Thumb OsteoarthritisNCT04913935
Investigation of Thenar Muscles Morphometric Parameters in Patients With TMC OA
An observational study of Thumb Osteoarthritis and Muscle Atrophy or Weakness, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aimed to investigate the morphometric parameters tenar muscles and joint configuration in patients with trapeziometacarpal osteoarthritis (TMC OA) osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level and hand dexterity. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thumb Osteoarthritis, Muscle Atrophy or Weakness
- What is being tested?
- Muscle-Skeleton Ultrasonography
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2019to 15 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years and who had the intellectual capacity to give informed consent for the treatment were included in the study.
Who may be able to join
- Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years
Who cannot join
- Patient with De'quervain tenosynovitis, trigger finger, entrapment neuropathy and who had undergone hand surgery were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Parameters of Trapeziometacarpal Joint Configuration and Tenar Muscles in Patients With TMC OA
In this study, investigators aimed to investigate the morphometric parameters tenar muscles and joint configuration in patients with trapeziometacarpal osteoarthritis (TMC OA) osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level and hand dexterity.
Read the detailed description
Patients diagnosed with trapeziometacarpal osteoarthritis and healthy subjects will be included in the study. Thickness and cross-sectional area measurements of the thenar muscles of the patient and healthy volunteers will be performed by using Shimadzu SDU 1200-Pro ultrasound system with an 8-10 MHz linear probe. To improve the image quality and to avoid muscle compression, water immersion ultrasonography will be preferred and the hands will be positioned in a water-filled plastic container. The thenar muscles will be imaged in hands of each subject.
In this study, poster-anterior radiographic imaging will be performed. The osteoarthritis stage will be determined on the radiographic image. Three different measurements will be performed on radiography: radial subluxation of the first metacarpal base (RS), articular width (AW) of the first metacarpal, and the distance between the ulnar articular facet of the trapezium and the ulnar edge of the metacarpal (U). RS / AW ratio will be calculated.
Because TMC OA caused pain and affect performance, especially during grip activities in the osteoarthritis and control groups will be tested.
Grip strength will also be measured.
- Conditions
- Thumb Osteoarthritis, Muscle Atrophy or Weakness
- Being tested
- Muscle-Skeleton Ultrasonography
- Keywords
- thumb, trapeziometacarpal osteoarthritis, muscle thickness, muscle cross sectional area, hand function, hand dexterity, pain, pinch strength
- Medical subject headings
- Muscular Atrophy, Asthenia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle-Skeleton UltrasonographyDiagnostic test
Also called Radiography
postero-anterior radiography
| Study group | Role | What they receive |
|---|---|---|
| TMC OA | women who were diagnosed with TMC OA Receives: Diagnostic Test: Muscle-Skeleton Ultrasonography | |
| Control | healty volunteer women Receives: Diagnostic Test: Muscle-Skeleton Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound-based muscle cross-sectional area of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.
USG procedures will performed on patients with TMC OA and healthy volunteers. Cross-sectional area measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.
Measured: through study completion, an average of 1 year
Ultrasound-based muscle thickness of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.
USG procedures will performed on patients with TMC OA and healthy volunteers.Thickness measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
The radial subluxation rate of the first metacarpal.
In this study, while PA radiographic imaging will performed, the elbows will ppositioned in 90 ° flexion, wrists in neutral position, MCP joints at 15-20 ° flexion and nails parallel to each other. During the scanning, patient will toush his thumbs together with maximum force. Three different measurements will made: the radial subluxation (RS) of the first metacarpal base, the articular width of the first metacarpal (AG), and the distance between the ulnar articular facet of the trapezium and the ulnar edge of the metacarpal (U) in milimeter will measured. RS/AG rate will calculated.
Measured: through study completion, an average of 1 year
Evaluation of functional status of hand
Disability of Arm Shoulder and Hand (DASH) will used to determine functional status of hand.The total score is 100, and higher scores indicate a worse functional level.
