- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07595419
Treatment of de Quervain's Tendinopathy With Eccentric Training Program
Treatment of de Quervain's Tendinopathy With Eccentric Training Program [A de Quervain-féle tendinopátia kezelése Excentrikus tréninggel]
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
De Quervain's tendinopathy is a painful disorder of the first dorsal extensor compartment of the wrist that can impair thumb motion, grip-related activities, and overall hand function. The study was based on the rationale that de Quervain's tendinopathy is increasingly regarded as a degenerative rather than primarily inflammatory condition, and that eccentric loading may therefore represent a relevant conservative treatment approach. The purpose of the study was to evaluate the clinical effectiveness of a structured eccentric training program in adults with persistent de Quervain's tendinopathy after unsuccessful prior conservative management.
Eligible participants were adults with a medical diagnosis of de Quervain's tendinopathy who reported pain in the region of the radial styloid, had a positive stepped Finkelstein test, and did not report radiating arm pain during testing. Participants had a history of at least one unsuccessful conservative treatment before enrolment. Exclusion criteria included expected surgical intervention, concurrent alternative treatment during the exercise program, unclear diagnosis, inability to comply with the exercise instructions or follow-up schedule, participation in another similar study, and minor age.
This was a single-arm interventional study in which all enrolled participants received the same structured eccentric training program. After initial instruction, participants performed the exercise program at home for 8 weeks, with 1 to 5 sessions daily on at least 5 days per week. The protocol described progressive exercise stages across the intervention period, with more frequent supervision during the first 4 weeks and weekly supervision thereafter. Participants were also instructed to modify daily activities, reduce use of the painful hand, increase reliance on the unaffected side, when possible, incorporate rest periods during repetitive hand activity, and document exercise completion in a calendar.
Outcome assessment focused on pain and function. Data collection included pain intensity measured with the Numeric Pain Rating Scale, upper-limb disability measured with the Quick Disabilities of the Arm, Shoulder and Hand questionnaire, wrist-specific pain and function measured with the Patient-Rated Wrist Evaluation, and pain distribution recorded using predefined hand regions. The manuscript also described clinical evaluation of range of motion and muscle strength, while the research plan outlined baseline anamnesis, physical examination, and diagnostic confirmation procedures. Assessments were performed at baseline and at week 8, and for those whose program was prolonged, also at week 12.
According to the manuscript, some participants required extension of the intervention to 12 weeks because the expected improvement had not occurred by week 8 in the context of insufficient exercise regularity. The protocol further specified post-treatment follow-up contacts at weeks 10 and 12 and approximately 6 months after treatment initiation, with additional in-person reassessment if recurrent pain was reported. In this retrospective registry description, these follow-up procedures are described as protocol-specified elements in order to avoid overstating information not fully detailed in the manuscript results section.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Budapest, Maďarsko, 1088
- Semmelweis University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Expected surgical intervention or concurrent alternative therapies.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Eccentric training
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.
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Eccentric training consists of exercises in which the muscle contracts under load while lengthening, typically during the controlled lowering or deceleration phase of movement.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in pain intensity measured by Numeric Pain Rating Scale (NPRS)
Časové okno: Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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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.
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Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Change in hand and upper-limb disability measured by QuickDASH Part 1
Časové okno: Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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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.
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Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Change in work-related hand function measured by QuickDASH Work Module
Časové okno: Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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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.
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Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Change in wrist pain and function measured by Patient-Rated Wrist Evaluation (PRWE)
Časové okno: Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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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.
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Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in number of painful regions around the thumb and wrist
Časové okno: Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Pain distribution was assessed by asking participants to mark painful areas on standardized hand diagrams showing dorsal, lateral, and palmar views of the hand.
The thumb and surrounding region were divided into 14 predefined regions, and the number of painful regions was recorded.
Lower values indicate a smaller extent of pain distribution.
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Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Change in wrist and thumb range of motion
Časové okno: Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Range of motion of the wrist and thumb was evaluated during the physical examination to document clinical change over the course of treatment.
The research plan describes angle-based examination of wrist and thumb movement, and the manuscript states that range of motion was evaluated before and after treatment.
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Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Change in thumb muscle strength
Časové okno: Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Thumb muscle strength was evaluated during the clinical examination to assess functional improvement during treatment.
The research plan specifies examination of abductor pollicis longus and extensor pollicis brevis muscle strength, and the manuscript reports that muscle strength was evaluated before and after treatment.
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Baseline (Week 1) and Week 8; additionally at Week 12 for participants whose treatment was extended.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Katalin Lenti, PhD, Semmelweis University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 408-2/2018/EÜIG
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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