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Neck PainDidRenNCT04407637

Kinematic Cervical Rotation Performance in Neck Pain Patients is Improved After Cervical Treatment

An observational study of Neck Pain, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A longitudinal study is designed to assess the influence of acute non-specific neck pain on kinematic parameters during a fast-head axial rotation task standardized with the DidRen laser test device. First, the investigators will compare kinematic parameters between patients and healthy control. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Neck Pain
How many people
42 participants
Where
1 siteBelgium
Study dates
5 Jan 2019to 19 Dec 2019
Phase
Observational
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with acute non-specific neck pain were consecutively recruited from a private manual physiotherapy center as sample of convenience. Healthy were recruited from student population.

Who may be able to join

  • Patients: Inclusion criteria were acute (<3months) non-specific neck pain with a neck disability index (NDI) > 8% and a Numerical Pain Rating Scale (NPRS) >3.
  • Healthy control participants were included if they reported a NDI < 8% and a NPRS =0. They were excluded if they reported neck pain during the last year, radiating symptoms in the shoulder or arm regions, or headache. Participants with a history of neck trauma or in treatment for spinal disorders or reporting pain during the manual assessment were excluded as well.

Who cannot join

  • Patients were excluded if they reported any of the following: a history of neck surgery, dizziness caused by neck or head movements and cervical radiculopathy diagnosed by a physician.
  • Healthy: They were excluded if they reported neck pain during the last year, radiating symptoms in the shoulder or arm regions, or headache. Participants with a history of neck trauma or in treatment for spinal disorders or reporting pain during the manual assessment were excluded as well.

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Detrembleur

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Kinematic Axial Cervical Rotation Performance in Patients With Acute Non-specific Neck Pain During the DidRen Laser Test is Improved After Passive Manual Cervical Mobilizations Regardless of the Painful Spinal Level

A longitudinal study is designed to assess the influence of acute non-specific neck pain on kinematic parameters during a fast-head axial rotation task standardized with the DidRen laser test device. First, the investigators will compare kinematic parameters between patients and healthy control. Second, the investigators will assess whether neck upper or lower pain location influenced kinematic parameters. Finally, the investigators will examine the short-term effect of passive cervical mobilizations in patients on these kinematic variables.

Read the detailed description

At baseline, all participants will be asked to fill in four questionnaires.

  • The Neck Disability Index (NDI), which is a self-rated instrument assessing disability due to neck pain, which consist of a series of 10 questions on activities relating to daily living all assessed on a 6-point scale.
  • The Numerical Pain Rating Scale (NPRS), to assess the current neck pain.
  • The Tampa scale of kinesiophobia (TSK), which is a 17-item questionnaire used to assess fear of movement or re-injury, in which participants are asked to rate their level of agreement with each item on a 1 (strongly disagree) to 4 (strongly agree) scale. The TSK has been shown to have adequate internal consistency (coefficient alpha 0.77) and to be associated with measures of behavioral avoidance and self-reported disability.A cut-off score above 39 is associated with a risk for prolonged pain-related disability.
  • The French version of the Bournemouth Questionnaire based on the biopsychosocial model to evaluate different dimensions in neck pain participant including the pain, disability, affective and cognitive aspects of neck pain.

The investigators will assess the Fast Neck Rotation with the DidRen Test:

Also, clinical examination will include Cervical Rotation Testing, Manual Spinal Examination.

  • The Didren laser test will be performed by the participant. During the DidRen Laser test, the kinematic rotation will be recorded using a validated Inertial Motion Unit (IMU). After the DidRen test, participant will rate their pain using the NPRS in order to assess if the pain intensity could interfere with the test performance.
  • Measurements of cervical Rotation active range of motion (ROM) will be measured by an IMU. During active cervical ROM measurement participants will be asked to report any familiar pain on a Numerical Pain Rating Scale (NPRS). If no pain during active movement is reported, then the physiotherapist will passively move the head toward end of the ROM and note any stiffness and/or reported familiar pain from the participants. A positive cervical Rotation ROM test will be defined as the reproduction of stiffness and/or familiar cervical spine pain during the active ROM without or with over pressure.
  • The Manual spinal examination will include Passive Physiological Intervertebral Movements (PPIVM's) in lateral flexion and extension and Passive Accessory Intervertebral Movements (PAIVM's), will be performed to detect the presence or absence of cervical joint dysfunction and to detect the region of the dysfunction either on the upper or lower region.The participant will be positioned supine for the PPIVM's and prone for the PAIVM's. For the PAIVM's, the assessor will apply centrally directed posterior-anterior (central P/A) force toward the spinous process or posterior-anterior directed force to the articular pillars (unilateral P/A) from the upper cervical region C0-1, C1-2 and C2-3 to the lower region C6-7 on each side. Any perceived resistance to passive motion will be recorded. The participant will be asked to report any familiar pain provocation on an NPRS. A positive test at a cervical level will be defined as a report of familiar local or referred pain when the assessor rate resistance to passive motion (Manual Spinal examination test have demonstrated moderate to excellent intrarater and interrater reliability in patients with axial neck pain referred for diagnostic facet joint blocks).

