The efficacy of IASTM and deep transverse friction massage on Achilles tendon for patients of Achilles Tendinopathy on pain and disability was not evaluated and it is a less explored area. So, this research study will be carried out to evaluate whether instrument assisted STM or without instrument STM have same effect or not.
Design
Randomized clinical trial, Single blinded, Parallel groups, 40 sample size
Settings and conduct
• Pro Health Rehab & Medical Center, Faisalabad
• In Motion Physiotherapy and Rehabilitation Clinic, Faisalabad
• Al-Haq Physio & Rehabilitation Center, Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• 18 to 40 years of age
• Clinically diagnosed with AT by a clinician
• Pain that is localized 2-7 cm from the tendon's distal insertion
• Patient with U/L or B/L AT
• Male and female
• Having pain greater than 3 on NPRS
• Positive Royal London hospital test
• Positive Arc sign
• Willing to participate will be included into study
Exclusion Criteria
• Past history of ankle fracture that affect joint
• Having pain 3 or less than 3 on NPRS
• Insertional tendinopathy
• Rheumatic conditions
• Diabetes or circulatory issues
• Achilles tendon injuries other than AT
• Positive Thompson’s test
• Patient with age less than 18 years or above than 40 years
• Participants with any diagnosed auto-immune disorder
• Having co-morbidities such as neoplasm
Intervention groups
Treatment Plan
Group A
For group A Instrument assisted soft tissue mobilization (IASTM) was given 3-5 min with 10 mints of warm up session using ultrasound as baseline treatment.
Group B
For group B transverse deep friction massage was given for time 10 min. 10 mints of warm up session using ultrasound as baseline treatment.
Main outcome variables
• Pain
• Functional Disability
General information
Reason for update
Acronym
ACHILLES TENDINOPATHY
IRCT registration information
IRCT registration number:IRCT20240429061592N1
Registration date:2024-05-10, 1403/02/21
Registration timing:retrospective
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Sameer Ul Haq
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 342 0817195
Email address
sameerulhaq076@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
2024-02-17, 1402/11/28
Actual recruitment end date
2024-04-19, 1403/01/31
Trial completion date
2024-04-19, 1403/01/31
Scientific title
COMPARATIVE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION AND DEEP TRANSVERSE FRICTION MASSAGE ON SUBJECTS WITH ACHILLES TENDINOPATHY
Public title
COMPARATIVE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION AND DEEP TRANSVERSE FRICTION MASSAGE ON SUBJECTS WITH ACHILLES TENDINOPATHY
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 40 years of age
Clinically diagnosed with AT by a clinician
Pain that is localized 2-7 cm from the tendon's distal insertion
Patient with U/L or B/L AT
Having pain greater than 3 on NPRS
Positive Royal London hospital test
Positive Arc sign
Willing to participate will be included into study
Exclusion criteria:
Past history of ankle fracture that affect joint
Having pain 3 or less than 3 on NPRS
Insertional tendinopathy
Rheumatic conditions
Diabetes or circulatory issues
Achilles tendon injuries other than AT
Positive Thompson’s test
Patient with age less than 18 years or above than 40 years
Participants with any diagnosed auto-immune disorder
Having co-morbidities such as neoplasm
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly allocated in to groups by means of lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over.
Placebo
Not used
Assignment
Parallel
Other design features
Purposive sampling technique was used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of The University of Faisalabad
Street address
University Avenue, Faisal Town 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/777
Health conditions studied
1
Description of health condition studied
Achilles Tendinopathy
ICD-10 code
M76.6
ICD-10 code description
Achilles Tendinopathy
Primary outcomes
1
Description
Pain
Timepoint
Before Intervention and at the end of 3rd week
Method of measurement
NPRS
Secondary outcomes
1
Description
Functional Disability
Timepoint
Before Intervention and after 3rd week
Method of measurement
VISA-A Achilles Questionnaire
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
• Pro Health Rehab & Medical Center, Faisalabad
Full name of responsible person
Dr. Zain Ali Bal; PT
Street address
P-346 Amin Town, C-Block Kashmir Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 306 6706867
Email
sameerulhaq076@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
• Al-Haq Physio & Rehabilitation Center, Faisalabad
Full name of responsible person
Dr. Sameer Ul Haq; PT
Street address
Chak No195 R.B, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 342 0817195
Email
sameerulhaq076@gmail.com
3
Recruitment center
Name of recruitment center
n Motion Physiotherapy and Rehabilitation Clinic, Faisalabad
Full name of responsible person
Dr. Hanan Abdullah; PT
Street address
513-F Gulistan Colony no. 1, Raja Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 310 7436476
Email
sameerulhaq076@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
THE UNIVERSITY OF FAISALABAD
Full name of responsible person
Syed Saqlain Babar
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 315 6205017
Email
syedsaqlain264@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
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
Al Haq Physio & Rehablition Center
Full name of responsible person
Sameer Ul Haq
Position
CEO
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Chak no 195 r.b Jandanwala, Millat Road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 342 0817195
Email
sameerulhaq076@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Al Haq Physio & Rehabilitation Center
Full name of responsible person
Sameer Ul Haq
Position
CEO
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Chak no 195 r.b Jandanwala, Millat Road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 342 0817195
Email
sameerulhaq076@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Al Haq Physio & Rehabilitation Center
Full name of responsible person
Sameer Ul Haq
Position
CEO
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Chak no 195 r.b Jandanwala, Millat Road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 342 0817195
Email
sameerulhaq076@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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
All Collected Deidentified
When the data will become available and for how long
starting in January 2025
To whom data/document is available
Everyone
Under which criteria data/document could be used
Everyone who required for academic or clinical purpose
From where data/document is obtainable
By contacting on Gmail
What processes are involved for a request to access data/document