True Versus Sham Thread Embedding Acupuncture for Spasticity-Related Symptoms and Disabilities in Multiple Sclerosis: Study Protocol
This publication outlines a study protocol for a randomized, sham-controlled trial involving 38 participants with multiple sclerosis and moderate-to-severe spasticity. The study aims to evaluate the effects of True TEA compared to Sham TEA, focusing on disability changes as the primary endpoint, with assessments at 4 and 12 weeks post-intervention.
- Tags
- #MSResearch
- Most relevant to
- —
- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- Moderate
- Outcome
- Not reported
Why it matters
This study protocol is essential for understanding how effective True TEA may be in managing spasticity in people with MS, which can significantly impact their quality of life. However, results from this trial are currently unavailable.
What this does not prove
This is a protocol publication, and actual findings from the trial are not yet available.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 38 · basis not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- 2026-10-15
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- PwMS with moderate-to-severe spasticity
- Size of effect
- Not reported
- Secondary endpoints
- Numeric Rating Scale for Spasticity (NRS-S); walking ability (MSWS-12); activities of daily living (Barthel Index); pain (McGill Pain Questionnaire); fatigue (MFIS); sleep quality (PSQI); urinary symptoms (ABSST); mood (HADS); quality of life (EQ-5D-5L); overall treatment satisfaction
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
- Primary evidenceTrue Versus Sham Thread Embedding Acupuncture for Spasticity-Related Symptoms and Disabilities in Multiple Sclerosis: Study Protocol of a Randomized Controlled Trial. ↗DOI: 10.3390/healthcare14203467
Supporting passages (14)
study phaseThis is a protocol of a randomized, sham-controlled, patient-, assessor- and analyst-blinded, superiority clinical trial.
study designThis is a protocol of a randomized, sham-controlled, patient-, assessor- and analyst-blinded, superiority clinical trial.
subjectsThirty-eight eligible PwMS with moderate-to-severe spasticity will be randomized 1:1 to either TTEA or STEA.
sample sizeThirty-eight eligible PwMS with moderate-to-severe spasticity will be randomized 1:1 to either TTEA or STEA.
randomizedThirty-eight eligible PwMS with moderate-to-severe spasticity will be randomized 1:1 to either TTEA or STEA.
controlledThis is a protocol of a randomized, sham-controlled, patient-, assessor- and analyst-blinded, superiority clinical trial.
primary endpointThe primary outcome is change in disability (EDSS).
follow upAssessments will be conducted at baseline, 4 weeks, and 12 weeks post-intervention.
findingsThis is a study that protocol aims to evaluate the efficacy and safety of True TEA (TTEA) compared with Sham TEA (STEA) in reducing spasticity and improving mobility and related symptoms among PwMS.
populationThirty-eight eligible PwMS with moderate-to-severe spasticity will be randomized 1:1 to either TTEA or STEA.
secondary endpointsSecondary outcomes are Numeric Rating Scale for Spasticity (NRS-S), walking ability (MSWS-12), activities of daily living (Barthel Index), pain (McGill Pain Questionnaire), fatigue (MFIS), sleep quality (PSQI), urinary symptoms (ABSST), mood (HADS), quality of life (EQ-5D-5L), overall treatment satisfaction, willingness to repeat and recommendation to others.
publication datePublication date: 2026-10-15
limitationsTitle: True Versus Sham Thread Embedding Acupuncture for Spasticity-Related Symptoms and Disabilities in Multiple Sclerosis: Study Protocol of a Randomized Controlled Trial.
peer reviewedPublication types: Journal Article
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