Tendon AdhesionNCT07184658
Ultrasound-Guided Multiple Saline Injections for Prevention of Tendon Adhesion: A Randomized Controlled Trial
A study testing Ultrasound-guided peritendinous saline injection in people with Tendon Adhesion, run by Kai Wang at 1 site in China.
Trial summary
This prospective randomized controlled trial aims to evaluate the efficacy and safety of ultrasound-guided repeated normal saline injections for the prevention and treatment of tendon adhesion following flexor tendon repair. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tendon Adhesion
- What is being tested?
- Ultrasound-guided peritendinous saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age between 18 and 60 years. Diagnosed with flexor tendon rupture. Scheduled for surgical tendon repair.
Who cannot join
- Associated vascular or nerve injury. History of diabetes mellitus. History of non-steroidal anti-inflammatory drug (NSAID) treatment. History of cardiac insufficiency. History of hematologic diseases. History of hepatic or renal dysfunction. History of rheumatologic or autoimmune diseases. History of radiotherapy or chemotherapy. History of corticosteroid treatment. Pregnancy. Currently participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Prospective Randomized Controlled Trial of Ultrasound-Guided Repeated Normal Saline Injections for Preventing and Treating Tendon Adhesion
This prospective randomized controlled trial aims to evaluate the efficacy and safety of ultrasound-guided repeated normal saline injections for the prevention and treatment of tendon adhesion following flexor tendon repair. Tendon adhesion is a common complication after tendon injury, leading to pain, stiffness, and impaired hand function. Conventional anti-adhesion strategies, such as physical barrier membranes, may induce local inflammation or have limited effectiveness.
In this study, patients undergoing tendon repair will be randomly assigned to receive either ultrasound-guided peritendinous saline injections at 7, 14, and 21 days after surgery (intervention group) or no injection (control group). The primary outcome is total active motion (TAM-%) at 3 months after surgery. Secondary outcomes include TAM-% at 6 weeks, pain scores (VAS), Michigan Hand Questionnaire (MHQ) scores, infection rate, and tendon rupture rate. A total of 136 patients will be enrolled (68 in each group).
The findings of this trial will help to establish whether repeated saline injections under ultrasound guidance can effectively prevent tendon adhesion, improve pain and functional outcomes, and ensure tendon healing with minimal complications.
Read the detailed description
Tendon adhesion is one of the most common complications following flexor tendon repair, with an incidence of up to 60%. Adhesion significantly impairs hand function, often leading to a cycle of adhesion formation, surgical release, and recurrent adhesion, which causes long-term disability and high healthcare costs. Current preventive measures mainly rely on physical barrier materials, such as membranes or gels, but these approaches may induce aseptic inflammation and pain, and their long-term effectiveness remains limited.
Our previous research suggested that early peritendinous injection therapy may be more effective than intraoperative application in preventing tendon adhesion. Using dynamic ultrasound, we successfully localized tendon adhesion sites and demonstrated the feasibility of delivering precise peritendinous injections under ultrasound guidance. Based on these findings, we hypothesize that repeated ultrasound-guided saline injections at early postoperative stages can reduce adhesion formation while minimizing the impact on tendon healing.
This is a prospective, single-center, randomized controlled clinical trial enrolling 136 patients (68 per group) after flexor tendon repair. Patients in the intervention group will undergo ultrasound-guided peritendinous injections of 1 mL normal saline on postoperative days 7, 14, and 21. The control group will receive standard care without injections. Patients will be followed up at 6 weeks and 3 months after surgery. The primary endpoint is total active motion (TAM-%) at 3 months. Secondary endpoints include TAM-% at 6 weeks, visual analog scale (VAS) pain scores, Michigan Hand Questionnaire (MHQ) scores, infection rate, tendon rupture rate, and wound healing time.
Safety will be assessed through physical examinations, laboratory tests (blood count, C-reactive protein, erythrocyte sedimentation rate), and adverse event monitoring. Statistical analysis will be performed using appropriate parametric or non-parametric methods, with significance set at P < 0.05.
The successful completion of this study is expected to provide clinical evidence supporting ultrasound-guided saline injections as a safe, effective, and low-cost strategy for preventing tendon adhesion, improving hand function, and reducing complications.
