Investigation of Thenar Muscles Morphometric Parameters in Patients With TMC OA

Thumb Osteoarthritis Clinical Trial

Official title:

Investigation of Parameters of Trapeziometacarpal Joint Configuration and Tenar Muscles in Patients With TMC OA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913935
• Other study ID #: GO 18/204
• Status: Completed
• Start date: September 5, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: June 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 15, 2020
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years

Exclusion Criteria:

• Patient with De'quervain tenosynovitis, trigger finger, entrapment neuropathy and who had undergone hand surgery were excluded.

Related Conditions & MeSH terms

• Atrophy
• Muscle Atrophy or Weakness
• Muscular Atrophy
• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Diagnostic Test:
• Muscle-Skeleton Ultrasonography
postero-anterior radiography

Locations

Country	Name	City	State
Turkey	Hacettepe University	Altindag	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Grechenig 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. — View Citation

Mohseny 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	Grip strength measurement	The grip strength will be measured in kilograms using a Jamar Hand Dynamometer	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	Pinch strength measurement	The pinch strength will be measured in kilograms using a Pinchmeter.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year