Neck PainNCT03603054
The Effect of Lower Limbs Neural Mobilization in Subjects With Cervical Pain.
A study testing Active neck mobilization and Active Mobilization of the sciatic nerve in people with Neck Pain, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
No studies have investigated the effects of a Sciatic nerve mobilization in subjects with neck pain. This study aims to determine the immediate effects of a lower limbs neural mobilization on cervical range of motion and on the perception of pain in the most common trigger points located in the cervical musculature. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Active neck mobilization and Active Mobilization of the sciatic nerve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2018to 30 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To spend more than 3 hours at the computer.
- To have or have had neck pain during the last 3 weeks.
Who cannot join
- To have had traumatisms, traffic accidents and surgeries in the last 2 months.
- To have taken any analgesic tablets before the treatment.
- To be in a physiotherapy treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysing the Immediate Effects of Sciatic Nerve Mobilization on the Range of Cervical Mobility and on the Myofascial Trigger Points of the Cervical Muscles. Pilot Study.
No studies have investigated the effects of a Sciatic nerve mobilization in subjects with neck pain. This study aims to determine the immediate effects of a lower limbs neural mobilization on cervical range of motion and on the perception of pain in the most common trigger points located in the cervical musculature.
Read the detailed description
A convenience sample will be used to obtain subjects The subjects will be recruited through posted advertisements on social networks. The inclusion and exclusion criteria will be applied to the volunteers. The sample wil comprise university students and administrative workers with neck pain. The subjects will be screened by a screening questionnaire and all of them, they will be required to sign an inform consent before participating to the study. After signing it, they will be randomly divide into control group subject to a placebo technique and the intervention group subject to an active mobilization of the sciatic nerve.
To assess changes in cervical articular range, will be used, a cervical goniometer (CROM) and for changes in pressure pain threshold of the trigger points will be used a mechanical algometer. Furthermore, to asses changes in pain perception will be used a visual numerical scale. The statistical analysis will be performed using the statistical program SPSS 25.0, comparing the results between both groups.
- Conditions
- Neck Pain
- Being tested
- Active neck mobilization, Active Mobilization of the sciatic nerve
- Keywords
- Neck pain, Neural mobilization, Myofascial trigger point, Sciatic nerve
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active neck mobilizationOther
The subjects, receive an active neck mobilization intervention.
Active Mobilization of the sciatic nerveOther
The subjects, receive an active sciatic nerve mobilization intervention.
| Study group | Role | What they receive |
|---|---|---|
| Active neck mobilization | Active comparator | The subjects, who were randomly allocated to group active neurodynamic mobilization group, will receive the active sciatic nerve mobilization intervention. The subject will be instructed to do a a modification of the slump. The procedure will be performed 1 minute with each leg, two times, the subjects will rest one minute between each mobilization and between series. Receives: Other: Active neck mobilization |
| Active Mobilization of the Sciatic nerve | Experimental | The subjects, who were randomly allocated to group active neurodynamic mobilization group, will receive the active sciatic nerve mobilization intervention. The subject will be instructed to do a a modification of the slump. The procedure will be performed 1 minute with each leg, two times, the subjects will rest one minute between each mobilization and between series. Receives: Other: Active Mobilization of the sciatic nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level at rest
A Visual Analog Scale, will be used for recording level of pain at rest. The VAS evaluates levels of pain intensity using an 10-point scale (range 0-10), with 0 being classified as "no sensation" and 10 "pain as bad as could be".
Measured: Change from baseline in Visual Analog Scale at 2 minutes after intervention
Secondary outcomes (5)
Cervical Range of Motion (CROM)
The Cervical Range of Motion (CROM) device will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.
Measured: Before intervention and 2 minutes after
Mechanical pressure Algometer
The Mechanical pressure Algometer will be used to measure changes in pain threshold of sensitive points located in the cervical musculature.
Measured: Before intervention and 2 minutes after
Vernier caliper
The Vernier caliper will be used to measure the active opening of the mouth.
Measured: Before intervention and 2 minutes after
The Neck Disability Index, Spanish version
The Neck Disability Index questionnaire is a reliable instrument to assess functional disability in neck pain patients. Will be used to assess the subjects' perceived disability level and how their neck pain affect to their daily live.
Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The test can be interpretated as a raw score, with a maximum score of 50, or as a percentage.
0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation.
Measured: Before intervention
Hours of daily use of display screens
The subjects will be asked at the beginning of the study about how many hours they spend using display screens daily.