- Conditions
- Tendon Adhesion
- Being tested
- Ultrasound-guided peritendinous saline injection
- Keywords
- Ultrasound-guided injection, Normal saline, Tendon adhesion prevention, Flexor tendon repair, Hand surgery, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided peritendinous saline injectionProcedure or surgery
Also called Normal saline injection
Under ultrasound guidance, 1 mL of sterile normal saline will be injected peritendinously at the tendon repair site at 7, 14, and 21 days after surgery to reduce adhesion formation and preserve tendon healing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Ultrasound-guided Saline Injection | Experimental | Patients will undergo ultrasound-guided peritendinous injections of 1 mL normal saline at the tendon repair site on postoperative days 7, 14, and 21. The goal is to prevent tendon adhesion and improve functional outcomes. Receives: Procedure: Ultrasound-guided peritendinous saline injection |
| Control Group - Standard Care | No intervention | Patients will receive standard postoperative care after tendon repair without saline injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Active Motion Percentage (TAM-%) of the injured finger at 3 months after surgery
TAM-% is calculated as the sum of active flexion at the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints minus the sum of extension deficits, divided by the normal range of motion, multiplied by 100%. It reflects functional recovery and tendon adhesion severity.
Measured: 3 months after tendon repair
Secondary outcomes (5)
Pain score (VAS)
Visual Analog Scale (0-10), where 0 = no pain and 10 = worst imaginable pain.
Measured: 6 weeks and 3 months after surgery
TAM-% at 6 weeks after surgery
Same calculation method as the primary outcome, evaluated at an earlier time point.
Measured: 6 weeks after tendon repair
Michigan Hand Questionnaire (MHQ) score
Patient-reported outcome measure assessing hand function, activities of daily living, pain, work performance, aesthetics, and satisfaction.
Measured: 3 months after surgery
Tendon rupture rate
Incidence of tendon rupture confirmed by clinical examination or imaging.
Measured: Within 3 months after surgery
Infection rate
Incidence of superficial or deep surgical site infections diagnosed according to clinical and laboratory criteria.
Measured: Within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Sep 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tendon AdhesionStudies 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
- Parallel groups
- Model description
- This is a prospective, single-center, randomized controlled trial with parallel assignment. Patients undergoing flexor tendon repair will be randomly allocated to either the intervention group (ultrasound-guided saline injections) or the control group (no injection).
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kai Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Wang, Shanghai 6th People's Hospital
- Investigators
- Shen LIU, MD, Principal investigator, Shanghai 6th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184658
- Sponsor's protocol ID
- 2025-119
- Other IDs
- 82425035
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared due to concerns regarding patient privacy and institutional regulations.
Publications
Franssen AJPM, Degens JHRJ, Daemen JHT, Laven IEWG, Hulsewe KWE, Vissers YLJ, de Loos ER. Mediastinal staging by thoracic surgeons: are we close to a paradigm shift? J Thorac Dis. 2023 Jan 31;15(1):10-13. doi: 10.21037/jtd-22-1420. Epub 2023 Jan 6. No abstract available.
PubMed 36794129Ockun MA, Gercek YC, Demirsoy H, Demirsoy L, Macit I, Oz GC. Comparative evaluation of phenolic profile and antioxidant activity of new sweet cherry (Prunus avium L.) genotypes in Turkey. Phytochem Anal. 2022 Jun;33(4):564-576. doi: 10.1002/pca.3110. Epub 2022 Feb 4.
PubMed 35122339Yasmeen R, Zahid B, Alyas S, Akhtar R, Zahra N, Kouser S, Hashmi AS, Athar M, Tayyab M, Anjum AA. Ameliorative effects of Lactobacillus against Aflatoxin B1. Braz J Biol. 2021 Dec 20;84:e250517. doi: 10.1590/1519-6984.250517. eCollection 2021.
PubMed 34932626Sueiras M, Sahuquillo J, Garcia-Lopez B, Sanchez-Guerrero A, Poca MA, Santamarina E, Riveiro M, Fabricius M, Strong AJ. [Cortical spreading depolarization phenomena in patients with traumatic and ischemic brain injuries. Results of a pilot study]. Med Intensiva. 2014 Oct;38(7):413-21. doi: 10.1016/j.medin.2013.09.008. Epub 2013 Dec 15. Spanish.
PubMed 24342071Roy V, Sahni P, Gupta P, Sethi GR, Khanna A. Blood levels of pyrazinamide in children at doses administered under the Revised National Tuberculosis Control Program. Indian Pediatr. 2012 Sep;49(9):721-5. doi: 10.1007/s13312-012-0164-8. Epub 2011 Jan 17.
