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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03595631
Other study ID # PI-URJC 572
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 26, 2018
Est. completion date October 4, 2018

Study information

Verified date October 2018
Source Universidad Rey Juan Carlos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 4, 2018
Est. primary completion date September 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Spain César Fernández-de-las-Peñas Alcorcon Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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