A Comparative Study of the Efficacy of Multimodal Interventions for Tenosynovitis

NCT ID: NCT06709911

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-04-01

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.

Conditions

TGCT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Basic Manipulation Stretching Group

Focuses on relieving muscle tension and tendon adhesions in the flexor and extensor muscles of the wrist and hand. The intervention aims to improve soft tissue elasticity, enhance joint mobility, and restore functional wrist and hand movement through systematic stretching techniques.

Group Type: EXPERIMENTAL

Basic Manipulation Stretching

Intervention Type: 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

Uses a combination of massage and Tui Na techniques to target tendon sheaths and surrounding tissues in the wrist and hand. Specific acupoints, such as Hegu, Yangchi, and Waiguan, are stimulated to alleviate inflammation, improve blood circulation, and restore joint functionality. The intervention aims to enhance soft tissue elasticity and range of motion while reducing pain and stiffness.

Group Type: EXPERIMENTAL

Massage and Tui Na Manipulation

Intervention Type: 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 group

Applies localized blood flow restriction using pressurized equipment on the proximal forearm, combined with low-load exercises such as wrist flexion, extension, clenching, and rotation. The goal is to stimulate muscle adaptation and strength development while minimizing mechanical stress on the joints, ultimately improving hand and wrist functionality.

Group Type: EXPERIMENTAL

Blood flow restriction training

Intervention Type: 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 Group

Combines magnetic bead pressure stimulation and Tui Na manipulation to enhance therapeutic outcomes. Magnetic beads are applied to specific acupoints on the hand and wrist (e.g., Hegu, Ashi, Waiguan) to stimulate circulation and reduce tension. Tui Na techniques, including pressing, kneading, and massaging, further enhance the stimulation, alleviate inflammation, reduce tendon adhesions, and promote mobility recovery.

Group Type: EXPERIMENTAL

Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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 training period was supervised by a professional.

Intervention Type: 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 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zixin Deng

OTHER

Sponsor Role: lead

Responsible Party

Zixin Deng

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xin Z Deng

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xin Z Deng

Role: CONTACT

dzx_dengzixin@163.com

+8613570551532

Other Identifiers

University of Leeds

Identifier Type: -

Identifier Source: org_study_id