Cervical RadiculopathyNCT04598113
Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients
A study testing Cervical Traction Device in people with Cervical Radiculopathy and Vertigo, run by University of Monastir at 1 site in Tunisia.
Trial summary
A cross-over randomized trial aiming to assess the immediate effect of cervical traction on balance disorders among patients with common cervical neuropathy. Authors hypothesized that as cervical traction alleviate radicular pain it may also improve patient balance disorders. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cervical Radiculopathy, Vertigo
- What is being tested?
- Cervical Traction Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTunisia
- Study dates
- 7 Nov 2020to 20 Mar 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral cervical radiculopathy of greater than three months
Who cannot join
- History of surgery or bone-ligament damage to the cervical spine
- Neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance
- Inner ear and vestibular pathology
- Worsening of pain or intolerance in the manual cervical traction test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients: A Randomized Cross-over Trial)
A cross-over randomized trial aiming to assess the immediate effect of cervical traction on balance disorders among patients with common cervical neuropathy. Authors hypothesized that as cervical traction alleviate radicular pain it may also improve patient balance disorders. Effective traction is compared to sham traction.
Main outcome measures are balance parameters (force platform).
Read the detailed description
A cross-over randomized trial was designed to assess the immediate effect of cervical intermittent traction on balance disorders among patients diagnosed with common cervical neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 Y of experience treating musculoskeletal disorders especially cervical neuropathy. Enrolled patients are randomly assigned to one of two arms (1 or 2). Patients in arm 1 (Effective Traction/Sham Traction) are treated firstly with effective traction than one week later with sham traction. Patients in arm 2 (Sham Traction/Effective Traction) are treated firstly with sham traction than one week later with effective traction. At baseline the epidemiological parameters, the pain intensity (VAS), the grip strength, the functional status (NDI), the psychological distress (HAD), the Brief Best Test and the balance parameters (force platform) are assessed. The pain intensity, the grip strength and the balance parameters are assessed before and immediately after cervical traction for comparison.
- Conditions
- Cervical Radiculopathy, Vertigo
- Being tested
- Cervical Traction Device
- Keywords
- Cervical Radiculopathy, Vertigo, Traction, Balance Postural
- Medical subject headings
- Radiculopathy, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Traction DeviceDevice
While The patient is lie on the back his or her head is housed within the specific head portion of the device. The investigator inflate progressively the device using a valve and ensuring the patient's relaxation. The process of inflation is continued until the level of 12 Kg of pressure is reached. This maximum level of traction is maintained for 10 minutes then the process of deflation is started until the pressure decreased to 0 Kg. This maneuver is reproduced once again after 5 minutes of rest.
The balance assessment using the force plate-from is done just before the intervention and 5 minutes after its end.
| Study group | Role | What they receive |
|---|---|---|
| Effective Traction/Sham Traction | Active comparator | Group of patients treated firstly with Effective Traction then with Sham Traction Receives: Device: Cervical Traction Device |
| Sham Traction/Effective Traction | Sham comparator | Group of patients treated firstly with Sham Traction then with Effective Traction Receives: Device: Cervical Traction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in static posturographic parameters: The center of pressure (CoP) movement: sway area
The CoP sway area (cm2) correspond to the the area which encloses the data points of the trajectory in relation with the body movement. The CoP sway area is assessed in two conditions (with open then closed eyes)
Measured: The CoP sway area assessment is done just before the intervention and 5 minutes after.
Change in static posturographic parameters: The CoP displacement amplitude
The CoP displacement amplitude (cm) in the anterior-posterior and medial-lateral trajectory correspond to the amount of body movement during a certain time interval in both trajectories. The CoP displacement amplitude is assessed in two conditions (with open then closed eyes)
Measured: The CoP displacement amplitude assessment is done just before the intervention and 5 minutes after.
Change in static posturographic parameters: The Cop velocity
The Cop velocity (cm/s) correspond to the velocity of movement of the body. The CoP velocity is assessed in two conditions (with open then closed eyes)
Measured: The Cop velocity assessment is done just before the intervention and 5 minutes after.
Change in static posturographic parameters: The Romberg quotient
The Romberg quotient correpond to the Ratio between Closed and Open Eyes Values of the previous parameters.
Measured: The Romberg quotient assessment is done just before the intervention and 5 minutes after.
Change in static posturographic parameters: CoP position
The CoP position correspond to the location side in the frontal plan (left or right) and in the sagittal plan (anterior or posterior). The CoP position is assessed in two conditions (with open then closed eyes)
Measured: The CoP position assessment is done just before the intervention and 5 minutes after.
Secondary outcomes (2)
Change in pain intensity
The pain is assessed using a visual analog scale(VAS) /100 mm (minimum 0 mm and maximum 100 mm). The higher the score the worse the patient's pain.
