To Compare the effects of Mobilization with movement and oscillatory mobilization on pain, range of motion and disability among patients with De Quervain's tendinopathy
Design
The design of this study is Randomized, parallel Clinical Trial. Randomization is done by lottery method. In this method, the researcher gives each participant of the trial a number. Researchers draw numbers from the box randomly to allocate participants in two groups
Settings and conduct
The eligible participants for physiotherapy referring to the Arif Memorial Hospital in Lahore city during the study period will be enrolled in the trial and will be randomly assigned to the intervention groups through the randomization. This trial will be single-blinded so that outcome accessor will not be aware of the allocation of participants.
Participants/Inclusion and exclusion criteria
inclusion criteria: The participants with Age 20 to 45 , who experienced pain at the wrist, over the extensor pollicis brevis and abductor pollicis longus tendons were considered positive for tenosynovitis are included and they should have positive Finkelstein test as it is used to define De Quervain.
Exclusion Criteria: The participant with Radial-side wrist pain due to carpometacarpal arthritis and Fracture of the wrist, wrist operation and whose hand is immobilized are excluded.
Intervention groups
Intervention Group A: Baseline treatment of ultrasound in continuous mode with frequency of 3 MHz and intensity of 0.1 to 1.5 W/cm2 and then Manual therapy (mobilization with movement) will be performed 3 sessions per week for 2 weeks.
Intervention Group B: Baseline treatment of ultrasound as group A and then Manual therapy (oscillatory Mobilization) will be performed 3 sessions per week for 2 weeks.
Main outcome variables
Pain,
Range of motion,
Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220604055072N2
Registration date:2023-06-28, 1402/04/07
Registration timing:prospective
Last update:2023-06-28, 1402/04/07
Update count:0
Registration date
2023-06-28, 1402/04/07
Registrant information
Name
Aleena Waheed
Name of organization / entity
Rashid Latif Medical College
Country
Pakistan
Phone
+92 321 4883868
Email address
alwaheed28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-20, 1402/04/29
Expected recruitment end date
2023-10-20, 1402/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of Mobilization with movement and oscillatory mobilization on De Quervain's tendinopathy
Public title
Mobilization with movement versus oscillatory mobilization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 45
The participants who experienced pain at the wrist, over the extensor pollicis brevis and abductor pollicis longus tendons were considered positive for tenosynovitis.
Finkelstein test were used to define De Quervain
Exclusion criteria:
Radial-side wrist pain due to carpometacarpal arthritis
Fracture of the wrist and/or operation
Immobilization
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by lottery method. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 35 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 28 cards were taken out, 14 participants in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding is achieved by concealment in which the treatment allocation for each patient from the accessor. The accessor will only assess variable at pre and post intervention. This is done to avoid biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of Rashid Latif Medical College
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Approval date
2022-10-05, 1401/07/13
Ethics committee reference number
IRB/2022/054
Health conditions studied
1
Description of health condition studied
De Quervain tendinopathy
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
Pain
Timepoint
Pre-intervention and 2 weeks Post-intervention
Method of measurement
Numeric Pain Rating Scale
2
Description
Range of Motion
Timepoint
Pre-intervention and 2 weeks Post-intervention
Method of measurement
Goniometer
3
Description
Disability
Timepoint
Pre-intervention and 2 weeks Post-intervention
Method of measurement
Patient related Rated wrist Evaluation Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group A: Baseline treatment of ultrasound in continuous mode with frequency of 3 MHz and intensity of 0.1 to 1.5 W/cm2 and then Manual therapy (mobilization with movement) will be performed per session. 3 sessions per week and treatment will be followed for 2 weeks . For manual therapy the patient position will be in sitting with elbow flexed and hand resting on the table. Then Mobilization with movement technique involved a lateral glide of the proximal carpal row moving on the radio-ulnar joint while the patient performed active thumb flexion. The mobilization with movement technique on carpometacarpal joint was utilized to improve abductor pollicis longus and extensor pollicis brevis soft tissue mobility. This will be repeated for 3 times per session.
Category
Treatment - Other
2
Description
Comparative Intervention Group B: Baseline treatment of ultrasound in continuous mode with frequency of 3 MHz and intensity of 0.1 to 1.5 W/cm2 and then Manual therapy (oscillatory Mobilization) will be performed per session. 3 sessions per week and treatment will be followed for 2 weeks For manual therapy the patient position will be in sitting with elbow flexed and hand resting on the table. Firstly Grade I and II oscillatory mobilization then III–IV posterior to anterior oscillations were performed at end range to the first carpometacarpal joint to facilitate mobility. This will be repeated for 3 times per session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif Memorial Teaching Hospital
Full name of responsible person
Waqas Qadir
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 317 4556495
Email
M.faruki97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Aleena Waheed
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 321 4883868
Email
alwaheed28@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical College
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
Rashid Latif Medical College
Full name of responsible person
Waqas Qadir
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 317 4556495
Email
M.faruki97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Aleena Waheed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 321 4883868
Email
alwaheed28@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Aleena Waheed
Position
Punjab
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 321 4883868
Email
alwaheed28@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
Undecided - It is not yet known if there will be a plan to make this available
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
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