The main objective of this study is to compare the effects of static stretching with and without neurodynamics on range of motion, pain and functional ability in females with hamstrings tightness.
Design
A concealed, double blinded, randomized controlled trail with a parallel group design of 62 participants, enrolled between July 2021 and January 2022 And followed for one month.
Settings and conduct
females of University of Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1.Female participants with hamstring tightness
2.Aging between 18 and 30 years
3.Participants with knee extension ≤ 20°.
Non-inclusion Criteria:
Patient having history of
1.Neurological disorders
2.Orthopedic diseases (Osteoarthritis, Rheumatoid Arthritis, Spondylolisthesis)
3.Hamstrings injury or strain
4.Chronic Low back pain
5.Any recent spinal surgery history
Intervention groups
Participants will randomly allocated to two different group each contain 31 participants. Group A receive neurodynamics along with static stretching while group B receive only static stretching. Both interventions will be applied for 6 days and followups will be done after 1 month.Then Results of both interventions will be compared.
Main outcome variables
Pain;
Range of motion;
Functional ability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210705051796N1
Registration date:2022-03-07, 1400/12/16
Registration timing:retrospective
Last update:2022-03-07, 1400/12/16
Update count:0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
NAYAB JOHN
Name of organization / entity
UNIVERSITY OF LAHORE
Country
Pakistan
Phone
+92 53 3705255
Email address
drnayab73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-27, 1400/05/05
Expected recruitment end date
2022-01-26, 1400/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of static stretching with and without neurodynamics on range of motion, pain and functional ability in females with hamstrings tightness
Public title
Effects of static stretching with and without neurodynamics on range of motion, pain and functional ability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female participants with hamstring tightness
Aging between 18 and 30 years
Participants with knee extension ≤ 20°
Exclusion criteria:
Neurological disorders
Orthopedic diseases (Osteoarthritis, Rheumatoid Arthritis, Spondylolisthesis)
Hamstrings injury or strain
Chronic Low back pain
Any recent spinal surgery history
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Computer generated randomization assignment will be designed by an independent statistician and randomization will be done by one of the research team members who will not be the part of any intervention, assessment or data analysis. Randomization assignments will be kept in opaque. Outcome assessors will be unaware of group assignment. The intervention will be started on the day after randomization, for both group.For both groups the intervention will be continue for 5 consecutive days and reading should be taken before and after applying intervention and followup will be done after one month .
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, care provider , outcome assessor, data analyser and investigator will be unaware of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of The University of Lahore
Street address
1 km Raiwand Road, The University of Lahore
City
Lahore
Postal code
40050
Approval date
2021-11-22, 1400/09/01
Ethics committee reference number
IRB-UOL-FAHS/993/2021
2
Ethics committee
Name of ethics committee
Ethical Committee of The University of Lahore Institutional Review Board
Street address
1 km Raiwand Road, The University of Lahore
City
Lahore
Postal code
40050
Approval date
2021-11-22, 1400/09/01
Ethics committee reference number
IRB-UOL-FAHS/993/2021
Health conditions studied
1
Description of health condition studied
Hamstrings Tightness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Range of motion
Timepoint
Outcomes will be checked at baseline before apply intervention and after applying intervention on conservative 5 day and followup should be done after 1 month .
Method of measurement
Goniometer.
2
Description
Pain
Timepoint
Pain will be assess by using Visual analog scale . Before and after applying intervention for 5 consecutive days,and followup will be done after one month .
Method of measurement
Numeric pain rating scale
3
Description
Functional ability
Timepoint
Functional abilities will be measured on daily bases .Base line reading will be measured and then after applying intervention again the reading will be taken, this will be continue for 5 consecutive days (DAY 1, DAY 2 , DAY 3, DAY 4, DAY 5 )and after 1 month again the functional ability will be measured.
Method of measurement
The Lower Extremity functional scale (LEFS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Participants will receive neurodynamics along static stretching (NS-SS) of hamstring musculature. Subjects in lying supine and their neck and thoracic spine supported in a forward flexed position. Concurrent hip and knee flexion were alternated dynamically with concurrent hip and knee extension. The therapist alternated the combination of movement depending on the tissue resistance level. This combination of movements was performed for 180 seconds on their dominant lower extremity. This position will then maintained for 30 seconds consisted of six sets of 30 s with a 60 s rest between sets and repeated 5 times further on conservative days and then follow up after 1 month.
Category
Treatment - Other
2
Description
Intervention group 2 : Participants will receive only static stretching (SS) of the hamstring muscles in their dominant leg. While subjects in lying supine, the dominant lower extremity would passively position into SLR position (hip in flexion, knee in extension and ankle in neutral) without pain/discomfort to the point where resistance to the movement will first noted. This position will then maintained for 30 seconds consisted of six sets of 30 s with a 60 s rest between sets and repeated 5 times further on conservative days and then follow up after 1 month. During the 30 second stretches, the therapist monitored the subject to ensure they did not make any compensation that could modify the stretching position. Each subject had a total of 180 seconds of stretching on their lower extremity.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Lahore
Full name of responsible person
Nayab John
Street address
1 km Raiwand Road, The University of Lahore
City
Lahore
Postal code
40050
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Nayab John
Street address
Univeristy of Lahore adjacent Chenab river GT road , GujraT ,Punjab ,Pakistan
City
Lahore
Postal code
50700
Phone
+92 42 111 865 865
Fax
Email
drnayab73@gmail.com
Web page address
https://uol.edu.pk/contact-us/
Grant name
Not Applicable
Grant code / Reference number
Not Applicable
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Not Applicable
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nayab John
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1 km Raiwand Road, The University of Lahore
City
Lahore
Province
Punjab
Postal code
50700
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Web page address
https://uol.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nayab John
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1 km Raiwand Road, The University of Lahore
City
Lahore
Province
Punjab
Postal code
50700
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Web page address
https://uol.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Univeristy of Lahore
Full name of responsible person
Nayab John
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1 km Raiwand Road, The University of Lahore
City
Lahore
Province
Punjab
Postal code
50700
Phone
+92 307 6130426
Email
drnayab73@gmail.com
Web page address
https://uol.edu.pk/
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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Not yet decided.
When the data will become available and for how long
not yet applicable
To whom data/document is available
All
Under which criteria data/document could be used
NOT DECIDED YET
From where data/document is obtainable
NOT DECIDED YET
What processes are involved for a request to access data/document