Protocol summary

Study aim
This study aims to evaluate the efficacy of myofascial release and instrument-assisted soft tissue mobilization (IASTM) in reducing pain, stiffness, and range of motion associated with post-surgical elbow stiffness.
Design
Randomized clinical trial, single blinded, parallel group, sample size 24
Settings and conduct
Ahmad Poly Care Clinic, Faisalabad (APCC) , Allied Hospital, Faisalabad (AHF)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male and female , Age 8-40 years, ROM of elbow extension ≥–30 degrees & flexion ≤120 degrees, At least six weeks following surgery, with internal fixation and open reduction. Exclusion Criteria: Participants with any diagnosed auto-immune disorder,Pathological fractures, associated ipsilateral injuries,Injury to both upper limbs, Neuro-vascular disorders, IASTM contraindications (according to the IASTM guidelines), Rheumatic conditions, Circulatory disorders or diabetes.
Intervention groups
Baseline Treatment Both groups received conventional treatments, which included a 5- to 10-minute warm-up with active range-of-motion exercises for the shoulder, elbow, and wrist, gentle passive stretching with 30-second holds for three repetitions, and progressive low-load strengthening activities (for the major upper limb muscle groups). Group A Group A was administered IASTM therapy by means of the “S-shape tool,” an ergonomic stainless-steel instrument with multiple hand grips that reduce operator fatigue. . Group B Group B received myofascial release technique was given. Myofascial release treatment is a kind of continuous, mild massage that helps your myofascial tissues become less painful and tense. Group C Group C received both Instrument-assisted soft tissue mobilization (IASTM) and Myofascial release technique (MFR) to check the effect of both treatments collectively.
Main outcome variables
Pain, Range of motion, Functional disability

General information

Reason for update
Acronym
IASTM , MFR
IRCT registration information
IRCT registration number: IRCT20210528051415N1
Registration date: 2024-07-28, 1403/05/07
Registration timing: retrospective

Last update: 2024-07-28, 1403/05/07
Update count: 0
Registration date
2024-07-28, 1403/05/07
Registrant information
Name
Shaheer Masood
Name of organization / entity
The University of Faisalabad, Faisalabad, Pakistan
Country
Pakistan
Phone
+92 41 8750274
Email address
shaheer_masood@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-03-16, 1402/12/26
Actual recruitment start date
2024-02-17, 1402/11/28
Actual recruitment end date
2024-03-16, 1402/12/26
Trial completion date
2024-05-31, 1403/03/11
Scientific title
Effects of Instrument-Assisted soft tissue mobilization (IASTM) and myofascial release (MFR) in alleviating post-surgical elbow stiffness
Public title
How IASTM and Myofascial Release Alleviate Post-Surgical Elbow Stiffness"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female Age: 8–40 years ROM of elbow extension ≥–30 degrees & flexion ≤120 degrees Least 6-week post-surgery with open reduction and internal fixation Patient with U/L or B/L post-surgical elbow stiffness Willing to participate were included in this study
Exclusion criteria:
Participants with any diagnosed auto-immune disorder Pathological fractures, associated ipsilateral injuries Bilateral upper extremity injuries Neuro-vascular disorders Contraindications for IASTM (as per the IASTM guidelines) Rheumatic conditions Circulatory disorders or diabetes Pregnancy Inability to Follow Rehabilitation Protocols
Age
From 8 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be done with the help of the lottery method. With a lottery method, each member of the population is assigned a number, after which numbers are selected at random
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded: outcomes accessors were kept unaware of which participants received the experimental treatment and which received a comparative intervention. This blinding helps to prevent conscious and unconscious biases that could influence the assessment of study outcome.
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/785

Health conditions studied

1

Description of health condition studied
Post surgical elbow stiffness
ICD-10 code
M25.62
ICD-10 code description
Stiffness of elbow, not elsewhere classified

Primary outcomes

1

Description
Range of motion
Timepoint
Baseline intervention and 3 weeks post intervention
Method of measurement
Goniometer

2

Description
Pain
Timepoint
Baseline intervention and 3 weeks post intervention
Method of measurement
Numeric pain rating scale

