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RecruitingNCT07347028Updated Oct 8, 2026

Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)

An interventional study of MTrPs Injection and Intra-articular(IA) Injection in Myofascial Trigger Points, Migraine and Cervicogenic Headache, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Updated Oct 8, 2026Start date movedStudy completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

Chronic musculoskeletal pain (CMP) is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Knee osteoarthritis is a common type of CMP. Currently, both domestic and international studies have confirmed that glucocorticoid injection at myofascial trigger points(MTrPs) can alleviate patients' pain symptoms. MTrPs injection is safe and easy to operate, and can improve the clinical management efficiency of patients with knee osteoarthritis. Therefore, we designed a prospective, randomized controlled, blinded outcome, non-inferiority study to compare the long-term clinical efficacy of glucocorticoid injection at myofascial trigger points and complex intra-articular injection in treating knee osteoarthritis. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or joint cavities. After treatment, patients will be followed up for 2 years. Their NRS scores, WOMAC scores, Patient Global Impression of Change(PGIC) scale, and adverse reactions will be recorded at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. If the results indicate that the clinical efficacy of myofascial trigger point injection for knee osteoarthritis is not inferior to that of injection at intra-articular injection, it will provide a safe and simple treatment option that is easy to promote for patients who do not respond to conservative treatment.

02

Conditions studied

  • Myofascial Trigger Points
  • Migraine
  • Cervicogenic Headache
  • Chronic Musculoskeletal Pain
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 238 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of knee osteoarthritis with radiographic evidence of osteoarthritis (Kellgren-Lawrence grade 1-4) confirmed by at least two orthopedic surgeons, pain specialists, or general practitioners, with physical examination confirming at least one myofascial trigger point;
  • Disease duration exceeding 3 months;
  • Age ≥ 45 years;
  • Numerical Rating Scale (NRS) score ≥ 3 points despite prior conservative pharmacological treatment;
  • Signed form.

Exclusion criteria

Exclusion Criteria:

  • History of allergy to trial medications such as ;
  • Alcohol abuse; long-term use of opioids (exceeding 2 weeks or more than 3 days per week for over 1 month); suspected use of sedative or analgesic medications; patients on long-term steroid therapy;
  • Severe neurological disorders, significant hepatic or renal dysfunction, heart failure, coagulation abnormalities, gastric ulcer, diabetes, inflammatory rheumatic diseases, etc.;
  • Intra-articular injection within the past 6 months or planned joint replacement surgery;
  • Inability to use pain assessment scales;
  • Presence of local or systemic infection;
  • Pregnant or lactating patients.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
238 participants (estimated)

Study arms

  • Active comparator
    Joint cavity injection group

    Joint cavity injection with triamcinolone acetonide

    Procedure: Intra-articular(IA) Injection

  • Experimental
    MTrPs injection group

    MTrPs injection with triamcinolone acetonide.

    Procedure: MTrPs Injection

Interventions

  • ProcedureMTrPs Injection

    Each MTrP is identified by palpation, no more than 10 of the most painful MTrPS are selected for injection. Prior to treatment, the assessed MTrPs are marked with a permanent marker. Each MTrP receiving 1 mL of injection volume. The injection solution is prepared with normal saline, lidocaine and 0.5 ml TA (40mg/ml) to the volume required for treatment. A 25-gauge needle is used to inject perpendicular to the skin surface at the selected MTrPs, with the solution administered as a single bolus into each MTrP within 10 seconds.

  • ProcedureIntra-articular(IA) Injection

    Patients in the IA injection group will receive an IA knee injection via an anterolateral approach. The injection solution is prepared using 0.5 mL of 1% lidocaine and 0.5 mL of TA (40 mg/mL). The IA injection will be performed under ultrasound guidance to guarantee and reduce the incidence of bleeding or infection.

06

What researchers measure

Primary outcomes

  1. the change from baseline in the WOMAC score

    The WOMAC assesses pain, stiffness, and physical function, with higher scores indicating more severe symptoms and greater functional limitation.

    Time frame: at the 4-weeks

Secondary outcomes

  1. the change from baseline in the WOMAC scores

    The WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) is a standardized instrument specifically designed to assess symptoms and function in patients with knee/hip osteoarthritis. It comprises three dimensions with a total of 24 items: pain (5 items), stiffness (2 items), and physical function in daily activities (17 items). It utilizes a Likert scale (0-4 points, 0 = no symptoms), with a total score range of 0-96 points (or standardized to 0-100 points). Higher scores indicate greater functional impairment.

