Protocol summary

Study aim
To evaluate the effect of Kinesiology Taping and Mulligan’s Pain Release Phenomena in reducing pain in patient having De Quervain’s Tenosynovitis. To determine the effect of Mulligan’s Pain Release Phenomena and Kinesiology Taping for improving the symptoms of De Quervain’s Tenosynovitis without any complication.
Design
Single blinded Quantitative study , following the research design of randomized clinical trial .Randomization is through Lottery Method.
Settings and conduct
Subjects with De Quervain's Tenosynovitis will be taken from these 3 hospital setting Nishtar Hospital Multan, Combined Military Hospital (CMH) Multan and Shahbaz Sharif DHQ Hospital Multan. Blinding: participants will be blinded they will not be aware whether they are Treatment or Active Control Group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Participants having mild to moderate pain 3 to 6 according to Numeric Pain Rating Scale, Difficulty moving the thumb (with Positive Finkelstein test). Exclusion criteria: Participants with following conditions -Recent fracture of wrist. -Fixed contracture of wrist.-Patient with open wounds.- Perceptive and cognitive disorders.
Intervention groups
Group A: 1-Therapeutic Ultrasound (10 min Baseline) Treatment. 2-Kinesiology Taping. Group B: 1-Therapeutic Ultrasound (10 min Baseline) Treatment. 2-Mulligan's Pain Release Phenomena.
Main outcome variables
Numeric Pain Rating Scale, Goniometer, Patient Rated Wrist Evaluation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220401054386N1
Registration date: 2022-05-28, 1401/03/07
Registration timing: registered_while_recruiting

Last update: 2022-05-28, 1401/03/07
Update count: 0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Asma Sattar
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 316 1614659
Email address
dpt-fa11-021@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-29, 1401/02/09
Expected recruitment end date
2022-05-30, 1401/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effect of Kinesiology Taping and Mulligan’s Pain Release Phenomena in patient having De Quervain’s Tenosynovitis: A Randomized Clinical Trial.
Public title
Comparison of Kinesiology Taping and Mulligan's Pain Release Phenomena in patients having De Quervain's Tenosynovitis symptoms.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who are willing to participate. Age 20 - 40 years. Male and Female Patients. Patient having mild to moderate pain 3 to 6 according to NPR. Difficulty moving the thumb (with Positive Finkelstein test).
Exclusion criteria:
Patient with recent fracture of wrist. Patient with fixed contracture of wrist. Patient with open wounds. Patient having perceptive and cognitive disorders. Patient who are not willing to participate.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
30 subjects will be taken and divided into 2 groups by simple randomization. In a random sample, each individual unit has an equal chance of getting selected. Similarly, in a lottery method, each individual unit is selected at random from the population and thereby has an equal opportunity of getting selected. Randomization is done by lottery method, sealed envelop will made upon which allocation of participants in both groups can be possible without biasness. Lottery method always gives a random sample's outcome. A researcher randomly picks numbers, with each number corresponding to a subject or item, in order to create the sample. To create a sample this way, the researcher must ensure that the numbers are well mixed before selecting the sample population. Concealed allocation will be carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants of both groups will be unaware weather they are in active control or treatment group after the informed consent has been taken from them. Participants of both group will receive the same baseline treatment that is Ultrasound. After that Physiotherapist will apply Kinesiology Taping to one group and Mulligan Pain Release Phenomena to other group of which the participants will be unaware.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of The University of Faisalabad.
Street address
4-km, Sargodha Road, University Town, Faisalabad.
City
Faisalabad
Postal code
38000
Approval date
2022-04-07, 1401/01/18
Ethics committee reference number
TUF/DR/MSPP/322

Health conditions studied

1

Description of health condition studied
De Quervain’s Tenosynovitis most commonly occurring cause of wrist and hand pain, commonly tendonitis of wrist.De Quervain’s Tenosynovitis is a condition commonly occurring due to pathology of tendon of abductor pollicis longus and extensor pollicis brevis. De Qurvain’s Tenosynovitis occur with symptoms as the pain over radial styloid that increases with movement of thumb with the tenderness experienced over the first dorsal compartment. De Quervain’s Tenosynovitis may be occurred either due to any acute and sudden trauma or may be more often as a result of repetitive microtrauma.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain in thumb movements will be primary outcome variable.
Timepoint
Pain level will measured before applying the intervention and then after 6 weeks after the completion of intervention
Method of measurement
Numeric Pain Rating Scale and Patient Rated Wrist Evaluation will be used.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A (Kinesiology Taping Group) receive baseline treatment include Therapeutic Ultrasound for 10 minutes, then Kinesiology Taping is applied for 6 weeks. Patient will received Kinesiology Taping 4 times per week .
Category
Rehabilitation

2

Description
Intervention group: B (Mulligan's Pain Release Phenomena) all subjects in this will receive baseline treatment include Therapeutic Ultrasound 10 minutes, then Mulligan’s Pain Release Phenomena. PRP will apply for 6 weeks .
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Nishtar Hospital Multan
Full name of responsible person
Medical Superintendent Nishtar Hospital Multan
Street address
Nishtar Rd, Justice Hamid Colony, Multan,
City
Multan
Postal code
60000
Phone
+92 61 9330153
Email
webmaster@nmch.edu.pk
Web page address

2

Recruitment center
Name of recruitment center
Combined Military Hospital (CMH) Multan
Full name of responsible person
Medical Superintendent Combined Military Hospital (CMH) Multan
Street address
Ghaus ul Azam Road، near Naseem Hayat Rd، Pia Colony, Multan
City
Multan
Postal code
60000
Phone
+92 61 4504784
Email
cimspakistan@gmail.com
Web page address

3

Recruitment center
Name of recruitment center
Shahbaz Sharif DHQ Hospital Multan
Full name of responsible person
Medical Superintendent Shahbaz Sharif DHQ Hospital Multan
Street address
Abdali road near Ghanta Ghar Chowk Multan.
City
Multan
Postal code
60000
Phone
+92 61 4588580
Email
tabish_mul@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Sidra Majeed; PT
Street address
4-km Sargodha road, University Town, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8750971
Email
sidra.majeed@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
Dr. Sidra Majeed ; PT
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
4km-Sargodha Road, University Town , Faisalabad
City
Faisalabd
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
Asma Sattar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 04, F block Nayab City Multan
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 316 1614659
Email
dpt-fa11-021@tuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Asma Sattar
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house 04,block F, nayab city , Multan
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 316 1614659
Email
dpt-fa11-021@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
Undecided - It is not yet known if there will be 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 participants data set for the outcomes measure.
When the data will become available and for how long
4 month after publication
To whom data/document is available
People working in the academic institutions .
Under which criteria data/document could be used
IPD and any additional supporting documents will be provided for the research on the similar topic and can be obtained by asking through contact person mentioned below.
From where data/document is obtainable
Contact Person : Asma Sattar. Contact number:03161614659 Email: asmatalat23@yahoo.com
What processes are involved for a request to access data/document
Data file will be provided after talking to contact person as mentioned in the above slot.
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