The effect of hand exercise on hand functional indexes in patients with osteoarthritis
Design
Clinical trial with intervention and control group, Double blind, randomized with sample size of 40 Patients.
Forty packed envelopes are prepared for the patients. Rheumatologist will randomly give the patient an envelope after the diagnosis and refer him to the therapist ,who will exercise the patient or place him on the waiting list according to the envelope type. Therefore, the researcher, patient, and rheumatologist do not know the intervention type.
Settings and conduct
The place of study will be Rheumatology Clinic of Zanjan Vali-e-asr Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over the age of 40 who have clinical symptoms of hand osteoarthritis; the presence of bouchard nodule,or heberden nodule in the interdigital joints, of hand fingers ; Symptoms of osteoarthritis in hand x-rays.
Non-inclusioncriteria: Participate in exercise therapy for hands in the last 6 months; Hand Intra-articular injection in the last 3 months; History of hand joint replacement or joint prosthesis; patients who candidate undergoing surgery during the study; Participate in other interventional studies; Use of cane and walker and armpit; recent use of therapeutic creams.
Intervention groups
Intervention group: A group of 20 patients will be treated at home for 4 weeks. Control group: The second group includes 20 patients will be in a waiting list. After 4 weeks, this group will also do home exercise.
Main outcome variables
Hand function; Hand power; Hand pain; Hand fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190715044220N1
Registration date:2020-01-24, 1398/11/04
Registration timing:registered_while_recruiting
Last update:2020-01-24, 1398/11/04
Update count:0
Registration date
2020-01-24, 1398/11/04
Registrant information
Name
Iraj Alibiglou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3302 3236
Email address
iraj-ab@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of hand exercise on functional indexes of hand in patients with hand osteoarthritis
Public title
The effect of exercise on patients with osteoarthritis of hand
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over the age of 40 who have clinical symptoms of hand osteoarthritis
The presence of bouchard nodule, in the interdigital joints of the hand fingers
The presence of heberden nodule in the interdigital joints of the hand fingers
Osteoarthritis symptoms on hand X-ray
Exclusion criteria:
Participate in hands-on exercises in the last 6 months
Hand Intra-articular injection in the last 3 months
History of hand joint replacement or hand joint prosthesis
Participate in other interventional studies
Use of cane and walker and armpit
Rheumatologic disease or other hand diseases, such as CTS or tendinitis
History of hand major trauma
Patients with systemic diseases, such as diabetes and ..., who have neuropathy
patients who candidate undergoing surgery during the study
recent use of therapeutic creams
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected using simple random allocation method, taking into account entry and exit criteria and the randomization tool is the sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
40 packed envelopes are prepared for the patients. Rheumatologist will randomly give the patient an envelope after the diagnosis and refer him to the therapist ,who will exercise the patient according to the envelope type, or place him on the waiting list. Therefore, the researcher, patient, and rheumatologist do not know the intervention type.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan university of medical sciences, Azadi Sq. zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2019-07-13, 1398/04/22
Ethics committee reference number
IR.ZUMS.REC.1398.155
Health conditions studied
1
Description of health condition studied
Hand Osteoarthritis
ICD-10 code
M19.049
ICD-10 code description
osteoarthritis of hand
Primary outcomes
1
Description
Improved hand function
Timepoint
4 weeks after intervention
Method of measurement
FIHOA questionnaire
2
Description
Improved hand strength
Timepoint
4 weeks after intervention
Method of measurement
FIHOA questionnaire
3
Description
Improved hand pain
Timepoint
4 weeks after intervention
Method of measurement
FIHOA questionnaire
4
Description
Improved hand fatigue
Timepoint
4 weeks after intervention
Method of measurement
FIHOA questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of 20 patients are treated with home exercise for 4 weeks. Special Exercise for Hand Fingers Osteoarthritis (includes Finger Stretch, Make a Fist, Finger Lift and Thumb Touch which are done 10 times each exercise) will be done 3 times daily.
Category
Rehabilitation
2
Description
Control group: A group of 20 patients will be on the waiting list for home exercise after 4 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic - Zanjan Valiasr Hospital
Full name of responsible person
Alireza Sadeghi
Street address
Shariati St., Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515776978
Phone
+98 24 3302 3264
Email
Sadeghialireza@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza Shoghli
Street address
Zanjan University of Medical Sciences ,Azadi square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Email
shoghli@zums.ac.ir
Web page address
http://zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Zanjan University of Medical Sciences
Full name of responsible person
Alireaz Sadeghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatologist
Street address
Valiasr Hospital, Shariati street
City
Zanjan
Province
Zanjan
Postal code
4515776978
Phone
+98 24 3302 3264
Email
Sadeghialireza@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Sadeghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatologist
Street address
Valiasr Hospital, Shariati street
City
Zanjan
Province
Zanjan
Postal code
4515776978
Phone
+98 24 3302 3264
Email
Sadeghialireza@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Iraj Alibiglou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Valiasr Hospital, Shariati street
City
Zanjan
Province
Zanjan
Postal code
4515776978
Phone
+98 24 3302 3264
Email
iraj-ab@zums.ac.ir
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is shareable
When the data will become available and for how long
Since the end of 1398
To whom data/document is available
public
Under which criteria data/document could be used
There is no specific requirement
From where data/document is obtainable
Responsive person email address
What processes are involved for a request to access data/document
One month after the written request to Responsive person