    Time frame: at the weeks 2, 4, 8, 12, and 24

  2. NRS pain scores

    The pain intensity of the knee will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

    Time frame: At the weeks 2, 4, 8, 12 and 24

  3. The Patient Global Impression of Change (PGIC) scale

    The Patient Global Impression of Change (PGIC) scale is a patient-rated instrument used to evaluate overall change in status following treatment. It employs a 7-point Likert scale (1 = "very much worse" to 7 = "very much improved"), focusing on the patient's subjective perception of symptoms, function, and quality of life. The evaluation criterion defines a score of 5 or higher as indicative of "improvement" (mild/moderate/marked), a score of 4 as "no change," and scores of 3 or below as "worsening."

    Time frame: at the weeks 2, 4, 8, 12, and 24

  4. Knee performance

    including nee flexion, extension deficit, maximal flexion, and total range of motion

    Time frame: at baseline and at the weeks 4, 12, and 24

  5. Myofascial outcomes

    including the number of active myofascial trigger points, pressure pain thresholds at predefined trigger-point sites, pain intensity during standardized palpation, and reproduction of the participant's usual knee pain

    Time frame: at baseline and at the weeks 4, 12, and 24

  6. Health-related quality of life

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).

    Time frame: at baseline and the weeks 4, 12, and 24

  7. Rescue analgesic consumption, additional knee-related treatments, unscheduled medical visits, and clinically relevant pain recurrence

    Rescue analgesic consumption, additional knee-related treatments, unscheduled medical visits, and clinically relevant pain recurrence

    Time frame: throughout the 24-week follow-up period

  8. Adverse Reactions

    Any systemic adverse reactions related to corticosteroids such as hyperglycemic reactions, infection at the puncture site, and intra-articular infection.

    Time frame: throughout the 24-week follow-up period.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Dec 1, 2025→Oct 1, 2025
Oct 8, 2026
Study completion
Jun 1, 2027→Jan 1, 2027
Oct 8, 2026
Enrollment
1036→238
Oct 8, 2026
Interventions
Added Procedure: Intra-articular(IA) Injection; removed Procedure: Joint Cavity Injection
Oct 8, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore NRS pain scoresNow the change from baseline in the WOMAC scoreTime frame: at the 4-weeks
Oct 8, 2026
Secondary outcomes
1 edited, 1 time frame changed, 4 added
What changed in the outcomes
  • ChangedBefore WOMAC scoresNow the change from baseline in the WOMAC scoresTime frame: at the weeks 2, 4, 8, 12, and 24
  • AddedKnee performanceTime frame: at baseline and at the weeks 4, 12, and 24
  • AddedMyofascial outcomesTime frame: at baseline and at the weeks 4, 12, and 24
  • AddedHealth-related quality of lifeTime frame: at baseline and the weeks 4, 12, and 24
  • AddedRescue analgesic consumption, additional knee-related treatments, unscheduled medical visits, and clinically relevant pain recurrenceTime frame: throughout the 24-week follow-up period
  • Time frameAdverse ReactionsThrough study completion, an average of 1 year → throughout the 24-week follow-up period.
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Start date Dec 1, 2025→Oct 1, 2025
    Study completion Jun 1, 2027→Jan 1, 2027
    Enrollment 1036→238
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore NRS pain scoresNow the change from baseline in the WOMAC scoreTime frame: at the 4-weeks
    Secondary outcomes 1 edited, 1 time frame changed, 4 added
    What changed in the outcomes
    • ChangedBefore WOMAC scoresNow the change from baseline in the WOMAC scoresTime frame: at the weeks 2, 4, 8, 12, and 24
    • AddedKnee performanceTime frame: at baseline and at the weeks 4, 12, and 24
    • AddedMyofascial outcomesTime frame: at baseline and at the weeks 4, 12, and 24
    • AddedHealth-related quality of lifeTime frame: at baseline and the weeks 4, 12, and 24
    • AddedRescue analgesic consumption, additional knee-related treatments, unscheduled medical visits, and clinically relevant pain recurrenceTime frame: throughout the 24-week follow-up period
    • Time frameAdverse ReactionsThrough study completion, an average of 1 year → throughout the 24-week follow-up period.
    Interventions Added Procedure: Intra-articular(IA) Injection; removed Procedure: Joint Cavity Injection
    + 4 other changes: index terms, verification date, responsible party and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07347028
Collaborators
Renmin Hospital of Wuhan University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Nanchang University, Beijing Aerospace General Hospital, Beijing Jianjia Rehabilitation Hospital, Yangyuan Youyi Hospital
Responsible party
Fang Luo (Director, Department of Pain Management, Principal Investigator, Clinical Professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Jan 16, 2026
Start date
Oct 1, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Fang Luo
Contact
13611326978@163.com
+86 13611326978

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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