TGCTTGCTNCT06709911
A Comparative Study of the Efficacy of Multimodal Interventions for Tenosynovitis
A study testing Basic Manipulation Stretching, Massage and Tui Na Manipulation and Blood flow restriction training in people with TGCT, run by Zixin Deng.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- TGCT
- What is being tested?
- Basic Manipulation Stretching, Massage and Tui Na Manipulation and Blood flow restriction training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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
- Being tested
- Basic Manipulation Stretching, Massage and Tui Na Manipulation, Blood flow restriction training, Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Manipulation StretchingBehavioural
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 ManipulationBehavioural
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 trainingBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Basic Manipulation Stretching Group | Experimental | 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. Receives: Behavioral: Basic Manipulation Stretching |
| Massage and Tui Na Manipulation | Experimental | 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. Receives: Behavioral: Massage and Tui Na Manipulation |
| Blood flow restriction training group | Experimental | 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. Receives: Behavioral: Blood flow restriction training |
| Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention Group | Experimental | 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. Receives: Behavioral: Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale, VAS
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.
Measured: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
Mayo Wrist Score, MWS
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.
Measured: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
Wrist strength
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.
Measured: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
Range of Motion Measurement
Flexion and extension angle measurements, forearm pronation and pronation angle measurements
Measured: Baseline, 4 weeks, (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TGCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zixin Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zixin Deng, First People's Hospital of Foshan
- Investigators
- Xin Z Deng, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709911
- Sponsor's protocol ID
- University of Leeds
- Acronym
- TGCT
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06709911
- Acronym / sponsor ID
- TGCT / University of Leeds
- Conditions
- TGCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zixin DengUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Basic Manipulation Stretching Group | Experimental | Behavioral: Basic Manipulation StretchingFocuses 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. |
| Massage and Tui Na Manipulation | Experimental | Behavioral: Massage and Tui Na ManipulationUses 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. |
| Blood flow restriction training group | Experimental | Behavioral: Blood flow restriction trainingApplies 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. |
| Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention Group | Experimental | Behavioral: Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined InterventionCombines 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Manipulation StretchingThis 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. | Behavioural | Basic Manipulation Stretching Group |
| Massage and Tui Na ManipulationThe 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. | Behavioural | Massage and Tui Na Manipulation |
| Blood flow restriction trainingThis 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. | Behavioural | Blood flow restriction training group |
| Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined InterventionThis 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. | Behavioural | Magnetic Bead Pressure Stimulation and Tui Na Manipulation Combined Intervention Group |
Primary outcome
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Z Deng principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Basic Manipulation Stretching, Massage and Tui Na Manipulation and Blood flow restriction training in people with TGCT, run by Zixin Deng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Z Deng (+8613570551532, dzx_dengzixin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale, VAS (time frame: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.