Measured: The pain assessement is done just before the intervention and 5 minutes after
Change in grip strength (Kg)
The grip strength is measured using Jamar Hydraulic Hand Dynamometer
Measured: The measure is done just before the intervention and 5 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start7 Nov 2020
- Primary completion13 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- Crossover
- Model description
- Two interventions: Effective Traction (ET) and Sham Traction (ST) Two arms: Arm 1: Effective Traction/Sham Traction (ET than ST) and Arm 2: Sham Traction/Effective Traction (ST than ET) Wash out period = 1 week
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anis Jellad, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598113
- Sponsor's protocol ID
- CTB
- Status last verified
- Jul 2021
- First submitted
- 30 Sep 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients: A Randomized Cross-over Trial)
- ClinicalTrials.gov ID
- NCT04598113
- Acronym / sponsor ID
- CTB
- Conditions
- Cervical Radiculopathy, Vertigo
- Keywords
- Cervical Radiculopathy, Vertigo, Traction, Balance Postural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 22 Oct 2020 (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 cross-over randomized trial aiming to assess the immediate effect of cervical traction on balance disorders among patients with common cervical neuropathy. Authors hypothesized that as cervical traction alleviate radicular pain it may also improve patient balance disorders. Effective traction is compared to sham traction.
Main outcome measures are balance parameters (force platform).
Detailed description
A cross-over randomized trial was designed to assess the immediate effect of cervical intermittent traction on balance disorders among patients diagnosed with common cervical neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 Y of experience treating musculoskeletal disorders especially cervical neuropathy. Enrolled patients are randomly assigned to one of two arms (1 or 2). Patients in arm 1 (Effective Traction/Sham Traction) are treated firstly with effective traction than one week later with sham traction. Patients in arm 2 (Sham Traction/Effective Traction) are treated firstly with sham traction than one week later with effective traction. At baseline the epidemiological parameters, the pain intensity (VAS), the grip strength, the functional status (NDI), the psychological distress (HAD), the Brief Best Test and the balance parameters (force platform) are assessed. The pain intensity, the grip strength and the balance parameters are assessed before and immediately after cervical traction for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two interventions: Effective Traction (ET) and Sham Traction (ST) Two arms: Arm 1: Effective Traction/Sham Traction (ET than ST) and Arm 2: Sham Traction/Effective Traction (ST than ET) Wash out period = 1 week
| Arm | Type | Receives |
|---|---|---|
| Effective Traction/Sham Traction | Active comparator | Device: Cervical Traction DeviceGroup of patients treated firstly with Effective Traction then with Sham Traction |
| Sham Traction/Effective Traction | Sham comparator | Device: Cervical Traction DeviceGroup of patients treated firstly with Sham Traction then with Effective Traction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unilateral cervical radiculopathy of greater than three months
Key exclusion criteria (4 listed)
- History of surgery or bone-ligament damage to the cervical spine
- Neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance
- Inner ear and vestibular pathology
- Worsening of pain or intolerance in the manual cervical traction test
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 |
|---|---|---|
| Cervical Traction DeviceWhile The patient is lie on the back his or her head is housed within the specific head portion of the device. The investigator inflate progressively the device using a valve and ensuring the patient's relaxation. The process of inflation is continued until the level of 12 Kg of pressure is reached. This maximum level of traction is maintained for 10 minutes then the process of deflation is started until the pressure decreased to 0 Kg. This maneuver is reproduced once again after 5 minutes of rest. The balance assessment using the force plate-from is done just before the intervention and 5 minutes after its end. | Device | Effective Traction/Sham Traction, Sham Traction/Effective Traction |
Primary outcome
Change in static posturographic parameters: The center of pressure (CoP) movement: sway area
Time frame: The CoP sway area assessment is done just before the intervention and 5 minutes after.
The CoP sway area (cm2) correspond to the the area which encloses the data points of the trajectory in relation with the body movement. The CoP sway area is assessed in two conditions (with open then closed eyes)
Change in static posturographic parameters: The CoP displacement amplitude
Time frame: The CoP displacement amplitude assessment is done just before the intervention and 5 minutes after.
The CoP displacement amplitude (cm) in the anterior-posterior and medial-lateral trajectory correspond to the amount of body movement during a certain time interval in both trajectories. The CoP displacement amplitude is assessed in two conditions (with open then closed eyes)
Change in static posturographic parameters: The Cop velocity
Time frame: The Cop velocity assessment is done just before the intervention and 5 minutes after.
The Cop velocity (cm/s) correspond to the velocity of movement of the body. The CoP velocity is assessed in two conditions (with open then closed eyes)
Change in static posturographic parameters: The Romberg quotient
Time frame: The Romberg quotient assessment is done just before the intervention and 5 minutes after.
The Romberg quotient correpond to the Ratio between Closed and Open Eyes Values of the previous parameters.
Change in static posturographic parameters: CoP position
Time frame: The CoP position assessment is done just before the intervention and 5 minutes after.
The CoP position correspond to the location side in the frontal plan (left or right) and in the sagittal plan (anterior or posterior). The CoP position is assessed in two conditions (with open then closed eyes)
2 secondary outcomes
Change in pain intensity
Time frame: The pain assessement is done just before the intervention and 5 minutes after
Change in grip strength (Kg)
Time frame: The measure is done just before the intervention and 5 minutes after
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 20 Jul 2021.
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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.
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 Cervical Traction Device in people with Cervical Radiculopathy and Vertigo, run by University of Monastir at 1 site in Tunisia.
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 4 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 20 Jul 2021. 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 Tunisia. 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. Some participants in this study may receive a placebo. 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 in static posturographic parameters: The center of pressure (CoP) movement: sway area (time frame: The CoP sway area assessment is done just before the intervention and 5 minutes after.). The study lists 5 primary outcomes in all. 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 20 Jul 2021.