Neck PainPropNeckPainNCT03218644
Effectiveness of Proprioceptive Exercise in Neck Pain
A study testing Mobility exercises and Proprioception exercises in people with Neck Pain, run by University of Valencia at 1 site in Spain.
Trial summary
Introduction: Neck pain is among the most common and costly for industrialized societies. It is difficult to know the exact structure causing the pain so most are considered as non-specific neck pain. There is a correlation between the alteration of craneocervical proprioception and neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mobility exercises and Proprioception exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jul 2017to 15 Aug 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neck pain (NAD I-II) of recent onset (0-3 months)
Who cannot join
- Cognitive difficulties
- Lack of commitment to attend sessions
- Subjects with pacemakers or defibrillators
- Being receiving another physiotherapeutic treatment
- Other pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Propioceptive Exercise Program in Subjects With Inespecific Neck Pain
Introduction: Neck pain is among the most common and costly for industrialized societies. It is difficult to know the exact structure causing the pain so most are considered as non-specific neck pain. There is a correlation between the alteration of craneocervical proprioception and neck pain. The evidence for treatment with proprioceptive exercises is very limited.
Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to compare its effects with a cervical mobility program.
Materials and Methods: Subjects between 18-65 years old with non-traumatic neck pain are included. They will be randomized into two groups of exercises: proprioception or mobility, which will be developed over a period of two weeks, every day, with a total of 10 sessions per patient.
- Conditions
- Neck Pain
- Being tested
- Mobility exercises, Proprioception exercises
- Keywords
- Proprioception
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility exercisesOther
Usual treatment and exercises of cervical mobility before a mirror.
Proprioception exercisesOther
proprioceptive exercises for craniocervical sensorimotor control.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Follow the usual treatment and perform the exercises of cervical mobility before a mirror. Receives: Other: Mobility exercises |
| Experimental group | Experimental | The same procedure is followed by substituting proprioceptive exercises for craniocervical sensorimotor control with a laser instrument located on the patient's head and a target. Receives: Other: Proprioception exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of Pain
Visual Analogue Scale (VAS) was used to register the pain. The VAS is a 10-point rating scale.
Measured: four weeks
Secondary outcomes (5)
Head Repositioning Test
The cervical position is reevaluated with a laser pointer.
Measured: four weeks
Cervical movement range (CROM)
Evaluated with cervical goniometer.
Measured: four weeks
Pain points
Algometer
Measured: four weeks
Neck Disability
Neck Disability Index
Measured: four weeks
Health status
Evaluated with questionnaire of Quality of life
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start14 Jul 2017
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
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.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma Victoria Espí-López, Principal investigator, fisiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218644
- Sponsor's protocol ID
- ID0017
- Acronym
- PropNeckPain
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2017
- Last updated
- 23 Jul 2020
- 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Propioceptive Exercise Program in Subjects With Inespecific Neck Pain
- ClinicalTrials.gov ID
- NCT03218644
- Acronym / sponsor ID
- PropNeckPain / ID0017
- Conditions
- Neck Pain
- Keywords
- Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 14 Jul 2017 (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.
Introduction: Neck pain is among the most common and costly for industrialized societies. It is difficult to know the exact structure causing the pain so most are considered as non-specific neck pain. There is a correlation between the alteration of craneocervical proprioception and neck pain. The evidence for treatment with proprioceptive exercises is very limited.
Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to compare its effects with a cervical mobility program.
Materials and Methods: Subjects between 18-65 years old with non-traumatic neck pain are included. They will be randomized into two groups of exercises: proprioception or mobility, which will be developed over a period of two weeks, every day, with a total of 10 sessions per patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Mobility exercisesFollow the usual treatment and perform the exercises of cervical mobility before a mirror. |
| Experimental group | Experimental | Other: Proprioception exercisesThe same procedure is followed by substituting proprioceptive exercises for craniocervical sensorimotor control with a laser instrument located on the patient's head and a target. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Neck pain (NAD I-II) of recent onset (0-3 months)
Key exclusion criteria (5 listed)
- Cognitive difficulties
- Lack of commitment to attend sessions
- Subjects with pacemakers or defibrillators
- Being receiving another physiotherapeutic treatment
- Other pathologies
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 |
|---|---|---|
| Mobility exercisesUsual treatment and exercises of cervical mobility before a mirror. | Other | Control group |
| Proprioception exercisesproprioceptive exercises for craniocervical sensorimotor control. | Other | Experimental group |
Primary outcome
Intensity of Pain
Time frame: four weeks
Visual Analogue Scale (VAS) was used to register the pain. The VAS is a 10-point rating scale.
5 secondary outcomes
Head Repositioning Test
Time frame: four weeks
Cervical movement range (CROM)
Time frame: four weeks
Pain points
Time frame: four weeks
Neck Disability
Time frame: four weeks
Health status
Time frame: four weeks
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 23 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Gemma Victoria Espí-López principal investigator
fisiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility exercises and Proprioception exercises in people with Neck Pain, run by University of Valencia 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 1 inclusion and 5 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 23 Jul 2020. 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?
Intensity of Pain (time frame: four weeks). 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 23 Jul 2020.