Measured: through study completion, an average of 1 year
Grip strength measurement
The grip strength will be measured in kilograms using a Jamar Hand Dynamometer
Measured: through study completion, an average of 1 year
Evaluation of functional status of hand
Michigan Hand Outcomes Questionnaire (MHQ) includes 6 subtitles, namely general hand function, ADL, pain, work, aesthetics and satisfaction, and these headings are filled in for theight and left hand. Score calculation for each title is calculated separately. The total score is 100, high scores mean better functional status.
Measured: through study completion, an average of 1 year
Pain Assessment
Pain intensity was evaluated using the visual analog scale (Visual Analogue Scale, VAS). The patients were told that the number "0" means "no pain" and "10" means "unbearable pain" on a 10 cm horizontal line. Patients were asked to mark the severity of pain during rest and activity on this line. The marked place was measured and the result was recorded as the intensity of pain in cm.
Measured: through study completion, an average of 1 year
Pinch strength measurement
The pinch strength will be measured in kilograms using a Pinchmeter.
Measured: through study completion, an average of 1 year
Minnesota hand skill test
Hand skills are evaluated in two different ways, namely placing the discs in their slots and rotating them. People are told that this test is a performance test and they are asked to complete the test as soon as possible. In the insertion part of the test, the patient is asked to take the discs one by one using one hand and put them in the appropriate slots respectively. In the rotating part of the test, the patient is asked to move the discs placed in their nests by rotating the discs in the upper right corner towards the left row. Both tests are repeated 3 times and the result is recorded in seconds.
Measured: through study completion, an average of 1 year
9 Hole hand skill test
This test, which is used to evaluate fine hand skills, is carried out by taking 9 pins from the ground and placing them in the holes and removing them. The test time is approximately 10 minutes. After the patient is told that the test is a performance test and that it will be timed, he is asked to insert the pins first and then remove them as soon as possible. The test is performed twice consecutively on both hands and the two attempts are averaged, the results are recorded in seconds.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start5 Sep 2019
- Primary completion28 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray Karademir, Hacettepe University
- Investigators
- ÇİĞDEM AYHAN, ASS. PROF., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913935
- Sponsor's protocol ID
- GO 18/204
- Status last verified
- Jun 2021
- First submitted
- 8 Aug 2019
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolf JM, Oren TW, Ferguson B, Williams A, Petersen B. The carpometacarpal stress view radiograph in the evaluation of trapeziometacarpal joint laxity. J Hand Surg Am. 2009 Oct;34(8):1402-6. doi: 10.1016/j.jhsa.2009.06.030. Epub 2009 Sep 10.
PubMed 19744803Mohseny B, Nijhuis TH, Hundepool CA, Janssen WG, Selles RW, Coert JH. Ultrasonographic quantification of intrinsic hand muscle cross-sectional area; reliability and validity for predicting muscle strength. Arch Phys Med Rehabil. 2015 May;96(5):845-53. doi: 10.1016/j.apmr.2014.11.014. Epub 2014 Dec 4.
PubMed 25482051Grechenig W, Peicha G, Weiglein A, Tesch P, Lawrence K, Mayr J, Preidler KW. Sonographic evaluation of the thenar compartment musculature. J Ultrasound Med. 2000 Nov;19(11):733-41. doi: 10.7863/jum.2000.19.11.733.
PubMed 11065261
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Parameters of Trapeziometacarpal Joint Configuration and Tenar Muscles in Patients With TMC OA
- ClinicalTrials.gov ID
- NCT04913935
- Acronym / sponsor ID
- GO 18/204
- Conditions
- Thumb Osteoarthritis, Muscle Atrophy or Weakness
- Keywords
- thumb, trapeziometacarpal osteoarthritis, muscle thickness, muscle cross sectional area, hand function, hand dexterity, pain, pinch strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators aimed to investigate the morphometric parameters tenar muscles and joint configuration in patients with trapeziometacarpal osteoarthritis (TMC OA) osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level and hand dexterity.
