Tendon-lengthening surgery versus botulinum toxin injections for hand and wrist spasticity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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:

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Where it's running

• Sahlgrenska University Hoispital
  Mölndal, Sweden Recruiting

Study contacts

• Study coordinator: Therese Ramström, PhD
• Email: therese.ramstrom@vgregion.se
• Phone: +46(0)761357416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.