Secondary outcomes

1

Description
Functional Disability
Timepoint
Baseline intervention and 3 weeks post intervention
Method of measurement
Liverpool elbow score

Intervention groups

1

Description
Intervention group: Group A received IASTM treatment, which was given by the “S-shape tool”, that is an ergonomically designed stainless steel instrument and offers several different hands holds, eliminating operator fatigue. IASTM has drawn more attention for myofascial restriction based upon James Cyriax soft tissue mobilization.
Category
Rehabilitation

2

Description
Intervention group: Group B received myofascial release technique was given. Myofascial release therapy is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues. Specific techniques include massage, pressure, skin rolling, twisting, and wringing. Applying pressure and stretch in the direction of the tissue restriction, reportedly causes myofascial lengthening and decreased muscle tension.
Category
Rehabilitation

3

Description
Intervention group: Group C received both Instrument-assisted soft tissue mobilization (IASTM) and Myofascial release technique (MFR) in order to check the effect of both treatments collectively.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital, Faisalabad
Full name of responsible person
Dr. Shaheer Masood, PT
Street address
C3XJ+F38, Dr. Tusi Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 303 8926834
Email
shaheer_masood@hotmail.com

2

Recruitment center
Name of recruitment center
Ahmad Poly Care Clinic
Full name of responsible person
Dr. Shaheer Masood, PT
Street address
Satayana Rd, Block B, Peoples Colony 1, Block B People's Colony No 1, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 331 9232210
Email
sherryr386@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Syed Saqlain Babar, PT
Street address
Faisal town, west canal road, Faisalabad, Punjab.
City
Faisalabad
Postal code
38000
Phone
+92 315 6205017
Email
syedsaqlainbabar21@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
The University of Faisalabad
Full name of responsible person
Dr. Sidra Majeed, PT
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal town, west canal road, Faisalabad, Punjab.
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 334 7731241
Email
sidra.majeed@tuf.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Sameer ul Haq, PT
Position
Clinical consultant physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal town, west canal road, Faisalabad, Punjab.
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
The University of Faisalabad
Full name of responsible person
Dr. Saqlain Haider, PT
Position
Clinical Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal town, west canal road, Faisalabad, Punjab.
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 345 7549503
Email
2022-ms-pt-046@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
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
No - There is not 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
Effects of instrument -assisted soft tissue mobilization and myofascial release in alleviating post- surgical elbow stiffness Pain access by NPRS, Range of motion of elbow joint by Goniometer, Functional disability by Liverpool elbow score.
When the data will become available and for how long
30 days after publication.
To whom data/document is available
30 days.
Under which criteria data/document could be used
Access to the data will be facilitated through a specified mechanism, such as secure online portal or data sharing platform. Request for access will be renewed by designated committee or entity responsible for insuring that they made an established criteria and comply with relevant regulations and guidelines. Additional supporting information and document may be provided to assist requesters in understanding the available data and its potential application.
From where data/document is obtainable
The University of Faisalabad, 38000 https:/tuf.edu.pk/0092 41 875 0971-5 Fax +92 41 8750970
What processes are involved for a request to access data/document
To receive the documents or data files, the process typically involves the following steps: 1. Request Initiation: The applicant submits a formal request specifying the documents or data files they need. 2. Verification and Authorization: The organization verifies the request and ensures that the applicant is authorized to access the requested documents or data files. This may involve confirming the identity of the requester and checking their permissions. 3. Processing Time: The processing time varies depending on the complexity of the request, the volume of documents or data files, and any legal or regulatory requirements. It could range from a few hours to several weeks. 4. Document Retrieval or Data Extraction: Once the request is approved, the organization retrieves the documents from their archives or extracts the requested data from their databases. 5. Quality Assurance: Before releasing the documents or data files to the applicant, the organization may conduct quality checks to ensure accuracy and completeness. 6. Delivery: The documents or data files are delivered to the applicant through a secure channel, such as encrypted email, secure file transfer protocols, or a secure online portal. 7. Confirmation of Receipt: The applicant acknowledges receipt of the documents or data files, confirming that they have received the information they requested.
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