Neurodynamic Interventions for Multiple Sclerosis

Effects of Neurodynamic Interventions to Multimodal Physical Therapy in Patients With Multiple Sclerosis

A randomized, parallel-group, clinical trial will be conducted to compare the immediate effects of the inclusion of a neurodynamic intervention into a multimodal physiotherapy program on pressure pain sensitivity, pain and manual dexterity in patients with multiple sclerosis

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Physical Therapy; Other: Physical Therapy plus Neurodynamic

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • César Fernández-de-las-Peñas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• a diagnosis of multiple sclerosis according to the modified McDonald criteria;
• symptoms of paresthesia and lack of sensitivity in the upper extremity;
• Expanded Disability Status Scale (EDSS) between 0 and 6.5 points;
• absence of cognitive deficit.

Exclusion Criteria:

• any exacerbation of multiple sclerosis during the previous 3 months;
• previous hand surgery or steroid injections treatment in the upper extremity;
• multiple diagnoses on the upper extremity (e.g., cervical radiculopathy);
• cervical, shoulder, or upper extremity trauma;
• other comorbid musculoskeletal medical conditions;
• mini-mental state examination <25

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Physical Therapy; Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week.	Other: Physical Therapy; Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week.
EXPERIMENTAL: Physical Therapy plus neurodynamic; Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week. In addition, they will also receive bilateral nerve slider neurodynamic interventions targeting the median, ulnar and radial nerves.	Other: Physical Therapy plus Neurodynamic; Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week. In addition, they will also receive bilateral nerve slider neurodynamic interventions targeting the median, ulnar and radial nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pressure pain sensitivity	Pressure pain threshold over the median, ulnar and radial nerves, second metacarpal and tibialis anterior	Baseline and one week after the last treatment session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in upper extremity pain intensity before and after the intervention	A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record the mean and the worst intensity of pain in te upper extremity	Baseline and one week after the last treatment session
Changes in light touch detection threshold	Light touch detection threshold will be assessed with a standardized set of modified twenty von Frey hairs	Baseline and after treatmentBaseline and one week after the last treatment session
Changes in manual dexterity	Bilateral manual dexterity was bilaterally assessed using the nine-hole peg test	Baseline and one week after the last treatment session

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Publications and helpful links

General Publications

• de Dios Perez-Bruzon J, Fernandez-de-Las-Penas C, Cleland JA, Plaza-Manzano G, Ortega-Santiago R. Effects of neurodynamic interventions on pain sensitivity and function in patients with multiple sclerosis: a randomized clinical trial. Physiotherapy. 2022 Jun;115:36-45. doi: 10.1016/j.physio.2021.04.004. Epub 2021 Apr 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2018
• Primary Completion (ACTUAL): September 15, 2018
• Study Completion (ACTUAL): October 4, 2018

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (ACTUAL): July 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pain; neurodynamics
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: PI-URJC 572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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