NCT07595419

Brief Summary

This completed clinical study evaluated whether a structured eccentric training program reduced pain and improved hand and wrist function in adults with medically diagnosed de Quervain's tendinopathy whose symptoms had persisted despite previous conservative treatment. The main questions addressed were:

  • Did eccentric training reduce pain intensity and the extent of pain distribution in participants with de Quervain's tendinopathy?
  • Did eccentric training improve hand and wrist function in daily activities and work-related tasks? Participants received a structured eccentric exercise program for 8 weeks. After instruction by a physiotherapist, they performed the exercises at home 1 to 5 times daily, at least 5 days per week, and adherence was monitored during supervised visits. Participants also recorded exercise sessions in a calendar. Assessments were conducted at baseline and at week 8 and included pain evaluation, pain-area mapping, and validated hand and wrist function questionnaires. For participants with insufficient adherence or incomplete recovery, the intervention period was extended to 12 weeks, with an additional assessment at week 12. Post-treatment follow-up was specified in the study protocol at weeks 10 and 12 and approximately 6 months after treatment initiation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

April 13, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

de Quervain's tenosynovitisde Quervain diseasetendinopathyeccentric trainingphysiotherapyphysical therapy modalities

Outcome Measures

Primary Outcomes (4)

  • Change in pain intensity measured by Numeric Pain Rating Scale (NPRS)

    Pain intensity was assessed using the Numeric Pain Rating Scale (0 to 10) based on the participant's reported strongest pain. Lower scores indicate less pain. This outcome evaluated change in pain severity after the eccentric training program.

    Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.

  • Change in hand and upper-limb disability measured by QuickDASH Part 1

    Change in hand and upper-limb disability measured by QuickDASH Part 1 Description: Hand and upper-limb disability in everyday activities was assessed using Part 1 of the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). Lower scores indicate better function and less disability.

    Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.

  • Change in work-related hand function measured by QuickDASH Work Module

    Work-related hand function was assessed using the optional work module of the QuickDASH questionnaire. Lower scores indicate better work-related function and less disability. This outcome was assessed only in participants for whom the work module was applicable.

    Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.

  • Change in wrist pain and function measured by Patient-Rated Wrist Evaluation (PRWE)

    Wrist pain and wrist-related functional difficulty were assessed using the Patient-Rated Wrist Evaluation questionnaire. Lower scores indicate less pain and better wrist function. This outcome evaluated symptom and function change after eccentric training.

    Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.

Secondary Outcomes (3)

  • Change in number of painful regions around the thumb and wrist

    Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.

  • Change in wrist and thumb range of motion

    Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.

  • Change in thumb muscle strength

    Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.

Study Arms (1)

Eccentric training

EXPERIMENTAL

After learning the training, the patients performed a structured eccentric training program for eight weeks, with 1-5 daily sessions, and at least five times a week. Participants' adherence was controlled during the weekly meetings. In case of inconsistent adherence, patients who did not perform the exercises with sufficient regularity received the treatment for 12 weeks.

Procedure: Eccentric training

Interventions

Eccentric training consists of exercises in which the muscle contracts under load while lengthening, typically during the controlled lowering or deceleration phase of movement.

Eccentric training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 years or older.
  • Medical diagnosis of de Quervain's tendinopathy.
  • Increased pain in the area of the radial styloid process.
  • Positive stepped Finkelstein test.
  • No pain radiating to the arm during the stepped Finkelstein test.
  • History of at least one unsuccessful conservative treatment.
  • No other treatment received during the eccentric training intervention.

You may not qualify if:

  • Expected surgical intervention or concurrent alternative therapies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

De Quervain DiseaseTendinopathy

Condition Hierarchy (Ancestors)

Tendon EntrapmentMuscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Katalin Lenti, PhD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
College Professor

Study Record Dates

First Submitted

April 13, 2026

First Posted

May 19, 2026

Study Start

January 7, 2020

Primary Completion

February 24, 2023

Study Completion

February 24, 2023

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations