A Comparative Study of the Efficacy of Multimodal Interventions for Tenosynovitis (NCT06709911) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Comparative Study of the Efficacy of Multimodal Interventions for Tenosynovitis
45 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Scale, VAS
Timeframe: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
2
Mayo Wrist Score, MWS
Timeframe: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
3
Wrist strength
Timeframe: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
4
Range of Motion Measurement
Timeframe: Baseline, 4 weeks, (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)