Protocol summary

Study aim
To compare the effectiveness of muscle energy technique versus kinesiotaping on mobility, pain kinesiophobia in information technology professionals with ergonomic related low back pain.
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 30 patients enrolled.
Settings and conduct
• The University of Faisalabad • Superior University Faisalabad Campus
Participants/Inclusion and exclusion criteria
Both male and female patients of low back pain with the age of 20-40 years was selected after meeting the inclusion and exclusion criteria
Intervention groups
1: muscle energy technique 2: kinesiotaping
Main outcome variables
Pain Mobility Kinesiophobia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240610062080N1
Registration date: 2024-08-03, 1403/05/13
Registration timing: retrospective

Last update: 2024-08-03, 1403/05/13
Update count: 0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
Sumbal Sohail
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 2699533
Email address
2022-ms-pt-059@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-01, 1402/12/11
Expected recruitment end date
2024-06-01, 1403/03/12
Actual recruitment start date
2024-03-01, 1402/12/11
Actual recruitment end date
2024-06-01, 1403/03/12
Trial completion date
2024-06-25, 1403/04/05
Scientific title
Comparative effects of muscle energy technique versus kinesiotaping on pain, mobility and kinesiophobia in information technology professionals with ergonomic related low back pain
Public title
Comparative effects of muscle energy technique versus kinesiotaping on pain, mobility and kinesiophobia in information technology professionals with ergonomic related low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 22 to 40 years Gender both male and female Pain score greater than 4 on VAS Experiencing WRLBP more than 90 days
Exclusion criteria:
H/O of spinal surgeries Fracture Cancer Spondylolisthesis Serious cardio-respiratory disease Spinal stenosis Neuropathic pain
Age
From 22 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is simple. Participants were randomly divided into two groups named as group A and group B by lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
when participants in the study do not know which group they have been allocated to, intervention or control
Placebo
Not used
Assignment
Parallel
Other design features
Randomized clinical Trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The University of Faisalabad
Street address
Faisal Town, West Canal Road
City
Faisalabad
Postal code
38000
Approval date
2024-01-05, 1402/10/15
Ethics committee reference number
TUF/AddI Reg/SB/778

Health conditions studied

1

Description of health condition studied
Ergonomic related Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
The first outcome goal was Pain checked using the visual analog scale, an effective and accurate tool for measuring pain in patients with low back pain. The VAS is a 10-centimeter scale, with 0 showing no pain and 10 means severe pain.
Timepoint
Total 3 readings were taken during the whole treatment. First was taken before treatment as a baseline reading. Then second reading was taken by post 2 week. Same as third reading was noted after 4th week.
Method of measurement
By using Visual Analogue Scale

Secondary outcomes

1

Description
Mobility and kinesophobia
Timepoint
First reading was taken before treatment as a baseline reading. Then second reading was taken by post 2 week. Same as third reading was noted after 4th week. Total 3 readings were taken during the whole treatment.
Method of measurement
Mobility by schober test , Kinesophobia by TAMPA scale

Intervention groups

1

Description
15 participants in group A were treated by kinesio taping plus conventional physical therapy. Conventional physical therapy includes dry heat and lumbar stabilization exercises as a baseline treatment. All the participants in group A were taped by physicians. It was lasted for 4 days before it was replaced. Taping was applied 3 times (baseline 4th , 8th days). Patients were instructed to keep the tape on between taping sessions. This procedure consisting a total period of 12 days.
Category
Rehabilitation

2

Description
Group B consisting of 15 participants were treated with muscle energy technique plus conventional physical therapy. Conventional physical therapy includes dry heat and lumbar stabilization exercises as a baseline treatment. Muscle energy technique was applied in the form of PIR on psoas group, hamstring, tensor fascia Lata, piriformis, quadratus lumborum and erector spinae muscles by holding 7-10s with 4 repetitions. The treatment of this group went for one month under 3 training / week. The readings for different outcome variables measured on 2nd and 4th week respectively.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
The University of Faisalabad
Full name of responsible person
Sumbal Sohail
Street address
Faisal Town, West Canal Road
City
Faisalabad
Postal code
38000
Phone
+92 41 8750971
Fax
Email
studentaffairsew@tuf.edu.pk
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sumbal Sohail
Street address
Rangeela Chowk House no.1147-DA GM Abad Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 334 6782341
Email
sumbalsohai118@gmail.com.pk
Grant name
The University of Faisalabad
Grant code / Reference number
TUF/AddI Reg/SB/778
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
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sumbal Sohail
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Rangeela Chowk House no.1147-DA GM Abad Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 6782341
Email
sumbalsohai118@gmail.com.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Mahvish Musharaf Randhawa
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rangeela Chowk House no.1147-DA GM Abad Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 300 8222334
Email
zainy.fatima@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sumbal Sohail
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rangeela Chowk House no.1147-DA GM Abad Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 6782341
Email
sumbalsohai118@gmail.com.pk

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be provided by contacting on g mail.
When the data will become available and for how long
Data will be provided by contacting on g mail.
To whom data/document is available
Data will be provided by contacting on g mail.
Under which criteria data/document could be used
Data will be provided by contacting on g mail.
From where data/document is obtainable
Data will be provided by contacting on g mail.
What processes are involved for a request to access data/document
Data will be provided by contacting on g mail.
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