To evaluate the effectiveness of the primal reflex release technique on calf tightness
Design
Design of the study was randomized clinical trial, sample size was 32, parallel groups, single blind
Settings and conduct
Madina teaching Hospital, Faisalabad and The University of Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Adult Age 20 to 30 years
Both gender (male, female)
Prolong standing for more than six hours from more than two months.
Reduced ROM (ankle dorsiflexion<15).
Tender nodules or tender points in calf muscles on deep palpation.
NPRS showing more than 3(3-10).
Exclusion Criteria:
Lower limb surgery (six months).
Medical or surgical complication e.g infection, necrosis, ulcer.
Fibromyalgia.
Congenital foot and ankle deformity e.g club foot, cleft foot, pes cavus.
Lower limb fracture.
Deep vein thrombosis both acute and chronic.
Diabetic neuropathy.
Intervention groups
Two interventional groups numbered as group A and group B in which group A received primal reflex release technique and group B received positional release technique while the baseline treatment was hot pack.
Main outcome variables
Pain, ROM, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240721062499N1
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
Sana Talib
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8868326
Email address
2022-ms-pt-023@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-29, 1402/12/10
Expected recruitment end date
2024-05-10, 1403/02/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of primal reflex release technique versus positional release technique on tightened calf muscles
Public title
Primal reflex release technique for calf tightness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult Age 20 to 30 years
Both gender (Male, Female)
Prolong standing for more than six hours from more than two months.
Reduced ROM (ankle dorsiflexion<15).
Tender nodules or tender points in calf muscles on deep palpation.
NPRS showing more than 3(3-10).
Exclusion criteria:
Lower limb surgery (six months).
Medical or surgical complication e.g infection, necrosis, ulcer.
Fibromyalgia.
Congenital foot and ankle deformity e.g club foot, cleft foot, pes cavus.
Lower limb fracture.
Deep vein thrombosis both acute and chronic.
Diabetic neuropathy.
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization clinical trial was conducted by using stratified randomization.
Unit of randomization were individuals. The tools used in randomization were random numbers. Random sequence was done by selecting the individuals one by one as they met the criteria of inclusion. Allocation concealment was carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were blinded in the study. The researcher did not inform the participant that in which intervention group they have been added.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics / technical committee for The University of Faisalabad
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2024-01-05, 1402/10/15
Ethics committee reference number
TUF/Addl Reg/SB/769
Health conditions studied
1
Description of health condition studied
Calf tightness
ICD-10 code
M79.606
ICD-10 code description
Pain in leg, unspecified
Primary outcomes
1
Description
pain
Timepoint
Before intervention and after 4 weeks after intervention
Method of measurement
NPRS
Secondary outcomes
1
Description
Range of motion
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Goniometer
Intervention groups
1
Description
Intervention group 1 or group A was provided with primal reflex release technique and hot pack as baseline treatment. Two sessions were done during a week and duration of each session was of 15 minutes. In a single session 3 sets of the technique was given with each set of 10-15 seconds and hot pack for 10 minutes. The procedure of the technique is as follows; With knee flexed at 90 degrees ask patient to dorsiflex ankle while keeping toes flexed. Now apply strokes on anterior tibialis tendon while patient holds ankle in dorsiflexion against resistance.
Category
Treatment - Other
2
Description
In intervention group 2 or group B, participants received positional release technique (3 sets in which each set was of 90 seconds) for calf tightness and hot pack (10 minutes) as baseline treatment. Total time for each session was 15 minutes. For gastrocnemius the subject in prone position and ankle in plantar flexion and knee in 90-degree flexion. For 90 seconds, the therapist applies intense pressure to palpable taut band for 3 times.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Faisalabad, Madina teaching Hospital
Full name of responsible person
Rubeena Zulfiqar
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
studentaffairshsw@tuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Rubeena Zulfiqar
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
studentaffairshsw@tuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
The University of Faisalabad
Full name of responsible person
Rubeena Zulfiqar
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Email
asst.prof.rehab.446@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Rubeena Zulfiqar
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Email
asst.prof.rehab.446@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Rubeena Zulfiqar
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Faisal Town, West Canal Road, Faisalabad, Punjab
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Email
asst.prof.rehab.446@tuf.edu.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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
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
Comparative effects of primal reflex release technique versus positional release technique on tightened calf muscles / results for primary outcome measures
When the data will become available and for how long
starting of October 2024
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
medical students, teachers
From where data/document is obtainable
2022-ms-pt-023@tuf.edu.pk
What processes are involved for a request to access data/document