Clinical trial NCT06709911: A Comparative Study of the Efficacy of Multimodal Interventions for Tenosynovitis
Official title: Efficacy of Multimodal Interventions for Tenosynovitis: Comparative Analysis of Basic Manipulation, Tui Na, Blood Flow Restriction Training, and Magnetic Bead Application Combined With Tui Na
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: TGCT
Lead sponsor: First People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficacy of four treatments in patients with hand tenosynovitis. The main questions it aims to answer are:

Which treatment most effectively reduces pain and improves joint function? How do the treatments differ in improving strength and range of motion? Researchers will compare four groups-basic manipulation, tui na manipulation, blood flow restriction (BFR) training, and magnetic bead application combined with tui na-to see if there are differences in clinical outcomes.

Participants will:

Be randomly assigned to one of the four treatment groups. Receive interventions twice a week for 4-8 weeks. Undergo assessments of pain, function, range of motion, and strength before, during, and after the treatment period.


Eligibility criteria: Inclusion Criteria:

* 18 to 60 years of age.
* Case diagnosis reporting symptoms of tenosynovitis of the hand for at least 3 months.
* Constant-Murley Shoulder Score: score less than or equal to 60.
* Dysfunction of the Upper Extremity, Shoulder, and Hand Scale (DASH Scale): DASH score less than 40.
* Mayo Wrist Score: score less than or equal to 60.
* Positive test results on 2 or more scales during pre-test screening.
* No structural lesions or congenital malformations of the hand or wrist.
* Finkelstein's Test: Positive (pain occurs when patient holds thumb and bends wrist toward little finger).
* Fist Clenching Test: Positive (pain increases when patient clenches fist and attempts to bend wrist toward little finger).
* No prior hand or wrist surgery or external injuries.
* No serious cardiac, pulmonary, neurological, or other systemic diseases.
* Sufficient exercise capacity to complete exercise loads of required intensity and duration.

Exclusion Criteria:

* Not between 18 and 60 years of age.
* Failed wrist function screening.
* Failed special tests.
* Presence of structural wrist lesions or congenital wrist deformities.
* History of wrist surgery, significant trauma, or wounds.
* Problems with skin irritation, infections, or open wounds.
* Conditions like anemia or low blood pressure.
* Serious cardiac, pulmonary, neurological, or other systemic diseases.
* Inability to cooperate with trial requirements or refusal to participate.

Primary outcomes:
measure: Visual Analogue Scale, VAS
timeFrame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
measure: Mayo Wrist Score, MWS
timeFrame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
measure: Wrist strength
timeFrame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
measure: Range of Motion Measurement
timeFrame: Baseline, 4 weeks, (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Xin Z Deng
role: PRINCIPAL_INVESTIGATOR
References: