Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment

NCT03910101 | Completed

• 1 other identifier: Theno1RCT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity - a variety of motor over-activity and part of the upper motor neuron syndrome - is a common cause of impaired motor function after brain injuries of different etiologies. In addition, it may cause pain and impaired hygiene, contractures, deformities etc. Spasticity has been reported in 30 to 90% of patients with stroke, traumatic brain injury (TBI), incomplete spinal cord injury (SCI) and cerebral palsy (CP). Spasticity therapy has emerged as an important approach to alleviate related symptoms. Positive effects on spasticity are well recognized following systemic and intra-thecal pharmacological treatment, as well as after intra-muscularly injected substances; the effect of the latter is, however, of limited duration. While pharmacological spasticity therapy has been applied for decades, surgical procedures remain fairly uncommon in adults with spasticity, but not in pediatric patients with CP, and outcomes after surgical treatment are scarcely described in the literature. The study center is a specialized unit initially focused on reconstructive as well as spasticity reducing surgery in the upper extremities for SCI patients. Subsequently, patients with spasticity also due to various other Central nervous system diseases have been referred to the center for surgical treatment. Studies describing the effect of spasticity-reducing surgery in the upper extremities are rare and the group is heterogeneous. The aim of the study is evaluating the long-term efficacy of spasticity-correcting surgery versus BoNT in patients with disabling UL spasticity. As a secondary aim, we want to compare the peak effects of the two treatments, Botulinum toxin injections and spasticity-correcting surgery.

Conditions

Spasticity, Muscle; Spinal Cord Injuries; Traumatic Brain Injury; Stroke; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (1)

• Change is being assessed with Modified Ashworth Scale

  0-5 scale that quantify the degree of resistance to passive movement of the target muscle group

  Change from baseline and at the the time points 4-6weeks and 6months

Secondary Outcomes (10)

• Change is being assessed with Visual Analog scale (VAS)

  Change from baseline and at the the time points 4-6weeks and 6months

• Change is being assessed with goniometry

  Change from baseline and at the the time points 4-6weeks and 6months

• Change is being assessed with Jamar dynamometer

  Change from baseline and at the the time points 4-6weeks and 6months

• Change is being assessed with pinch gauge

  Change from baseline and at the the time points 4-6weeks and 6months

• Change is being assessed with opening of the hand passive, Active and resting position

  Change from baseline and at the the time points 4-6weeks and 6months

Study Arms (2)

Hand surgery and intensive rehabilitation

ACTIVE COMPARATOR

The surgical treatment for reducing spasticity comprises lengthening of tendons, muscle release and occasionally correction of deformities. Lengthening of a tendon or releasing a muscle from its insertion, results in relaxation of the whole muscle-tendon unit. Hence, the spasticity is not gone, but reduced in strength. The tendon lengthening procedures is performed by a stair-step incision technique followed by reattachment in the lengthened position using a side-to-side, cross-stich technique. The load to failure of the sutured tendon is approximately 200Newton, which gives a sufficient safety margin for early active mobilization of the tendons involved. This suture technique thus enables active training directly after surgery. Postoperative rehabilitation includes wrapping and a custom-made splint, for day and night use, muscle activation and passive stretching 2-4 times per day without the splint.

Procedure: Hand surgery and intensive rehabilitation

Botulinum toxin injections

ACTIVE COMPARATOR

Botulinum toxin injections are given in spastic muscles of the upper extremity. Dosage and number of injections per muscle vary depending on the degree and extent of spasticity. For optimal effect on hand function, botulinum toxin is accompanied by the treatment of individualized exercise and splinting when needed.

Procedure: Hand surgery and intensive rehabilitation

Interventions

Hand surgery and intensive rehabilitation PROCEDURE

Spasticity-correcting upper-limb surgery comprised lengthening of tendons, release of muscles, and occasionally correction of deformities. Rehabilitation starts the first post-operative day and comprised physiotherapy and occupational therapy. Patients are also taught a home-training program. Up to 1 week of intensive in-hospital rehabilitation followed 3 weeks after surgery and a new home-training program are designed.

Also known as: Botulinum toxin injections and rehabilitation

Botulinum toxin injections; Hand surgery and intensive rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Under the age of 18

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities

Mölndal, Västra Götaland County, 431 30, Sweden

Location

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries; Brain Injuries, Traumatic; Stroke; Paresis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Brain Diseases; Craniocerebral Trauma; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lina Bunketorp Kall, PhD

  University of Gothenburg, Sahlgrenska academy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: April 10, 2019
• Study Start: January 25, 2019
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)