To find out the effects of hydrotherapy versus land based exercises on pain and grip strength in osteoarthritis of hand
Design
Parallel study groups, 68 sample size, phase 2, randomized, single center
Settings and conduct
Study setting is Aziz Bhatti Shaheed Hospital Gujrat, Pakistan. Participant will be allocated to the assigned treatment group after informed consent. Participant will not be aware of any other treatment given to other participant of same condition. Outcome assessor and data analyzer will be unaware of the treatment given to the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: subjects between the age of 40-60 years old; criteria based on American College of Rheumatology.
Exclusion criteria: patient with co morbidities; traumatic injuries of hand; hand surgery past 6 weeks; steroid injections past 2 weeks; cognitive or mental dysfunction.
Intervention groups
Group A: The participants will be treated with land based exercises and also treated with 5 minutes heat therapy as baseline treatment.
Group B: The participants will be treated hydrotherapy based exercises and will be given 5 minutes heat therapy as baseline treatment
Main outcome variables
Pain and Grip strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200511047403N1
Registration date:2020-06-08, 1399/03/19
Registration timing:registered_while_recruiting
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Zainab Naeem
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 53 7511911
Email address
noorzainab666@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-01, 1399/03/12
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Hydrotherapy versus Land Based Exercises on Pain and Grip Strength in Osteoarthritis of Hand
Public title
Effects of Hydrotherapy versus Land Based Exercises on Pain and Grip Strength in Osteoarthritis of Hand
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects between the age of 40-60 years.
Criteria based on American College of Rheumatology
Exclusion criteria:
Patient with co morbidities
Traumatic injuries of hand
Hand surgery past 6 weeks
Steroid injections past 2 weeks
Cognitive or mental dysfunction
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
After assessing the eligibility based on inclusion and exclusion criteria, the participants will be requested to take part in study with written as well as informed consent. The participants will be randomly allocated into either a water-based or land based exercise group by using lottery method. The participants will be assigned the group according to even or odd number drawn by the patient from the box. The participants drawing even number will be allocated to land-based exercise group and the participants with even number will be allocated to water-based exercise group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant will be allocated to the assigned treatment group after informed consent. participant will not be aware of any other treatment given to other participant of same condition. Outcome assessor and data analyzer will be unaware of the treatment given to the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah College of Rehabilitation Sciences (RCRS) Research Ethical Committee (REC)
Street address
Near Hajj Complex, I-14, Islamabad, Islamabad Capital Territory
City
Islamabad
Postal code
46000
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
REC/RCRS/20/1011
Health conditions studied
1
Description of health condition studied
Hand osteoarthritis, which is the most frequently occurring joint disease, commonly affecting first carpometacarpal joint, interphalangeal joints and distal and proximal interphalangeal joints (DIP and PIP). Functional limitations of hand osteoarthritis are pain, decreased hand strength and flexibility, and inhibition of activity and limitation of participation in functional tasks. Distorted physical appearance, lack of activity, and great loss of mastery may compromised the role of hand as well as self-identity
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and, 2 weeks, 6 months
Method of measurement
Numerical Pain Rating Scale
2
Description
Grip Strength
Timepoint
before intervention and, 2 weeks, 6 months
Method of measurement
Hand Held Dynamometer
Secondary outcomes
1
Description
Hand function
Timepoint
Before intervention and, 2 weeks, 6 months
Method of measurement
Functional Index for Hand Osteoarthritis (FIHOA)
Intervention groups
1
Description
Intervention group 1: Water based Exercises (Hydrotherapy)