PubMed 22317983Kim HT, Oh JS, Lee JS, Lee TH. Z-lengthening of the Achilles tendon with transverse skin incision. Clin Orthop Surg. 2014 Jun;6(2):208-15. doi: 10.4055/cios.2014.6.2.208. Epub 2014 May 16.
PubMed 24900904
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Ultrasound-Guided Repeated Normal Saline Injections for Preventing and Treating Tendon Adhesion
- ClinicalTrials.gov ID
- NCT07184658
- Acronym / sponsor ID
- 2025-119
- Conditions
- Tendon Adhesion
- Keywords
- Ultrasound-guided injection, Normal saline, Tendon adhesion prevention, Flexor tendon repair, Hand surgery, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kai WangUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 22 Sep 2025 (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.
This prospective randomized controlled trial aims to evaluate the efficacy and safety of ultrasound-guided repeated normal saline injections for the prevention and treatment of tendon adhesion following flexor tendon repair. Tendon adhesion is a common complication after tendon injury, leading to pain, stiffness, and impaired hand function. Conventional anti-adhesion strategies, such as physical barrier membranes, may induce local inflammation or have limited effectiveness.
In this study, patients undergoing tendon repair will be randomly assigned to receive either ultrasound-guided peritendinous saline injections at 7, 14, and 21 days after surgery (intervention group) or no injection (control group). The primary outcome is total active motion (TAM-%) at 3 months after surgery. Secondary outcomes include TAM-% at 6 weeks, pain scores (VAS), Michigan Hand Questionnaire (MHQ) scores, infection rate, and tendon rupture rate. A total of 136 patients will be enrolled (68 in each group).
The findings of this trial will help to establish whether repeated saline injections under ultrasound guidance can effectively prevent tendon adhesion, improve pain and functional outcomes, and ensure tendon healing with minimal complications.
Detailed description
Tendon adhesion is one of the most common complications following flexor tendon repair, with an incidence of up to 60%. Adhesion significantly impairs hand function, often leading to a cycle of adhesion formation, surgical release, and recurrent adhesion, which causes long-term disability and high healthcare costs. Current preventive measures mainly rely on physical barrier materials, such as membranes or gels, but these approaches may induce aseptic inflammation and pain, and their long-term effectiveness remains limited.
Our previous research suggested that early peritendinous injection therapy may be more effective than intraoperative application in preventing tendon adhesion. Using dynamic ultrasound, we successfully localized tendon adhesion sites and demonstrated the feasibility of delivering precise peritendinous injections under ultrasound guidance. Based on these findings, we hypothesize that repeated ultrasound-guided saline injections at early postoperative stages can reduce adhesion formation while minimizing the impact on tendon healing.
This is a prospective, single-center, randomized controlled clinical trial enrolling 136 patients (68 per group) after flexor tendon repair. Patients in the intervention group will undergo ultrasound-guided peritendinous injections of 1 mL normal saline on postoperative days 7, 14, and 21. The control group will receive standard care without injections. Patients will be followed up at 6 weeks and 3 months after surgery. The primary endpoint is total active motion (TAM-%) at 3 months. Secondary endpoints include TAM-% at 6 weeks, visual analog scale (VAS) pain scores, Michigan Hand Questionnaire (MHQ) scores, infection rate, tendon rupture rate, and wound healing time.
Safety will be assessed through physical examinations, laboratory tests (blood count, C-reactive protein, erythrocyte sedimentation rate), and adverse event monitoring. Statistical analysis will be performed using appropriate parametric or non-parametric methods, with significance set at P < 0.05.
The successful completion of this study is expected to provide clinical evidence supporting ultrasound-guided saline injections as a safe, effective, and low-cost strategy for preventing tendon adhesion, improving hand function, and reducing complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, single-center, randomized controlled trial with parallel assignment. Patients undergoing flexor tendon repair will be randomly allocated to either the intervention group (ultrasound-guided saline injections) or the control group (no injection).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Ultrasound-guided Saline Injection | Experimental | Procedure: Ultrasound-guided peritendinous saline injectionPatients will undergo ultrasound-guided peritendinous injections of 1 mL normal saline at the tendon repair site on postoperative days 7, 14, and 21. The goal is to prevent tendon adhesion and improve functional outcomes. |
| Control Group - Standard Care | No intervention | –Patients will receive standard postoperative care after tendon repair without saline injection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18 and 60 years. Diagnosed with flexor tendon rupture. Scheduled for surgical tendon repair.
