To evaluate the effects of the Active Release Technique and Positional Release Technique in female students with tightened calf muscles.
Design
Randomized controlled trial design
.
Settings and conduct
The University of Faisalabad
Government College University Faisalabad.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Age 20-30 years
• Reduced ROM (ankle dorsiflexion)
• Height of heel: 2” and above
• Through flat palpation, one hypersensitive sore nodule within a perceptible tense band in the leg muscle
Exclusion criteria
• Lower limb musculoskeletal injury or surgery
• Acute Cardio-Respiratory or Neurological disease
• Medical or surgical complications
• Fibromyalgia syndrome
• Congenital deformity of the foot and ankle
• Lower limb fracture
• Diabetic neuropathy
• Peripheral vascular disease
Intervention groups
Subjects were divided into two groups by convenient sampling technique using the lottery method. Pre-treatment readings were taken from each subject for pain using NPRS, ROM (dorsiflexion and plantarflexion), and respectively. Treatment was given for a total of four weeks. 3 times each week for both groups. Ultrasound was used as the baseline treatment for both groups. Both groups received conventional Physiotherapy treatment which included stretching of both gastrocnemius and soleus muscles. Treatment Group A performed Active Release Therapy and Group B performed Positional Release Therapy
Comparative Effects Of Active Release Technique And Positional Release Therapy In Female Students With Tightened Calf Muscles.
Public title
Active Release Technique And Positional Release Therapy For Tightened Calf Muscles.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects wearing high heels and willing to participate
Age 20-30 years
Reduced ROM (ankle dorsiflexion)
NPRS showing more than 3
Heels wearing duration: minimum 1 year
Wearing heels at least 5 times every week for 5 hours per day
Height of heel: 2” and above
Through flat palpation, one hypersensitive sore nodule within a perceptible tense band in the leg muscle
Exclusion criteria:
Lower limb musculoskeletal injury or surgery
Acute Cardio-Respiratory or Neurological disease
Medical or surgical complications
Fibromyalgia syndrome
Congenital deformity of the foot and ankle
Lower limb fracture
Diabetic neuropathy
Peripheral vascular disease
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method was used.
Individual randomization was assigned.
Table of random number of participants were generated.
Sealed envelopes were used in randomization.
The random sequence is typically built using algorithms that generate random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of their assigned groups (treatment/control) due to identical presentation of interventions.
In investigator-initiated trials, the PI is not involved in treatment allocation discussions with participants.
Care providers are blinded to participants' treatments, ensuring unbiased care delivery.
Those collecting data are uninformed about treatment allocation, maintaining objective data gathering.
Data Safety and Monitoring Board's access to treatment information is limited, focusing on safety.
Writers use anonymized data, avoiding bias in result interpretation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institutional review committee board of ethics The university of Faisalabad
Street address
Sheikhupura Road Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-02-03, 1401/11/14
Ethics committee reference number
TUF/Addl Reg/SB/352
Health conditions studied
1
Description of health condition studied
Tightness Of Calf Muscles
ICD-10 code
M62.838
ICD-10 code description
Other muscle spasm
Primary outcomes
1
Description
Pain
Timepoint
before intervention, 2nd week and 4th week after intervention
Method of measurement
Numerical Pain Rating Scale
Secondary outcomes
1
Description
Ankle Range of Motion
Timepoint
before intervention, 2nd week and 4th week after intervention
Method of measurement
goniometer
2
Description
Cadence
Timepoint
before intervention, 2nd week and 4th week after intervention
Method of measurement
stop watch
Intervention groups
1
Description
Intervention Group 1: The group comprised of participants who received the experimental intervention under investigation. The intervention is designed to briefly describe the nature and purpose of the intervention. Participants in this group will be exposed to details of the intervention, such as treatment, therapy, medication, or any specific procedures. The objective of this intervention is explained the intended outcomes or goals.
Category
Treatment - Other
2
Description
Intervention group 2: The group comprised of participants who received the experimental intervention under investigation. The intervention is designed to briefly describe the nature and purpose of the intervention. Participants in this group will be exposed to details of the intervention, such as treatment, therapy, medication, or any specific procedures. The objective of this intervention is explained the intended outcomes or goals.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The University Of Faisalabad
Full name of responsible person
Dr. Mariam Mehmood
Street address
Sargodha Road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 301 4223896
Email
mariam.mehmood@tuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sibgah Maqsood
Street address
Gulshan-e-Hayat Town, ABC road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 321 7838237
Email
Sibgahmaqsood547@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
Dr. Mariam Mehmood
Position
Clinical Coordinator
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
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
Sibgah Maqsood
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Gulshan-e-Hayat, ABC road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 7838237
Email
sibgahmaqsood547@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Sibgah Maqsood
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Gulshan-e-Hayat, ABC road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 7838237
Email
sibgahmaqsood547@gmail.com
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD collected for the primary and secondary outcome both measure
When the data will become available and for how long
starting in January 2025
To whom data/document is available
Academicians
Under which criteria data/document could be used
For Research purpose only
From where data/document is obtainable
sibgahmaqsood547@gmail.com
What processes are involved for a request to access data/document
if any researcher share their ethical approval letter and summary of the ongoing research.