Protocol summary

Study aim
To evaluate the effects of floss banding technique and Instrument-assisted soft tissue mobilization on pain, range of motion in Athletes with Achilles tendinopathy
Design
A concealed, randomized, single blinded, sham controlled clinical trials with parallel groups 17 participants in a group total 34 participants. started from July 30, 2024 after ethical committee approval and end in April 2025 following one year
Settings and conduct
Pakistan Sports Board Coaching Center Lahore Saeed Ajmal International Cricket Academy, Naeem Zeshan Shaheed Football Club, Sheefa Badminton Club
Participants/Inclusion and exclusion criteria
Inclusion criteria : Age (18-35y); Gender ( Male and female); If patient feel pain in the achilles tendon; VISA-A score less than 78; Decreased ankle range of motion; Exclusion criteria : Previous Achilles tendon surgery; Pain in any other region (knee, hip); Local infection; If pregnant; Diabetic neuropathy
Intervention groups
Group A recieved 12 sessions of IASTM over a 6-week period in adults with Achilles tendinopathy. Group A received 2 visits treatment per week. IASTM applied for 2 min after 5 min warm up and baseline treatment. Group B received 12 sessions of floss band over a 6 week period in patients with Achilles tendinopathy. Floss band applied for 2 min after warm up and baseline treatment. Patients were assessed before first session, after 6th session and after 12th session.
Main outcome variables
Pain, Range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250525065880N1
Registration date: 2025-05-29, 1404/03/08
Registration timing: retrospective

Last update: 2025-05-29, 1404/03/08
Update count: 0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
Muhammad Hassan Ikhlas
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 334 4788248
Email address
mianhassan896@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2025-12-20, 1404/09/29
Actual recruitment start date
2024-10-15, 1403/07/24
Actual recruitment end date
2025-01-08, 1403/10/19
Trial completion date
2025-04-24, 1404/02/04
Scientific title
Effects of floss banding technique and Instrument-assisted soft tissue mobilization on Pain, Range of motion in athletes with Achilles tendinopathy
Public title
Effects of floss banding technique and Instrument-assisted soft tissue mobilization on Pain, Range of motion in athletes with Achilles tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
If patient feel pain in the achilles tendon, The Victorian Institute of Sport Assessment-Achilles (VISA-A) score less than 78, Decreased ankle range of motion Age between 18y to 35y
Exclusion criteria:
Previous achilles tendon surgery Pain in any other region (knee, hip) Local infection If pregnant Diabetic neuropathy
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 34
Actual sample size reached: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Participants randomly allocated to two groups using sealed envelope method to ensure allocation concealment and biasness reduction. A set of sealed envelop assigned as group A and the other one was group B. Group A was given the Floss band treatment and group B was given the Instrument assisted soft tissue mobilization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were unaware of their allocation. it means that we use envelop method for concealment. we also used sham intervention for participants blinding. we gave a fake treatment of instrument assisted soft tissue mobilization to the FLOSS band group. we did not apply pressure on participants for fake sensation. we did the same procedure to group B of instrument assisted soft tissue mobilization.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research & Ethical Review Committee "Riphah College of Rehabilitation and Allied Health Sciences" R
Street address
25 Raza Saeed Road, Bhabra Block M Gulberg 3, Lahore Pakistan
City
Lahore
Postal code
54660
Approval date
2024-07-30, 1403/05/09
Ethics committee reference number
REC/RCR&AHS/24/0470

Health conditions studied

1

Description of health condition studied
Achilles Tendinopathy
ICD-10 code
M67.00
ICD-10 code description
Short Achilles tendon (acquired), unspecified ankle

Primary outcomes

1

Description
Pain
Timepoint
Before treatment, after sixth visit and after 12th visit
Method of measurement
Numeric Pain Rating Scale , The Victorian Institute of Sport Assessment-Achilles Scale

Secondary outcomes

1

Description
Range of motion
Timepoint
Before treatment starting, After 6th visit and after 12th visit
Method of measurement
Goniometer

Intervention groups

1

Description
In Group A received 12 sessions of floss band over a 6 week period in patients with Achilles tendinopathy. Floss band applied for 2 min after warm up and baseline treatment. Patients were assessed before first session, after 6th session and after 12th session. Warm up with hot pack. Baseline treatment include eccentric exercise 15 repetitions and 3 sets of CALF stretches with 30 seconds hold and then 3sts of strengthening exercise of calf muscles with 15 repetitions per set. Floss band was applied on ankle joint and Achilles tendon with figure 8 warping method. The floss band was with 7 feet length, 1.1mm thickness and 5cm width. Floss band overlapped by 50% to extent possible. passive dorsiflexion and planter flexion inversion and eversion performed after wrapping then remove floss bandtervention group:
Category
Treatment - Other

2

Description
Intervention group: Group B recieved 12 sessions of IASTM over a 6-week period in adults with Achilles tendinopathy. Group A received 2 visits treatment per week. IASTM applied for 2 min after 5 min warm up and baseline treatment. Patients were assessed before first session and after 6th session and at the end of follow-up after 12th session. Warm provided with hot pack. Baseline treatment include eccentric exercise 15 repetitions and 3 sets of CALF stretches with 30 seconds hold and then 3sts of strengthening exercise of calf muscles with 15 repetitions per set. IASTM tool was applied at the angle of 60 degree. IASTM tool was applied parallel to the muscle fibers and tendon
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pakistan sports board Coaching Center Lahore
Full name of responsible person
Mr. Yasir Pirzada
Street address
PSB coaching center ferozpur road
City
Lahore
Postal code
54600
Phone
+92 42 99230382
Email
infopsb@sports.gov.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Shakeel ur rehman
Street address
25 Raza Saeed Road, Bhabra Blpck M Gulberg 3, LahorePunjab
City
Lahore
Postal code
54660
Phone
+92 300 0720887
Email
research.frahslhr@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
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
Riphah international University
Full name of responsible person
Muhammad Hassan Ikhlas
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
PGSHF block D1 house#348 satiana road faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 4788248
Email
mianhassan896@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Muhammad Hassan Ikhlas
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Punjab govt servant housing foundation satiana road faisalabad blockD1 House# 348
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 4788248
Email
drphysio896@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
MUhammad Hassan Ikhlas
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Punjab govt servant housing foundation satiana road faisalabad, Block D1 House# 348
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 4788248
Email
drphysio896@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
No - There is not a plan to make this available
Title and more details about the data/document
Inform consent data collection form, It contain personal information, Contact info
When the data will become available and for how long
Data will be available after 4 weeks of study completion.
To whom data/document is available
For students' Participants' Rsearchers and teachers
Under which criteria data/document could be used
For athletes improvement, For next researches and under Google scholar and Pubmed
From where data/document is obtainable
Google scholar and Pubmed
What processes are involved for a request to access data/document
N/A
Comments
Loading...