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

NCT ID: NCT03910101

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2024-06-25

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.

Detailed Description

Study design and participants This study used a pretest-posttest quasi-experimental design.

Study participants are recruited using two parallel procedures. I) Review of a hospital-based register of patients who had been treated or referred to the tonus clinic identified eligible patients, who were then sent information about the study, along with their contact information to the researcher responsible for the study. II) Patients with ongoing BoNT treatment who had been referred to the Center for Advanced Reconstruction of Extremities (C.A.R.E.), and were eligible for the present study were informed about the study and enrolment procedure.

All presumptive study participants will undergo a screening procedure by the primary examiner, to assess whether they met the study's eligibility criteria. Written informed consent will be obtained if the patient met the inclusion criteria and consented to participate. All patients are offered either of the two treatment methods, the treatment allocation are based on individual preferences. The study will be conducted in accordance with relevant ethical guidelines (Declaration of Helsinki).

The primary outcome measure are muscle tone, measured using the Modified Ashworth Scale (MAS). The single-item MAS was measured on a six-point scale from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with an additional point allocated at 1+ (slight increase in muscle tone). As such, the MAS provides a single score to represent spasticity in a specific movement. For analysis, the MAS scores of the treated muscles were summed to obtain a "composite spasticity score" for each participant.

Secondary outcomes includes measures within, body function, activity and Participation.

The calculation of sample size was based on the a priori defined difference to be detected, with an alpha level of 5% and a power goal of 80%, as well as the primary outcome variable MAS and previous findings. Provide a number of 14 participants in each of the two groups. We expected a dropout rate of 15%, and therefore aimed to include 17 individuals in each group to achieve 80% power.

Between-group differences and within-group differences in treatment efficacy will be analysed by comparing pretest-posttest changes.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hand surgery and intensive rehabilitation

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.

Group Type: ACTIVE_COMPARATOR

Hand surgery and intensive rehabilitation

Intervention Type: 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.

Botulinum toxin injections

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.

Group Type: ACTIVE_COMPARATOR

Hand surgery and intensive rehabilitation

Intervention Type: 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.

Interventions

Hand surgery and intensive rehabilitation

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.

Intervention Type: PROCEDURE

Other Intervention Names

Botulinum toxin injections and rehabilitation

Eligibility Criteria

Exclusion Criteria

• Under the age of 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lina Bunketorp Kall, PhD

Role: STUDY_CHAIR

University of Gothenburg, Sahlgrenska academy

Locations

Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities

Mölndal, Västra Götaland County, Sweden

Countries

Sweden

Other Identifiers

Theno1RCT

Identifier Type: -

Identifier Source: org_study_id