Back to resultsNeurodynamic Interventions for Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Therapy
Physical Therapy plus Neurodynamic
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring neurodynamics, pain
Eligibility Criteria
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
Sites / Locations
- César Fernández-de-las-Peñas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physical Therapy
Physical Therapy plus neurodynamic
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in pressure pain sensitivity
Pressure pain threshold over the median, ulnar and radial nerves, second metacarpal and tibialis anterior
Secondary Outcome Measures
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
Changes in light touch detection threshold
Light touch detection threshold will be assessed with a standardized set of modified twenty von Frey hairs
Changes in manual dexterity
Bilateral manual dexterity was bilaterally assessed using the nine-hole peg test
Full Information
NCT ID
NCT03595631
First Posted
July 2, 2018
Last Updated
October 19, 2018
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT03595631
Brief Title
Neurodynamic Interventions for Multiple Sclerosis
Official Title
Effects of Neurodynamic Interventions to Multimodal Physical Therapy in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
October 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
neurodynamics, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Physical Therapy plus neurodynamic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy plus Neurodynamic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in pressure pain sensitivity
Description
Pressure pain threshold over the median, ulnar and radial nerves, second metacarpal and tibialis anterior
Time Frame
Baseline and one week after the last treatment session
Secondary Outcome Measure Information:
Title
Changes in upper extremity pain intensity before and after the intervention
Description
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
Time Frame
Baseline and one week after the last treatment session
Title
Changes in light touch detection threshold
Description
Light touch detection threshold will be assessed with a standardized set of modified twenty von Frey hairs
Time Frame
Baseline and after treatmentBaseline and one week after the last treatment session
Title
Changes in manual dexterity
Description
Bilateral manual dexterity was bilaterally assessed using the nine-hole peg test
Time Frame
Baseline and one week after the last treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
César Fernández-de-las-Peñas
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35101724
Citation
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.
Results Reference
derived
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Neurodynamic Interventions for Multiple Sclerosis
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