To compare the effects of Muscle energy technique and Bowen technique on hamstring tightness in chronic low back pain patients
Design
Pragmatic, community based, parallel group, double blind, randomized controlled trial
Settings and conduct
MADINA TEACHING HOSPITAL FAISALABAD
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• LBP symptoms from more than 3 months
• Both males and females
• Patients complaining of pain of ≥ 5 on NPRS
• Age between 25 to 50 years
• A 20° to 50° loss of active knee extension with hip flexion at 90°
• Study participants who are willing to take part
• A full passive range of knee extension
Exclusion Criteria
• Patients, who have undergone back, pelvis, hip, or knee surgery within the preceding three months, as well as those with any history of lower limb fractures.
• Any radiating pain or prolapsed intervertebral disc-related neurological symptoms
• Patients with co-morbidities other than Chronic Low Back Pain and Hamstrings tightness Pregnancy.
Intervention groups
Total 62 participants having chronic low back pain due to hamstring tightness between 25-50 years will be recruited into the study by convenient sampling. After getting ethical approval from the University of Faisalabad, all the participants will sign consent form and will be added into 2 groups by lottery method. The baseline treatment along with group specific treatment will be given to subjects. The numerical pain rating scale for pain, Active knee extension test for hamstring flexibility and Oswestry low back disability index questionnaire for disability. The treatment will be given for three times per week for four weeks and 12 sessions will be given.
Main outcome variables
ACTIVE KNEE EXTENSION TEST ,NPRS ,OSWESTRY LOW BACK DISABILITY QUESTIONNARE
General information
Reason for update
Acronym
METS ,CLBP,NPRS AKET,ODI
IRCT registration information
IRCT registration number:IRCT20230426057994N1
Registration date:2023-08-07, 1402/05/16
Registration timing:registered_while_recruiting
Last update:2023-08-07, 1402/05/16
Update count:0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Kishwar Batool
Name of organization / entity
Country
Pakistan
Phone
+92 41 5380452
Email address
kishwarbatool1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-02, 1401/12/11
Expected recruitment end date
2023-07-18, 1402/04/27
Actual recruitment start date
2023-08-05, 1402/05/14
Actual recruitment end date
2023-12-01, 1402/09/10
Trial completion date
2023-12-18, 1402/09/27
Scientific title
Comparative Effects of Muscle energy technique and Bowen technique on hamstring muscle tightness in Chronic Low Back Pain patients
Public title
METS vs Bowen technique in hamstring muscle tightness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain more than 12 weeks
20-50 degree Active knee loss
Patients willing to participate
Full passive range of motion of knee extension
Patient complaining of pain >5 on NPRS
Both male and females
Exclusion criteria:
Patients with any history of lower limb injury in past three months
Neurological symptoms involving prolapsed invertebral disc or radiating pain
Any recent abdominal surgery
Pregnancy
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
31
More than 1 sample in each individual
Number of samples in each individual:
3
baseline sample,2nd week and 4th week
Actual sample size reached:
31
More than 1 sample in each individual
Actual sample size in each individual:
3
baseline ,2nd week and 4th week
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization through sealed envelop
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
purposive sampling technique
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ETHICS COMMITTEE OF THE UNIVERSITY OF FAISALABAD
Street address
NO.P-11,ZEENAT BLOCK;MUSLIM TOWN 1;FAISALABAD ,PAKISTAN
City
Faisalabad
Postal code
14496-14535
Approval date
2023-02-03, 1401/11/14
Ethics committee reference number
TUF/Addl Reg/SB/358
Health conditions studied
1
Description of health condition studied
Chronic low back pain with hamstring tightness and comparative effects of Muscle energy technique and Bowen technique
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
NUMERICAL PAIN RATING SCALE
Timepoint
3 DAYS IN WEEK FOR 4 WEEKS
Method of measurement
1-10 POINTS ON PAPER
2
Description
ACTIVE KNEE EXTENSION TEST
Timepoint
3 DAYS IN WEEK FOE4 WEEKS
Method of measurement
GONIOMETER
Secondary outcomes
1
Description
OSWESTRY LOW BACK DISABILITY INDEX
Timepoint
3 TIMES IN AWEEK
Method of measurement
QUESTIONNARE
Intervention groups
1
Description
Interventional Group A (Bowen Technique) 1- First of all, hot pack was applied at the Hamstring muscle and Tens (high frequency 100 Hz pulse duration 60s 10 minutes) was applied at lower back along both were considered as a routine physical therapy. 2-The initial step of the Bowen treatment involved placing the thumb on the surface of the specific muscle.3)The thumb was applied with gentle pressure along the muscle's lateral edge.4- As the thumb was gradually pressed inwards towards the center, the muscles exhibited various responses, such as being pulled, plopped, or demonstrating other observable reactions.5-Manipulate the skin and engage the muscle through controlled movements.6 -The sequence of treatment began with the thumbs and progressed to the fingers.7-Each session of treatment lasted for a duration of 30 minutes .
Category
Treatment - Other
2
Description
Intervention group B: (Muscle Energy Technique) 1-First of all, hot pack was applied at the Hamstring muscle and Tens (high frequency 100 Hz pulse duration 60s 10 minutes) was applied at lower back along with the routine physical therapy. 2-In this technique, the initial step involved extending the subject's knee until they reported experiencing discomfort in the hamstring.3-Following that, a five-second period of moderate isometric contraction of the hamstring muscle was applied. 4-A three-second grace time was allowed. 5-A total of four contractions were performed using this technique. 6-Each session of treatment lasted 30 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MADINA TEACHING HOSPITAL FAISALABAD, PUNJAB, PAKISTAN
Full name of responsible person
DR MUNIR
Street address
Madina teaching hospital sargodha road faisalabad, punjab, pakistan
City
Faisalabad
Postal code
092
Phone
+92 41 8869861
Email
ms.mth@mth.org.pk
Web page address
https://mth.org.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The UNIVERSITY OF FAISALABAD
Full name of responsible person
Kishwar Batool
Street address
Sargodha road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 333 6526682
Email
kishwarbatool1@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
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
THE UNIVERSITY OF FAISALABAD
Full name of responsible person
MARIAM MEHMOOD
Position
Senior Lecturer/ Clinical Coordinator
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madina teaching hospital sargodha road faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 301 4223896
Email
mariam.mehmood@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Mariam Mehmood
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madina teaching hospital Sargodha road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
041
Phone
+92 301 4223896
Email
mariam.mehmood@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Madina Teaching HospitaL
Full name of responsible person
Kishwar Batool
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sargodha road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 333 6526682
Email
kishwarbatool1@gmail.com
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
For concealing participants identity
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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
COMPARATIVE EFFECTS OF MUSCLE ENERGY TECHNIQUE AND BOWEN TECHNIQUE ON HAMSTRINGS MUSCLE TIGHTNESS IN CHRONIC LOW BACK PAIN PATIENTS
When the data will become available and for how long
starting from April 2023
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Data will be available to researchers with valid affiliation to any institute.
From where data/document is obtainable
kishwarbatool1@gmail.com
What processes are involved for a request to access data/document
Inquirer must provide cover letter stating their reason to obtain data and a brief outlook of their research.