Protocol summary

Study aim
1) To determine the effects of Active Release and Post isometric Relaxation Techniques on pain and functional performance in patients with chronic lateral epicondylitis. 2) To determine the effects of Active Release and Post isometric Relaxation Techniques on grip strength in patients with chronic lateral epicondylitis.
Design
1. Single blinded Randomized clinical trial. 2. Outcomes Assessor (single blinded). 3. Clinical diagnosed with lateral epicondylitis by orthopedic surgeon.
Settings and conduct
Settings: Sialkot medical complex hospital. Conduct: OPD of related hospital (physiotherapy department). Single blinded: A clinical trial in which outcomes assessor is blinded. An expert medical officer is working as outcomes assessor. Assessor has taken a Pre and Post treatment evaluation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Subject with unilateral epicondylitis. • Age group between 25-45 years with pain of atleast 6 weeks. • Both genders (males and females). Exclusion criteria: • History of cervical radiculopathy. • History of peripheral nerve involvement. • History of previous surgery of elbow.
Intervention groups
Techniques apply containing active release technique with conventional treatment (pulse ultrasound for 5 minutes) for lateral epicondylitis and Post isometric relaxation (METS) with conventional protocol for lateral epicondylitis patient.
Main outcome variables
Outcome variables: Pain by NPRS tool. Grip strength by Dynamometer. Functional performance by PRTEE scale

General information

Reason for update
Acronym
LE (Lateral Epicondylitis)
IRCT registration information
IRCT registration number: IRCT20200502047274N1
Registration date: 2020-05-18, 1399/02/29
Registration timing: registered_while_recruiting

Last update: 2020-05-18, 1399/02/29
Update count: 0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Ans Hanif
Name of organization / entity
Country
Pakistan
Phone
+92 52 3312562
Email address
anshanif01@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-26, 1398/07/04
Expected recruitment end date
2020-08-01, 1399/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Active release and Post isometric relaxation techniques on Functional performance in Patients with chronic lateral epicondylitis.
Public title
Compare Strengthening and stretching exercises to improve functional activities in right sides elbow pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subject with unilateral epicondylitis. Age group between 25-45 years with pain of atleast 6 weeks. Both genders (males and females). Subject with pain over lateral epicondyle upon palpation, resisted wrist extension or 2nd or 3rd finger extension. Subject lies on 6-10 point in NPRS. Subject with positive Mill’s and Cozen’s test.
Exclusion criteria:
History of cervical radiculopathy. History of peripheral nerve involvement. History of previous surgery of elbow. History of previous physiotherapy treatment and any steroid injection during last 6 months.
Age
From 25 years old to 40 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
All subjects will be allocated to group A and B by simple randomization method using random number table. Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
A clinical trial in which outcomes assessor is blinded. An expert medical officer is working as outcomes assessor. Assessor has taken a Pre and Post treatment evaluation.
Placebo
Not used
Assignment
Parallel
Other design features
Randomized clinical trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
"Ethics committees of Riphah International university Islamabad"
Street address
l-14, near Hajj Complex, Capital Territory, Islamabad
City
Islamabad
Postal code
46000
Approval date
2019-11-30, 1398/09/09
Ethics committee reference number
005896

Health conditions studied

1

Description of health condition studied
Lateral Epicondylitis
ICD-10 code
M77.10
ICD-10 code description
Lateral epicondylitis, unspecified elbow

Primary outcomes

1

Description
Grip Strength
Timepoint
6 weeks before Intervention
Method of measurement
Hand held Dynamometer

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group 1:"Active release technique with conservative protocol ( pulse ultrasound 5minutes) for lateral epicondylitis patient. "Interventional group 2:" Post isometric relaxation techniques with conservative protocol (pulse ultrasound 5 minutes) for lateral epicondylitis patient.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sialkot Medical Complex, Sialkot
Full name of responsible person
Ans Hanif
Street address
No 1, Commissioner Road, Sialkot
City
Sialkot
Postal code
51310
Phone
+92 52 3312562
Email
anshanif01@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Shakil ur rehman
Street address
28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore, Pakistan
City
Lahore
Postal code
54000
Phone
Email
Admissions.lahore@riphah.edu.pk
Grant name
Shakil Ur Rehman
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
" Investigator initiated"
Proportion provided by this source
1
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
Sialkot Medical Complex, Sialkot
Full name of responsible person
Salman Iftkhar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.1, Commissioner road, Sialkot
City
Sialkot
Province
Punjab
Postal code
51310
Phone
+92 52 3312562
Email
Salman01@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sialkot Medical Complex, Sialkot
Full name of responsible person
Salman Iftkhar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.1, Commissioner road, Sialkot
City
Sialkot
Province
Punjab
Postal code
51310
Phone
+92 52 3312562
Email
salman01@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sialkot Medical Complex, Sialkot
Full name of responsible person
Ans Hanif
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
54/282 ghazi officer colony ghazi pur sialkot cantt
City
Sialkot
Province
Punjab
Postal code
51310
Phone
+92 52 3312562
Email
Anshanif01@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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