study aims to compare the effects of routine physical therapy with and without kinesiotaping for treatment of patients with dequervains tenosynovtis.
Design
single blinded , randomized controlled trial
Settings and conduct
District headquarter hospital Jhang, Punjab, Pakistan.
Participants/Inclusion and exclusion criteria
Patients of both genders are included, age between 20-65years, pre-diagnosed patients who are diagnosed with dequervains syndrome having unilateral symptoms for more than 1 week.
Exclusion criteria:
Patients with Inflamatory or other specific disorders of hand eg Rheumatoid arthritis
fracture
disocation
history of wrist injection
acute trauma
history of surgical intervention
symptomatic biateral radiculopathy
presence of red flag sign related to arm and hand
Intervention groups
Treatment sessions will be conducted thrice weekly (alternative days) and timings of session will be kept same. Conventional treatment will include routine physical therapy protocol (Theraputic ultrasound, TENS, Icing) to be performed on all participants in both groups.
Group A: Only routine physical therapy protocol
Group B: Routine physical therapy protocol and kinesiotaping
Main outcome variables
pain, range of motion and functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220418054572N1
Registration date:2022-05-24, 1401/03/03
Registration timing:retrospective
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Sana Manzoor
Name of organization / entity
University of Lahore, Lahore, Pakistan
Country
Pakistan
Phone
+92 336 3322506
Email address
sanasaim51@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-18, 1400/04/27
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
2021-08-07, 1400/05/16
Actual recruitment end date
2022-03-11, 1400/12/20
Trial completion date
2022-05-05, 1401/02/15
Scientific title
Effects of routine physical therapy with and without kinesiotaping on pain, range of motion and function in patients with dequervain tenosynovitis.
Public title
Effects of routine physical therapy with and without kinesiotaping on pain, range of motion and function in patients with dequervain tenosynovitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders
age between 20-60
Patients diagnosed with Dequervains tenosynovitis having unilateral symptoms more than 1 week
pre-diagnosed patients reffered by orthopedics
finklein's test positive
Exclusion criteria:
patients with history of fracture
patients with inflammatory or other specific disorder of hand such as rheumatoid arthritis
dislocation
surgery
history of wrist injection
acute trauma
symptomatic ilateral radiculopathy
presence of any of red flag related to hand or arm
Age
From 20 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
Investigator
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
in my study Random allocation is done by lottery method. Lottery method is example of Random sampling, in this researcher give each member of population a number and then draw numbers from box randomly to add in each group. in this method each member have equal chance of selection. Total 56 patients of both genders of age between 20-60 years are included. Patients are randomly allocated by lottery method to Group A ( only physical therapy treatment which include theraputic ultrasound ,tens, icing and ROMS ) and Group B includes ( physical therapy treatment i-e theraputic ultrasound, Tens, icing and RoMS and kinesiotaping too). Patients do not know in which group they are allocated.
Blinding (investigator's opinion)
Single blinded
Blinding description
study will be single binded , assessor will be kept blind. Assesor does not know that which subject is included in which group. Asseser does not know group A or group B is recieving which type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Lahore
Street address
1 km, defence road Bhobtian chowk, Raiwind road Lahore.IR
City
Lahore
Postal code
42000
Approval date
2021-07-08, 1400/04/17
Ethics committee reference number
IRB-UOL-FAHS/1080/2021
Health conditions studied
1
Description of health condition studied
Dequervain's tenosynovitis is a condition which involves tendon entrapmentaffecting the first dorsal compartment of wrist. In ths condition thickening of tendon sheath around abductor pollicis longus and extensor pollicis brevis, which leads to irritation of muscles, causing pain and swelling over the radial side of wrist in patients alon with an increased difficulty in gripping obejcts.
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
Pain
Timepoint
1st day before treatment, at 7th session and on day of 15th session(after last treatment session)
Method of measurement
pain is measured by visual analogue scale. 0-100 points are given on scale. scoring for that scale is as given below: No pain (0 – 4 mm)Mild pain (5– 44mm)Moderate pain (45–74 mm)Severe pain (75–100 mm). Patients are asked to fill this according to their pain , if they have no pain then 0 or 0-4mm, if they have mild pain then fill 5-44mm ,if have moderate pain (45-74mm) and if they have severe pain then fill 75-100mm.
2
Description
functional disability
Timepoint
1st day before treatment, at 7th session and on day of 15th session(after last treatment session)
Method of measurement
Functional disability is measured by Quick Dash score. QuickDASH-9 SCORE = [(sum of final score) x 1.1] x 5/2, a missing response is added as the average of the remaining. score between 0-25 no disability, 26-50 mild disability, 51-75 moderate disability, 76-100 severe disability. a scale score, ranging from 0 (no disability) to 100 (most severe disability), can be calculated.
3
Description
Range of motion
Timepoint
1st day before treatment, at 7th session and on day of 15th session(after last treatment session)
Method of measurement
Goniometer . Goniometer is placed on hand nd ask patient to extend the thumb
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine physical therapy (Theraputic Ultrasound, TENS, icing) Patient in this study group will get 25 minutes session, thrice weekly for 4 weeks. Therapeutic ultrasound will be performed for 10 minutes, icing for 5 minutes, TENS will be applied for 5 minutes and general ROMS of adjacent joints.
Category
Treatment - Other
2
Description
Intervention group: routine physical therapy with addition of kinesiotaping. Patients in this study group will get 25 minutes session, thrice weekly for 4 weeks. Kinesiotape will be applied to the subjects 3 times weekly (alternative days) in addition to routine physical therapy. We will use three types of taping I pieces of Kinesio tape, First of all, we will curve all borders of tapes to prevent early separation. The first strip will be used to unload from APL and EPB tendons. The tape will be placed on the insertion of EPB, the base of the thumb, and was stretched by approximately 70% over the original length applied along the radial aspect of the wrist and up onto the extensor surface, ending at the mid-forearm (origin of APL). The second and the third type have correction roles. The second one is named “function correcting” tape, with the wrist extended, putting the end of the tape at the dorsum of the hand and another end at the distal forearm, 1 inch upper than styloid. Then by flexing the wrist, the tape will be fixed. The third tape which is called “space correcting”, originates from the volar side of distal of radius and stretched obliquely to the dorsum of the hand with a lighter tension which is shown at 50%. Then we will fix them with a light massage and suggested not to use water for 6 hours in this area. All the taping will be applied by the physiotherapist carefully. These procedures of taping will be repeated for three times weekly.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
District Headquarter Hospital Jhang
Full name of responsible person
Sana Manzoor
Street address
Rehmat street rana colony, House no p441 G-56 gojra road jhang, punjab Pakistan