Key exclusion criteria (1 listed)
- Associated vascular or nerve injury. History of diabetes mellitus. History of non-steroidal anti-inflammatory drug (NSAID) treatment. History of cardiac insufficiency. History of hematologic diseases. History of hepatic or renal dysfunction. History of rheumatologic or autoimmune diseases. History of radiotherapy or chemotherapy. History of corticosteroid treatment. Pregnancy. Currently participating in another clinical trial.
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 |
|---|---|---|
| Ultrasound-guided peritendinous saline injectionAlso: Normal saline injectionUnder ultrasound guidance, 1 mL of sterile normal saline will be injected peritendinously at the tendon repair site at 7, 14, and 21 days after surgery to reduce adhesion formation and preserve tendon healing. | Procedure or surgery | Intervention Group - Ultrasound-guided Saline Injection |
Primary outcome
Total Active Motion Percentage (TAM-%) of the injured finger at 3 months after surgery
Time frame: 3 months after tendon repair
TAM-% is calculated as the sum of active flexion at the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints minus the sum of extension deficits, divided by the normal range of motion, multiplied by 100%. It reflects functional recovery and tendon adhesion severity.
5 secondary outcomes
Pain score (VAS)
Time frame: 6 weeks and 3 months after surgery
TAM-% at 6 weeks after surgery
Time frame: 6 weeks after tendon repair
Michigan Hand Questionnaire (MHQ) score
Time frame: 3 months after surgery
Tendon rupture rate
Time frame: Within 3 months after surgery
Infection rate
Time frame: Within 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 36794129Franssen AJPM, Degens JHRJ, Daemen JHT, Laven IEWG, Hulsewe KWE, Vissers YLJ, de Loos ER. Mediastinal staging by thoracic surgeons: are we close to a paradigm shift? J Thorac Dis. 2023 Jan 31;15(1):10-13. doi: 10.21037/jtd-22-1420. Epub 2023 Jan 6. No abstract available.
- Background: PubMed 35122339Ockun MA, Gercek YC, Demirsoy H, Demirsoy L, Macit I, Oz GC. Comparative evaluation of phenolic profile and antioxidant activity of new sweet cherry (Prunus avium L.) genotypes in Turkey. Phytochem Anal. 2022 Jun;33(4):564-576. doi: 10.1002/pca.3110. Epub 2022 Feb 4.
- Background: PubMed 34932626Yasmeen R, Zahid B, Alyas S, Akhtar R, Zahra N, Kouser S, Hashmi AS, Athar M, Tayyab M, Anjum AA. Ameliorative effects of Lactobacillus against Aflatoxin B1. Braz J Biol. 2021 Dec 20;84:e250517. doi: 10.1590/1519-6984.250517. eCollection 2021.
- Background: PubMed 24342071Sueiras M, Sahuquillo J, Garcia-Lopez B, Sanchez-Guerrero A, Poca MA, Santamarina E, Riveiro M, Fabricius M, Strong AJ. [Cortical spreading depolarization phenomena in patients with traumatic and ischemic brain injuries. Results of a pilot study]. Med Intensiva. 2014 Oct;38(7):413-21. doi: 10.1016/j.medin.2013.09.008. Epub 2013 Dec 15. Spanish.
- Background: PubMed 22317983Roy V, Sahni P, Gupta P, Sethi GR, Khanna A. Blood levels of pyrazinamide in children at doses administered under the Revised National Tuberculosis Control Program. Indian Pediatr. 2012 Sep;49(9):721-5. doi: 10.1007/s13312-012-0164-8. Epub 2011 Jan 17.
- Background: PubMed 24900904Kim HT, Oh JS, Lee JS, Lee TH. Z-lengthening of the Achilles tendon with transverse skin incision. Clin Orthop Surg. 2014 Jun;6(2):208-15. doi: 10.4055/cios.2014.6.2.208. Epub 2014 May 16.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared due to concerns regarding patient privacy and institutional regulations.
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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. This study is not recruiting at the moment.
Shen LIU, MD principal investigator
Shanghai 6th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided peritendinous saline injection in people with Tendon Adhesion, run by Kai Wang at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Active Motion Percentage (TAM-%) of the injured finger at 3 months after surgery (time frame: 3 months after tendon repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07184658, which also lists 6 linked publications.
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 30 Apr 2026.