Effect of Combined strengthening of the Opponens pollicis and the First dorsal interosseous muscles on the clinical outcomes in thumb carpometacarpal joint osteoarthritis
Determining the effect of strengthening the muscles of the first interosseous muscle and pollicis apponus on clinical outcomes in patients with carpometacarpal joint osteoarthritis of the thumb in Tehran.
Design
Clinical trial
Double blind
Simple randomization
Settings and conduct
Akhtar Hospital in Tehran
Blinding of assessor and participants
Participants/Inclusion and exclusion criteria
Patients with osteoarthritis of the carpometacarpal joint of the thumb who are diagnosed by a trained orthopedist in stages 2, 1 and 3 of the Eaton-Littler-Burton criteria based on radiographic evidence.
The hand with osteoarthritis of the carpometacarpal joint of the thumb should be the patient's dominant hand.
A score of 23 and above on the Mental Health Scale (MMSE)
Average pain ≥ 30 on a 100 mm VAS scale, where 0 means no pain and 100 the worst imaginable pain during the past 30 days and 48 hours before the baseline assessment.
Not suffering from crystal arthritis
Not having autoimmune arthritis
Absence of hemochromatosis
The absence of fibromyalgia, which is checked by an orthopedic doctor along with other criteria at the admission stage, and the patient is referred.
No hand surgery in the past 6 months or planned in the next 6 months
No intra-articular injection of hyaluronic acid in the affected joint in the last 6 months and intra-articular steroid in the affected joint in the last month
No significant damage to the affected joint in the last 6 months
Intervention groups
The control and intervention groups receive exercise therapy in the first dorsal interosseus and apponus pollicis muscles
Main outcome variables
Pain; grip strength; pinching strength; range of motion; Muscle strength; social participation; dexterity; dislocation of joint
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240117060714N1
Registration date:2024-03-25, 1403/01/06
Registration timing:registered_while_recruiting
Last update:2024-03-25, 1403/01/06
Update count:0
Registration date
2024-03-25, 1403/01/06
Registrant information
Name
Mobina Jajarmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3227 1315
Email address
mobinajajarmi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-25, 1402/11/05
Expected recruitment end date
2024-05-18, 1403/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Combined strengthening of the Opponens pollicis and the First dorsal interosseous muscles on the clinical outcomes in thumb carpometacarpal joint osteoarthritis
Public title
Effect of Combined exercise therapy on the clinical outcomes in patients with thumb carpometacarpal joint osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with thumb carpometacarpal joint osteoarthritis who are diagnosed by a trained orthopedist in stage 2, 1 and 3 of the Eaton-Littler-Burton criteria based on radiographic evidence
The hand with the thumb carpometacarpal joint osteoarthritis must be the patient's dominant hand.
Average pain ≥ 30 on a 100 mm VAS scale, where 0 means no pain and 100 the worst imaginable pain during the past 30 days and in the 48 hours before the baseline assessment
Lack of crystal arthritis
Lack of hemochromatosis
Lack of autoimmune arthritis
Lack of fibromyalgia which is checked by the orthopedist
Lack of hand surgery Last 6 months or planned in the next 6 months
No intra-articular injection of hyaluronic acid in the affected joint in the last 6 months and no intra-articular steroid in the affected joint in the last month
No significant damage to the affected joint in the last 6 months
Exclusion criteria:
A score lower than 23 on the mini mental state examination
Planning hand surgery in the next 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation
Simple random sampling
Randomization Unit: Individual
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the evaluator does not know which control or intervention group were evaluated.
The patients are aware of the nature of the treatment, but since each treatment is applied individually, they do not know exactly whether they will receive the exercises of the control group or the intervention group.
At the end of the study, the control group will receive the full exercises of the intervention group on one page with explanations, and if the method is meaningful, they can refer to us for additional treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University Medical Sciences
Street address
First floor, Andisheh Ave, Andisheh 8, Jajarm Town
City
Jajarm
Province
North Khorasan
Postal code
9441745143
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.580
Health conditions studied
1
Description of health condition studied
Thumb carpometacarpal joint osteoarthritis
ICD-10 code
S63.04
ICD-10 code description
Subluxation and dislocation of carpometacarpal joint of thumb
Primary outcomes
1
Description
Improvement of pain scores in vas
Timepoint
Before the beginning of the intervention - the end of sessions 12 and 18
Method of measurement
Visual analogue scale
2
Description
Social participation based on copm
Timepoint
Before the intervention and the end of sessions 12 and 18
Method of measurement
Canadian Occupational Performance Measure
3
Description
Grip strength based on dynamometer
Timepoint
Before the intervention and the end of sessions 12 and 18
Method of measurement
Dynamometer
4
Description
Pinch strength
Timepoint
Before the intervention and the end of sessions 12 and 18
Method of measurement
Pinch gauge
5
Description
Range of motion
Timepoint
Before the intervention and the end of sessions 12 and 18
Method of measurement
Goniometry
6
Description
Muscle strength
Timepoint
Before the intervention and the end of sessions 12 and 18
Method of measurement
Manual muscle testing
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Participants will be treated for 6 weeks, 3 sessions of 45 minutes per week, a total of 18 sessions. The evaluator and participants are double-blind, and the evaluations are recorded before the beginning of the interventions, at the end of the 12th and 18th sessions. The exercises include pulling the Styrofoam ball, extending the carpometacarpal joint of the thumb, and adduction and abduction of the thumb and index finger and will performed with 10 repetitions.
Category
Rehabilitation
2
Description
Intervention group: Participants will be treated for 6 weeks, 3 sessions of 45 minutes per week, a total of 18 sessions. The evaluator and the participants are double-blind, and the evaluations are recorded before the intervention, at the end of the 12th and 18th sessions. We have 6 mobility exercises and 6 strengthening exercises, which are divided into even and odd sessions; The reason for combining these two is to prevent muscle fatigue. Even sessions: thumb opposition, index finger abduction, thumb abduction, Styrofoam ball pulling, thumb carpometacarpal joint extension, thumb adduction and abduction and index. Odd sessions: finger flexion thumb, index finger abduction, flexion of the interphalangeal joint of the thumb, aquarium net, flexion of the metacarpophalangeal joint of the thumb
5th floor, Building 2, Shahid Beheshti University of Medical Sciences and Healthcare Services, next to Taleghani Hospital, Shahid Abbas Arabi Street (Parvaneh), Yemen Street, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
22439780 -22439781
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Asghar Jamebozorgi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Nezam Abad Ave, Emam Ali Highway, Tehran
City
Tehran
Province
Tehran
Postal code
021 7754 2057
Phone
+98 21 7754 2057
Email
aas.bozorg@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Kalantari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Nezam Abad Ave, Emam Ali Highway, Tehran
City
Tehran
Province
Tehran
Postal code
021 7754 2057
Phone
+98 21 7754 2057
Email
Mn_kalantari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mobina Jajarmi
Position
Mater Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
First floor, Andisheh Ave, Andisheh 8, Jajarm Town
City
Jajarm
Province
North Khorasan
Postal code
9441745143
Phone
+98 915 602 8681
Email
mobinajajarmi@sbmu.ac.ir
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
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Information about the data before and after the intervention will be allowed to access.
When the data will become available and for how long
Access starts 1 year after the publication of the article.
To whom data/document is available
Only people who are affiliated with academic institutions will have access
Under which criteria data/document could be used
The use of data before data collection in similar research is not allowed due to the risk of bias.