Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction (NA-CONTROL)

This study evaluates the effect of a specific, multidisciplinary and personalized rehabilitation program compared to usual care, on motor control and functional disability in patients with neuralgic amyotrophy.

Half of the participants will start with the 17-week specific rehabilitation program while the other half will first continue their usual care for 17 weeks, after which they will also receive the 17-week specific rehabilitation program.

Study Overview

• Status: Completed
• Conditions: Parsonage Turner Syndrome; Neuralgic Amyotrophy; Neuralgic Amyotrophy, Hereditary; Brachial Neuritis
• Intervention / Treatment: Behavioral: Specific rehabilitation program; Other: Usual Care

Detailed Description

Neuralgic amyotrophy (NA) is a common (incidence 1:1000) peripheral nervous system disorder caused by acute autoimmune inflammation of the brachial plexus, the nerve bundle going to the shoulder and arm. Many NA patients develop abnormal motor control of the shoulder region (i.e. scapular dyskinesia), which persists even after the peripheral nerve damage has recovered. This suggests that persistent scapular dyskinesia in NA may result from (mal)adaptive changes in the central motor system.

Clinical experience shows that the specific, multidisciplinary and personalized rehabilitation program, focused on cognitive motor control can restore scapular dyskinesia in NA patients. This indicates that impairments in the central motor system likely play a role in persistent scapular dyskinesia and that specific rehabilitation may restore any alterations in central motor control.

We hypothesize that the specific rehabilitation program, focused on cognitive motor control is more effective in improving functional disability than usual care and that it can reverse maladaptive changes in central motor control.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (Suspected) diagnosis of neuralgic amyotrophy
• In subacute or chronic phase of neuralgic amyotrophy (>2 months after attack onset)
• Right-handed
• Neuralgic amyotrophy predominantly present in right upper extremity
• Presence of scapular dyskinesia

Exclusion Criteria:

