure lumbar flexion and extension. A line was drawn 5 cm below and 10cm above the level of posterior superior iliac spine and the patients were instructed to forward flex and touch the toes, the measurements were taken using a measuring tape.
Intervention groups
1
Description
The participants of experimental/interventional group received hot pack as baseline treatment then performed Pilates exercises as treatment adjunct for 4 weeks of duration, 2 sessions per week. Measurements of pain intensity, lumbar range of motion were recorded at first and last session with measuring tools. The Pilates exercises program included Diaphragmatic breathing (as a warm up, slowly inhale and exhale as much as the patient could perform), The hundred (4 reps, 30 secs each), Roll up (5 reps, 30 secs), Spine stretch (5 reps with 2 minutes of recovery period within each rep), Single leg circles (5 reps each leg), Single leg circles with bent leg (5 reps for each leg), Single leg stretch (5 reps for each leg) and Diaphragmatic breathing ( to cool down the patient).
Category
Rehabilitation
2
Description
The participants of control group recieved hotpack as the baseline treatment and then they were instructed to continue their activities of daily living for 4 weeks, 2 sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Saman Salahuddin
Street address
P 175, Shadman Town, Sargodha Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 337 7002916
Email
hashmisaman88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Saman Salahuddin
Street address
P 175, Shadman Town, Sargodha Road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 337 7002916
Email
hashmisaman88@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University Of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
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
Madinah Teaching Hospital
Full name of responsible person
Saman Salahuddin
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P 175, Shadman Town, Sargodha Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 337 7002916
Email
hashmisaman88@gmai.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Madinah Teaching Hospital Faisalabad
Full name of responsible person
Saman Salahuddin
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P 175 Shadman Town Sargodha Road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 337 7002916
Fax
Email
hashmisaman88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Madinah Teaching Hospital Faisalabad
Full name of responsible person
Saman Salahuddin
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P 175 Shadman Town Sargodha Road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 337 7002916
Fax
Email
hashmisaman88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available