Chronic PainObACNPainNCT02553759
Observed Actions in Chronic Neck Pain
A study testing Actions observed in people with Chronic Pain, run by AG Clinic.
Trial summary
The aim of the present protocol is to prove if the observed actions (AOb) will improve the cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This study is a parallel-group double blind randomized clinical. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Actions observed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non specific chronic neck pain
- Diagnosed by medical specialist
Who cannot join
- cervical osteoarthritis or polyarthrosis
- rheumatic disease
- history of cervical hernia
- whiplash syndrome
- surgery on the neck, face or shoulders,
- systemic disease, medical history of cancer
- significant trauma that the patient relates to their pain and/or refusal to participate
About this study
Official title: Influence of the Actions Observed on Cervical Motion in Patients With Chronic Neck Pain. Randomized Controlled Trial
The aim of the present protocol is to prove if the observed actions (AOb) will improve the cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second measurement (motor imagery).
- Conditions
- Chronic Pain
- Being tested
- Actions observed
- Keywords
- observed action, range of motion, mirror neuron
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actions observedOther
Patients observed movements without realize them. After this actions, movements will be imagined by patients
| Study group | Role | What they receive |
|---|---|---|
| Effective movement | Experimental | This group will see a 1-minute video showing an individual performing a cervical rotation movement to each side, first 10 times towards the right and then 10 times towards the left. The movement will be performed effectively over the entire course of the cervical path, approximately 80º Receives: Other: Actions observed |
| Ineffective movement | Active comparator | This group will see a 1-minute video showing an individual performing a cervical rotation movement ineffectively, without achieving the maximum cervical travel, performing approximately 40º. First, 10 movements towards the right will be performed and then 10 towards the left Receives: Other: Actions observed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion degrees
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AG Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Responsible party
- Principal investigator, Alfonso Gil Martínez, AG Clinic
- Investigators
- Alfonso Gil-Martínez, Master, Study director, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553759
- Sponsor's protocol ID
- ObActions
- Acronym
- ObACNPain
- Status last verified
- Sep 2015
- First submitted
- 16 Sep 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Actions Observed on Cervical Motion in Patients With Chronic Neck Pain. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02553759
- Acronym / sponsor ID
- ObACNPain / ObActions
- Conditions
- Chronic Pain
- Keywords
- observed action, range of motion, mirror neuron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AG ClinicUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
The aim of the present protocol is to prove if the observed actions (AOb) will improve the cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second measurement (motor imagery).
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 |
|---|---|---|
| Effective movement | Experimental | Other: Actions observedThis group will see a 1-minute video showing an individual performing a cervical rotation movement to each side, first 10 times towards the right and then 10 times towards the left. The movement will be performed effectively over the entire course of the cervical path, approximately 80º |
| Ineffective movement | Active comparator | Other: Actions observedThis group will see a 1-minute video showing an individual performing a cervical rotation movement ineffectively, without achieving the maximum cervical travel, performing approximately 40º. First, 10 movements towards the right will be performed and then 10 towards the left |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non specific chronic neck pain
- Diagnosed by medical specialist
Key exclusion criteria (7 listed)
- cervical osteoarthritis or polyarthrosis
- rheumatic disease
- history of cervical hernia
- whiplash syndrome
- surgery on the neck, face or shoulders,
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 |
|---|---|---|
| Actions observedPatients observed movements without realize them. After this actions, movements will be imagined by patients | Other | Effective movement, Ineffective movement |
Primary outcome
Range of motion degrees
Time frame: 10 minutes
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 18 Sep 2015.
Related trials for Chronic Pain
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
Rewiring the Chronic Pain Experience: Single-Session Model of Pain Reprocessing Therapy (PRT) at The Ottawa Hospital
Chronic Pain
Active, not recruiting
Effects of Subtalar Mobilization With and Without Foot Core Strengthening in Chronic Plantar Heel Pain
Chronic Plantar Heel 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.
Alfonso Gil-Martínez, Master study director
Hospital Universitario La Paz
Questions about this trial
What is this clinical trial studying?
A study testing Actions observed in people with Chronic Pain, run by AG Clinic.
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 7 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 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Range of motion degrees (time frame: 10 minutes). 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 18 Sep 2015.