• Patients in the acute phase of NA (characterized by severe pain and inflammation of the brachial plexus)
• (Prior) NA attacks of the lumbosacral plexus or the left upper extremity
• Sever comorbidity
• Any (bio)mechanical constraints of the shoulder girdle
• Any other central nervous system, neurological, or neuromuscular disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific rehabilitation program; Specific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy.	Behavioral: Specific rehabilitation program; 17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic in week 1. During this visit, the patient will be examined by a multidisciplinary team, consisting of a rehabilitation physician, neurologist, physical therapist and occupational therapist, which will form a rehabilitation treatment plan. This treatment plan is implemented through 4 weekly sessions in week 2-5, 2 biweekly sessions in week 6-9 and 2 monthly sessions in week 10-17 . Each treatment session involves one hour of physical- and one hour of occupational therapy.
Other: Usual Care; Usual care for people with neuralgic amyotrophy, may vary per individual	Behavioral: Specific rehabilitation program; 17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic in week 1. During this visit, the patient will be examined by a multidisciplinary team, consisting of a rehabilitation physician, neurologist, physical therapist and occupational therapist, which will form a rehabilitation treatment plan. This treatment plan is implemented through 4 weekly sessions in week 2-5, 2 biweekly sessions in week 6-9 and 2 monthly sessions in week 10-17 . Each treatment session involves one hour of physical- and one hour of occupational therapy.; Other: Usual Care; Participants will receive their usual care for 17 weeks, which may vary for each individual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Shoulder Rating Questionnaire (SRQ) score from baseline	Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ	Baseline (0 weeks) and post-intervention (17 weeks)
Change in brain activity related to central motor control from baseline	Change in the magnitudes of mean functional Magnetic Resonance Imaging signal (Blood-oxygen-level dependent (BOLD) activity) related to motor imagery of the affected arm, quantifying changes in central motor control	Baseline (0 weeks) and post-intervention (17 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in performance on motor imagery tasks assessing motor control	Change in performance on motor imagery tasks. Performance is evaluated by means of reaction times and error rates.	Baseline (0 weeks), post-intervention (17 weeks)
Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline	Change in functional (dis)ability of the shoulder, arm and hand measured with the DASH	Baseline (0 weeks), post-intervention (17 weeks)
Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline	Change in experienced fatigue	Baseline (0 weeks), post-intervention (17 weeks)
Change in McGill Pain Questionnaire (MPQ) score from baseline	Change in nature, intensity, location, course, and effect on daily life of experienced pain	Baseline (0 weeks), post-intervention (17 weeks)
Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline	Change in patient's perceived ability to apply energy conservation strategies to their daily life	Baseline (0 weeks), post-intervention (17 weeks)
Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline	Change in patient's participation	Baseline (0 weeks), post-intervention (17 weeks)
Change in Pain self efficacy questionnaire (PSEQ) score from baseline	Change in confidence people with ongoing pain have in performing activities while in pain.	Baseline (0 weeks), post-intervention (17 weeks)
Change in Patient activation measure (PAM) score from baseline	Change in knowledge, skills and confidence in managing one's own health and/or disease	Baseline (0 weeks), post-intervention (17 weeks)
Change in Short-form 36 (SF-36) score from baseline	Change in experienced health and health related quality of life	Baseline (0 weeks), post-intervention (17 weeks)
Change in serratus anterior muscle strength from baseline	Change in maximal force exerted with the serratus anterior muscle from baseline, measured when reaching with extended arm and flexed arm	Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder endorotation strength from baseline	Change in maximal force exerted while endorotating the shoulder	Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder exorotation strength from baseline	Change in maximal force exerted while exorotating the shoulder	Baseline (0 weeks), post-intervention (17 weeks)
Change in key grip strength from baseline	Change in maximal force exerted while performing a key grip	Baseline (0 weeks), post-intervention (17 weeks)
Change in pinch grip strength from baseline	Change in maximal force exerted while performing a pinch grip	Baseline (0 weeks), post-intervention (17 weeks)
Change in hand grip strength from baseline	Change in maximal force exerted while performing a hand grip	Baseline (0 weeks), post-intervention (17 weeks)
Change in reachable workspace from baseline	Reachable workspace is an objective measure of upper extremity impairment. Reachable workspace is quantified by the relative surface area representing the portion of the unit hemisphere that is covered by the hand movements made during a standardized movement protocol which covers cardinal movements of the shoulder	Baseline (0 weeks), post-intervention (17 weeks)

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Princess Beatrix Muscle Foundation
• Investigators: Principal Investigator: Jan T Groothuis, PhD, MD, Radboud University Medical Center

Publications and helpful links

General Publications

• Ijspeert J, Janssen RM, Murgia A, Pisters MF, Cup EH, Groothuis JT, van Alfen N. Efficacy of a combined physical and occupational therapy intervention in patients with subacute neuralgic amyotrophy: a pilot study. NeuroRehabilitation. 2013;33(4):657-65. doi: 10.3233/NRE-130993.
• Lustenhouwer R, van Alfen N, Cameron IGM, Toni I, Geurts ACH, Helmich RC, van Engelen BGM, Groothuis JT. NA-CONTROL: a study protocol for a randomised controlled trial to compare specific outpatient rehabilitation that targets cerebral mechanisms through relearning motor control and uses self-management strategies to improve functional capability of the upper extremity, to usual care in patients with neuralgic amyotrophy. Trials. 2019 Aug 7;20(1):482. doi: 10.1186/s13063-019-3556-4.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): February 22, 2021

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical therapy; Occupational therapy; Motor control
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Heart Defects, Congenital; Cardiovascular Abnormalities; Chromosome Disorders; Sex Chromosome Disorders; Sex Chromosome Disorders of Sex Development; Brachial Plexus Neuropathies; Neuritis; Muscular Atrophy; Turner Syndrome; Gonadal Dysgenesis; Brachial Plexus Neuritis
• Other Study ID Numbers: 104752

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No