Tendon-lengthening surgery versus botulinum toxin injections for hand and wrist spasticity
The Effectiveness of Spasticity-correcting Upper Limb Surgery Versus Botulinum Toxin Injections in Patients With Upper Limb Spasticity: an Experimental Study With Paired Design
This project tries to see if tendon-lengthening surgery helps adults with hand and wrist spasticity after stroke, spinal cord injury, or traumatic brain injury more than ongoing botulinum toxin injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Mölndal) |
| Trial ID | NCT06733025 on ClinicalTrials.gov |
What this trial studies
This open-label, non-randomized paired-design study at Sahlgrenska University Hospital compares tendon lengthening surgery to ongoing botulinum toxin (BoNT) injections for upper-limb spasticity affecting hand and wrist function. Eligible adults are at least six months post-injury (stroke, TBI, or SCI), currently receiving BoNT with at least three months since their last injection, and have at least two hand/wrist muscles considered for treatment. Participants either undergo tendon-lengthening surgery with standard postoperative care or continue BoNT injections combined with community therapy, and outcomes focus on hand function, activities of daily living, and longer-term spasticity control. The team uses a stratified surgical algorithm based on residual motor function and follows patients over time to compare durable functional benefits.
Who should consider this trial
Good fit: Adults (18+) with problematic upper-limb spasticity after stroke, TBI, or spinal cord injury who have been on BoNT treatment for the hand/wrist, are at least six months post-injury, and are medically stable for surgery are ideal candidates.
Not a fit: Patients with recent injury under six months, fewer than two affected hand/wrist muscles, major concurrent upper-limb injuries, or who are not medically fit for surgery may not benefit from or be eligible for the surgical arm.
Why it matters
Potential benefit: If successful, surgery could provide longer-lasting improvement in hand function and independence compared with repeated BoNT injections.
How similar studies have performed: Surgical approaches for focal upper-limb spasticity have shown promising long-term results in case series, but there are few high-quality comparative trials directly contrasting surgery with BoNT.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years or above 2. Problematic spasticity, characterised by a velocity-dependent increase in tonic stretch reflexes or intermittent or sustained involuntary muscle activity in the UL after stroke, TBI, or SCI 3. Patients treated at least 6 months after the injury event 4. Ongoing BoNT treatment in the UL 5. A minimum of 3 months passed since the last BoNT injection 6. At least two muscles in the hand and wrist were considered for treatment 7. For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment 8. For the surgery group, medically stable to undergo surgery 9. No other severe UL injuries affecting the functional level Exclusion Criteria: \-
Where this trial is running
Mölndal
- Sahlgrenska University Hoispital — Mölndal, Sweden (Recruiting)
Study contacts
- Study coordinator: Therese Ramström, PhD
- Email: therese.ramstrom@vgregion.se
- Phone: +46(0)761357416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.