UMIN-ICDS Clinical Trial

Public title

Prospective study of whether practicing thumb pronation improves pain and hand function in thumb CMC osteoarthritis

Acronym

Thumb Pronation Practice Study (TPP Study)

Scientific Title

A prospective study of the effect of thumb pronation exercise on pain reduction and functional improvement in patients with thumb CMC osteoarthritis.

Scientific Title:Acronym

CMC-PRONE Study

Region

Japan

Condition

Thumb carpometacarpal arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aims of this study are to develop a novel exercise therapy for thumb carpometacarpal (CMC) osteoarthritis, to evaluate its usefulness, and ultimately to establish an evidence-based exercise therapy for this condition. In addition, to facilitate simplification, standardization, and wider implementation of the developed exercise therapy, we aim to develop exercise-therapy support devices, including both non-digital and digital options. Because thumb CMC osteoarthritis is a highly prevalent age-related disease, if exercise therapy can improve symptoms and help prevent disease progression, it is expected not only to enhance patients' activities of daily living (ADL) and quality of life (QOL), but also to contribute to reducing healthcare costs, which is an urgent issue in Japan.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Patient-rated questionnaire (Michigan Hand Outcome Questionnaire) scores

Key secondary outcomes

Pain intensity measured by the Numeric Rating Scale (NRS), Disabilities of the Arm, Shoulder and Hand (DASH) score, Patient Global Assessment, Treatment satisfaction, Joint range of motion (ROM), Grip strength, Pinch strength, Pain location, Nail Tip Angle of Thumb-Ring Finger Opposition, Thumb pronation angle, Surface electromyography amplitude ratio

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

In addition to regular rehabilitation, we provide instruction on thenar muscle training exercises, including opponens pollicis training.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Thumh CMC osteoarthrits group:
Those diagnosed with CM joint arthropathy of the thumb. Those diagnosed with the above disease by an orthopedic specialist based on medical history, physical findings, and imaging tests (plain X-rays). Those aged 20 years or older at the time of consent. Those who have given written consent to participate in this study.

Key exclusion criteria

Thumh CMC osteoarthrits group:
Those with a history of trauma to the upper limbs or cervical spine. Those with rheumatoid arthritis or other collagen diseases. Those with a history of treatment for malignant tumors or other conditions affecting the upper limbs, shoulder girdle, or neck. Those with neurological paralysis due to cerebrovascular disease or other conditions. Those who have already received treatment at another hospital. Those deemed inappropriate by the principal investigator or co-investigator

Target sample size

25

Name of lead principal investigator

1st name	Tomoyuki
Middle name
Last name	Kuroiwa

Organization

Graduate School of Medical and Dental Sciences, Institute of Science Tokyo

Division name

Department of Orthopaedic and Spinal Surgery

Zip code

1138510

Address

1-5-45, yushima, bunkyo-ku, Tokyo

TEL

0358035279

Email

kuroiwa.orth@tmd.ac.jp

Name of contact person

1st name	Tomoyuki
Middle name
Last name	Kuroiwa

Organization

Graduate School of Medical and Dental Sciences, Institute of Science Tokyo

Division name

Department of Orthopaedic and Spinal Surgery

Zip code

1138510

Address

1-5-45, yushima, bunkyo-ku, Tokyo

TEL

0358035279

Homepage URL

Email

kuroiwa.orth@tmd.ac.jp

Institute

Institute of Science Tokyo

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institute of Science Tokyo, Ethical Review Committee

Address

1-5-45, yushima, bunkyo-ku, Tokyo

Tel

+81-3-5803-4547

Email

rinri.adm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

05

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

01

Month

07

Day

Date of IRB

Anticipated trial start date

2026

Year

04

Month

30

Day

Last follow-up date

2027

Year

07

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

01

Month

07

Day

Last modified on

2026

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068960