On the basis of the findings of the region of pain, subjects will enter either in the upper or lower cervical region group.

Regular baseline on the fast-head rotation task strategies standardized with the "DidRen Laser" device will be done by analyzing data from a control group constituted by asymptomatic subjects. As Manual Spinal Examination (P/A) has showed more sensitivity than specificity, asymptomatic subjects will also be excluded by the second assessor if during cervical Rotation ROM testing procedure and/or cervical manual examination.

Evaluation of Rotation ROM, Spinal Examination and first DidRen Test, will have already been completed.

The participant's treatment will include P/A mobilization . After treatment, Cervical ROM testing and the assessment of the fast Neck Rotation with the DidRen Test will be undergone by the participant:

The Therapist will apply PPIVM's at the symptomatic levels or PAIVM's either central posterior-anterior (central P/A) directed force toward the spinous process ora posterior-anterior directed force directed to the articular pillars (unilateral P/A) on spinal level(s) which were primary recorded as painful sites during the first spinal examination and referred to as "primary painful sites". As a treatment, Maitland Grade 3 and 4 will be used for the joint(s) mobilization(s) and could be performed at others symptomatic levels (these levels will be referred to as "secondary painful sites") depending on the subject's condition (which also contributes to reproduce familiar pain and /or stiffness). During treatment, the Musculoskeletal Physiotherapist will note all cervical levels mobilized, time and grades of movement used. The decision of the end of the treatment will be decided with minimal clinically important improvement (MCI) in pain and in disability. The MCI in pain is defined as a decrease by at least 2 points in pain intensity score at follow-up compared to baseline. The MCI in disability was defined as a decrease by at least 1 point in pain related disability (ROM) score at follow-up compared to baseline.

Assessment of cervical ROM (active + over pressure) by the IMU.The treatment will be performed a second time if no change occurs (MCI disability) after the first manual spinal treatment.

Assessment by the Didren laser test will be performed by the participant. After the DidRen test, participants will complete NPRS, in order to assess if the pain intensity could interfere with the performance of the test.

Musculoskeletal experience. · For blinding purposes, a second assessor will complete the DidRen Laser test.

Conditions
Neck Pain
Keywords
fast neck rotation, sensorimotor control assessment
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04407637
Study groupRoleWhat they receive
neck pain patientsPatients with acute non-specific neck pain were consecutively recruited from a private manual physiotherapy center as sample of convenience. Inclusion criteria were acute (<3months) non-specific neck pain with a neck disability index (NDI) > 8% and a Numerical Pain Rating Scale (NPRS) >3 . Patients were excluded if they reported any of the following: a history of neck surgery, dizziness caused by neck or head movements and cervical radiculopathy diagnosed by a physician.
healthyHealthy control participants were included if they reported a NDI < 8% and a NPRS =0. They were excluded if they reported neck pain during the last year, radiating symptoms in the shoulder or arm regions, or headache. Participants with a history of neck trauma or in treatment for spinal disorders or reporting pain during the manual assessment were excluded as well.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of head rotational speed (in °s-1)

    The head rotational speed (°s-1) was recorded using an inertial motion unit sensor. DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.

    Measured: T0: Before treatment; T1: after 6 weeks

  2. Change of head rotational acceleration (in °s-2)

    The head rotational acceleration (°s-2) was recorded using an inertial motion unit sensor. DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.

    Measured: T0: Before treatment; T1: after 6 weeks

  3. Change of head angular displacement (in °)

    The head angular displacement (°) was recorded using an inertial motion unit sensor. The DYSKIMOT is an Ultra-Low-Cost Inertial Sensor to Assess Head's Rotational Kinematics in Adults during the Didren-Laser Test.

    Measured: T0: Before treatment; T1: after 6 weeks

Secondary outcomes (1)
  1. Change of Numerical Pain Rating Scale (NPRS).

    The Numerical Pain Rating Scale (NPRS) is a commonly used outcome to assess patients with neck pain. It uses an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable)

    Measured: T0: Before treatment; T1: after 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start5 Jan 2019
  3. Primary completion2 Feb 2019
  4. Study completion19 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407637
Sponsor's protocol ID
RH_05_13_20
Acronym
DidRen
Status last verified
May 2020
First submitted
14 May 2020
Last updated
29 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hage R, Detrembleur C, Dierick F, Brismee JM, Roussel N, Pitance L. Sensorimotor performance in acute-subacute non-specific neck pain: a non-randomized prospective clinical trial with intervention. BMC Musculoskelet Disord. 2021 Dec 4;22(1):1017. doi: 10.1186/s12891-021-04876-4.

    PubMed 34863120

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

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 2 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 29 May 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 Belgium. 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?

Change of head rotational speed (in °s-1) (time frame: T0: Before treatment; T1: after 6 weeks). The study lists 3 primary outcomes in all. 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 NCT04407637, 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 29 May 2020.

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