Multiple SclerosisNCT03595631
Neurodynamic Interventions for Multiple Sclerosis
A study testing Physical Therapy and Physical Therapy plus Neurodynamic in people with Multiple Sclerosis, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physical Therapy and Physical Therapy plus Neurodynamic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jul 2018to 4 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Multiple Sclerosis
- Being tested
- Physical Therapy, Physical Therapy plus Neurodynamic
- Keywords
- neurodynamics, pain
- Medical subject headings
- Multiple Sclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical Therapy plus Neurodynamic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pressure pain sensitivity
Pressure pain threshold over the median, ulnar and radial nerves, second metacarpal and tibialis anterior
Measured: Baseline and one week after the last treatment session
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Baseline and one week after the last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start26 Jul 2018
- Primary completion15 Sep 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595631
- Sponsor's protocol ID
- PI-URJC 572
- Status last verified
- Oct 2018
- First submitted
- 2 Jul 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35101724
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurodynamic Interventions to Multimodal Physical Therapy in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03595631
- Acronym / sponsor ID
- PI-URJC 572
- Conditions
- Multiple Sclerosis
- Keywords
- neurodynamics, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Active comparator | Other: Physical TherapyPatients 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 | Experimental | Other: Physical Therapy plus NeurodynamicPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyPatients 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 NeurodynamicPatients 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 |
Primary outcome
Changes in pressure pain sensitivity
Time frame: Baseline and one week after the last treatment session
Pressure pain threshold over the median, ulnar and radial nerves, second metacarpal and tibialis anterior
3 secondary outcomes
Changes in upper extremity pain intensity before and after the intervention
Time frame: Baseline and one week after the last treatment session
Changes in light touch detection threshold
Time frame: Baseline and after treatmentBaseline and one week after the last treatment session
Changes in manual dexterity
Time frame: Baseline and one week after the last treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Derived from this study: PubMed 35101724de 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.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Physical Therapy plus Neurodynamic in people with Multiple Sclerosis, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pressure pain sensitivity (time frame: Baseline and one week after the last treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.