Measured: Before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Aug 2018
- Primary completion1 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Model description
- The study sample will be randomly divide into 2 groups, a control group subject to a placebo technique and an intervention group subject to an active mobilization of the sciatic nerve.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roser Bel-lan Roldan, Universidad Miguel Hernandez de Elche
- Investigators
- Sergio Hernández-Sánchez, PhD-PT, Study director, Universidad Miguel Hernandez de ElcheCarlos Lozano-Quijada, PhD-PT, Study director, Universidad Miguel Hernandez de ElcheRoser Bel-lan, PT, Principal investigator, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603054
- Sponsor's protocol ID
- DPC.EPP.02.18
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysing the Immediate Effects of Sciatic Nerve Mobilization on the Range of Cervical Mobility and on the Myofascial Trigger Points of the Cervical Muscles. Pilot Study.
- ClinicalTrials.gov ID
- NCT03603054
- Acronym / sponsor ID
- DPC.EPP.02.18
- Conditions
- Neck Pain
- Keywords
- Neck pain, Neural mobilization, Myofascial trigger point, Sciatic nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 27 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.
No studies have investigated the effects of a Sciatic nerve mobilization in subjects with neck pain. This study aims to determine the immediate effects of a lower limbs neural mobilization on cervical range of motion and on the perception of pain in the most common trigger points located in the cervical musculature.
Detailed description
A convenience sample will be used to obtain subjects The subjects will be recruited through posted advertisements on social networks. The inclusion and exclusion criteria will be applied to the volunteers. The sample wil comprise university students and administrative workers with neck pain. The subjects will be screened by a screening questionnaire and all of them, they will be required to sign an inform consent before participating to the study. After signing it, they will be randomly divide into control group subject to a placebo technique and the intervention group subject to an active mobilization of the sciatic nerve.
To assess changes in cervical articular range, will be used, a cervical goniometer (CROM) and for changes in pressure pain threshold of the trigger points will be used a mechanical algometer. Furthermore, to asses changes in pain perception will be used a visual numerical scale. The statistical analysis will be performed using the statistical program SPSS 25.0, comparing the results between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study sample will be randomly divide into 2 groups, a control group subject to a placebo technique and an intervention group subject to an active mobilization of the sciatic nerve.
| Arm | Type | Receives |
|---|---|---|
| Active neck mobilization | Active comparator | Other: Active neck mobilizationThe subjects, who were randomly allocated to group active neurodynamic mobilization group, will receive the active sciatic nerve mobilization intervention. The subject will be instructed to do a a modification of the slump. The procedure will be performed 1 minute with each leg, two times, the subjects will rest one minute between each mobilization and between series. |
| Active Mobilization of the Sciatic nerve | Experimental | Other: Active Mobilization of the sciatic nerveThe subjects, who were randomly allocated to group active neurodynamic mobilization group, will receive the active sciatic nerve mobilization intervention. The subject will be instructed to do a a modification of the slump. The procedure will be performed 1 minute with each leg, two times, the subjects will rest one minute between each mobilization and between series. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- To spend more than 3 hours at the computer.
- To have or have had neck pain during the last 3 weeks.
Key exclusion criteria (3 listed)
- To have had traumatisms, traffic accidents and surgeries in the last 2 months.
- To have taken any analgesic tablets before the treatment.
- To be in a physiotherapy treatment.
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 |
|---|---|---|
| Active neck mobilizationThe subjects, receive an active neck mobilization intervention. | Other | Active neck mobilization |
| Active Mobilization of the sciatic nerveThe subjects, receive an active sciatic nerve mobilization intervention. | Other | Active Mobilization of the Sciatic nerve |
Primary outcome
Pain level at rest
Time frame: Change from baseline in Visual Analog Scale at 2 minutes after intervention
A Visual Analog Scale, will be used for recording level of pain at rest. The VAS evaluates levels of pain intensity using an 10-point scale (range 0-10), with 0 being classified as "no sensation" and 10 "pain as bad as could be".
5 secondary outcomes
Cervical Range of Motion (CROM)
Time frame: Before intervention and 2 minutes after
Mechanical pressure Algometer
Time frame: Before intervention and 2 minutes after
Vernier caliper
Time frame: Before intervention and 2 minutes after
The Neck Disability Index, Spanish version
Time frame: Before intervention
Hours of daily use of display screens
Time frame: Before intervention
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 3 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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.
Sergio Hernández-Sánchez, PhD-PT study director
Universidad Miguel Hernandez de Elche
Carlos Lozano-Quijada, PhD-PT study director
Universidad Miguel Hernandez de Elche
Roser Bel-lan, PT principal investigator
Universidad Miguel Hernandez de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active neck mobilization and Active Mobilization of the sciatic nerve in people with Neck Pain, run by Universidad Miguel Hernandez de Elche 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 2 inclusion and 3 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 3 Dec 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?
Pain level at rest (time frame: Change from baseline in Visual Analog Scale at 2 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2018.