Investigation of Thenar Muscles Morphometric Parameters in Patients With TMC OA

NCT04913935 | Completed DMC

• 1 other identifier: GO 18/204
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thumb Osteoarthritis; Muscle Atrophy or Weakness

Keywords

thumb; trapeziometacarpal osteoarthritis; muscle thickness; muscle cross sectional area; hand function; hand dexterity; pain; pinch strength

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• The radial subluxation rate of the first metacarpal.

  through study completion, an average of 1 year

• Evaluation of functional status of hand

  through study completion, an average of 1 year

• Grip strength measurement

  through study completion, an average of 1 year

• Evaluation of functional status of hand

  through study completion, an average of 1 year

• Pain Assessment

  through study completion, an average of 1 year

Study Arms (2)

TMC OA

women who were diagnosed with TMC OA

Diagnostic Test: Muscle-Skeleton Ultrasonography

Control

healty volunteer women

Diagnostic Test: Muscle-Skeleton Ultrasonography

Interventions

Muscle-Skeleton Ultrasonography DIAGNOSTIC_TEST

postero-anterior radiography

Also known as: Radiography

Control; TMC OA

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Altindağ, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 19744803 BACKGROUND

• 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.

  PMID: 25482051 BACKGROUND

• 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. doi: 10.7863/jum.2000.19.11.733.

  PMID: 11065261 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy; Asthenia; Pain

Interventions

Radiography

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• ÇİĞDEM AYHAN, ASS. PROF.

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asssistant

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: June 4, 2021
• Study Start: September 5, 2019
• Primary Completion: December 28, 2019
• Study Completion: January 15, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)