Detailed description
Patients diagnosed with trapeziometacarpal osteoarthritis and healthy subjects will be included in the study. Thickness and cross-sectional area measurements of the thenar muscles of the patient and healthy volunteers will be performed by using Shimadzu SDU 1200-Pro ultrasound system with an 8-10 MHz linear probe. To improve the image quality and to avoid muscle compression, water immersion ultrasonography will be preferred and the hands will be positioned in a water-filled plastic container. The thenar muscles will be imaged in hands of each subject.
In this study, poster-anterior radiographic imaging will be performed. The osteoarthritis stage will be determined on the radiographic image. Three different measurements will be performed on radiography: radial subluxation of the first metacarpal base (RS), articular width (AW) of the first metacarpal, and the distance between the ulnar articular facet of the trapezium and the ulnar edge of the metacarpal (U). RS / AW ratio will be calculated.
Because TMC OA caused pain and affect performance, especially during grip activities in the osteoarthritis and control groups will be tested.
Grip strength will also be measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMC OA | – | Diagnostic Test: Muscle-Skeleton Ultrasonographywomen who were diagnosed with TMC OA |
| Control | – | Diagnostic Test: Muscle-Skeleton Ultrasonographyhealty volunteer women |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years and who had the intellectual capacity to give informed consent for the treatment were included in the study.
Key inclusion criteria (1 listed)
- Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years
Key exclusion criteria (1 listed)
- Patient with De'quervain tenosynovitis, trigger finger, entrapment neuropathy and who had undergone hand surgery were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle-Skeleton UltrasonographyAlso: Radiographypostero-anterior radiography | Diagnostic test | Control, TMC OA |
Primary outcome
Ultrasound-based muscle cross-sectional area of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.
Time frame: through study completion, an average of 1 year
USG procedures will performed on patients with TMC OA and healthy volunteers. Cross-sectional area measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.
Ultrasound-based muscle thickness of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.
Time frame: through study completion, an average of 1 year
USG procedures will performed on patients with TMC OA and healthy volunteers.Thickness measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.
8 secondary outcomes
The radial subluxation rate of the first metacarpal.
Time frame: through study completion, an average of 1 year
Evaluation of functional status of hand
Time frame: through study completion, an average of 1 year
Grip strength measurement
Time frame: through study completion, an average of 1 year
Evaluation of functional status of hand
Time frame: through study completion, an average of 1 year
Pain Assessment
Time frame: through study completion, an average of 1 year
Pinch strength measurement
Time frame: through study completion, an average of 1 year
Minnesota hand skill test
Time frame: through study completion, an average of 1 year
9 Hole hand skill test
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Background: PubMed 19744803Wolf JM, Oren TW, Ferguson B, Williams A, Petersen B. The carpometacarpal stress view radiograph in the evaluation of trapeziometacarpal joint laxity. J Hand Surg Am. 2009 Oct;34(8):1402-6. doi: 10.1016/j.jhsa.2009.06.030. Epub 2009 Sep 10.
- Background: PubMed 25482051Mohseny B, Nijhuis TH, Hundepool CA, Janssen WG, Selles RW, Coert JH. Ultrasonographic quantification of intrinsic hand muscle cross-sectional area; reliability and validity for predicting muscle strength. Arch Phys Med Rehabil. 2015 May;96(5):845-53. doi: 10.1016/j.apmr.2014.11.014. Epub 2014 Dec 4.
- Background: PubMed 11065261Grechenig W, Peicha G, Weiglein A, Tesch P, Lawrence K, Mayr J, Preidler KW. Sonographic evaluation of the thenar compartment musculature. J Ultrasound Med. 2000 Nov;19(11):733-41. doi: 10.7863/jum.2000.19.11.733.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ÇİĞDEM AYHAN, ASS. PROF. study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thumb Osteoarthritis and Muscle Atrophy or Weakness, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound-based muscle cross-sectional area of thenar muscles in this study will investigate in TMC OA patients and healthy subjects. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913935, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.