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NCT Number: NCT06709911

A Comparative Study of the Efficacy of Multimodal Interventions for Tenosynovitis

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basic Manipulation Stretching

Behavioral

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.

Massage and Tui Na Manipulation

Behavioral

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.

Blood flow restriction training

Behavioral

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 training period was supervised by a professional.

Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention

Behavioral

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 kneaded 2-3 times a day for 3 minutes each time to produce a slight sensation of soreness and distension. The aim of the massage is to relieve the inflammatory reaction around the tendon, loosen muscle tension and tendon sheath adhesions and promote blood circulation and joint mobility. The cycle of intervention is 4 to 8 weeks.

Primary outcomes

  1. Visual Analogue Scale, VAS

    Time frame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)

    The VAS score consists of five dimensions of pain threshold testing: overall wrist pain, pain when extending the wrist, pain when flexing the wrist, wrist pain when resisting forearm rotation, and pain when pressing on specific parts of the wrist. Each dimension is scored on a scale of 0-10 for a total of 50 points, with lower scores indicating less pain.

  2. Mayo Wrist Score, MWS

    Time frame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)

    The scale consists of four areas: pain (25 points), function (25 points), range of motion (25 points), and grip strength (25 points) for a total of 100 points, with higher scores indicating better wrist function.

  3. Wrist strength

    Time frame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)

    An electronic grip strength device was used to measure the grip strength of the affected arm before and after the treatment, including the grip strength of the affected arm in three states; the maximum grip strength in the naturally hanging arm state, the maximum grip strength in resisted internal rotation of the forearm, and the maximum grip strength in resisted external rotation of the forearm.

  4. Range of Motion Measurement

    Time frame: Baseline, 4 weeks, (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)

    Flexion and extension angle measurements, forearm pronation and pronation angle measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Z Deng

CONTACT

[email protected]

+8613570551532

Sponsors and collaborators

Lead sponsor

Zixin Deng

Other

Registry information

Official study 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

Acronym: TGCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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