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

Overview

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.

Interventions

• Behavioral Basic Manipulation Stretching
  This group received standard hand tenosynovitis stretching therapy, which focused on the flexor and extensor muscle groups of the wrist and hand for release. Muscle tension and tendon adhesions were relieved by basic stretching maneuvers, with each intervention lasting 20-30 minutes, twice a week, over a 4- to 8-week period.
• Behavioral Massage and Tui Na Manipulation
  The group received Tui Na manipulation interventions, including pointing, pressing and rolling techniques for the tendon sheath and thumb region, focusing on the stimulation of acupoints such as Hegu, Yangchi and Waiguan. The aim of Tui Na manipulation was to relieve the inflammatory reaction around the tendon sheath, promote blood circulation and improve local function. Each intervention lasts 20-30 minutes, twice a week for 4-8 weeks.
• Behavioral Blood flow restriction training
  This group used pressurized blood flow restriction training, in which the proximal part of the temporal joint was pressurized by a pressurized device to restrict blood flow. The training consisted of low-load wrist flexion and extension, fist clenching and unclenching, and wrist rotation. The training intensity was set at 20%-50% 1RM, and the frequency was 2 times per week for 4 to 8 weeks. Pressurization was performed before training and the pressure was set in the range of 20-50 mmHg, and the
• Behavioral Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention
  This group received the combined intervention of magnetic bead pressure stimulation and Tui Na manipulation. Before treatment, the magnetic beads were applied to specific acupoints on the hand (e.g., Hegu, Ahshi, Waiguan, etc.), fixed by breathable patches, and combined with Tui Na manipulation. During Tui Na, the magnetic beads are pressed and kneaded to further enhance the stimulation effect of the acupoints. After Tui Na, the magnetic beads remain in the affected area and can be pressed and k

Primary outcome measures

• Visual Analogue Scale, VAS [Time frame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)]
• Mayo Wrist Score, MWS [Time frame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)]
• Wrist strength [Time frame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)]
• Range of Motion Measurement [Time frame: Baseline, 4 weeks, (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06709911 · University of Leeds

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