NCT03595631

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

July 26, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

July 2, 2018

Last Update Submit

October 19, 2018

Conditions

Multiple Sclerosis

Keywords

neurodynamicspain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in upper extremity pain intensity before and after the intervention

    Baseline and one week after the last treatment session

  • Changes in light touch detection threshold

    Baseline and after treatmentBaseline and one week after the last treatment session

  • Changes in manual dexterity

    Baseline and one week after the last treatment session

Study Arms (2)

Physical Therapy

ACTIVE COMPARATOR

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

Physical Therapy plus neurodynamic

EXPERIMENTAL

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

Interventions

Physical TherapyOTHER

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.

Physical Therapy
Physical Therapy plus NeurodynamicOTHER

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.

Physical Therapy plus neurodynamic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

César Fernández-de-las-Peñas

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35101724DERIVED

MeSH Terms

Conditions

Multiple SclerosisPain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 23, 2018

Study Start

July 26, 2018

Primary Completion

September 15, 2018

Study Completion

October 4, 2018

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)