Cervical RadiculopathyNCT06727747
Effect of Cervical Traction on Balance in Cervical Radiculopathy
A study testing Cervical traction and Rehabilitation in people with Cervical Radiculopathy and Balance Disorders, run by University of Monastir at 1 site in Tunisia.
Trial summary
A randomized clinical trial aiming to assess the effect of cervical traction, using different loads, on balance parameters among patients with common cervical radiculopathy. Authors hypothesized that as cervical traction alleviate radicular pain and improve function it may also improve patient balance parameters. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Radiculopathy, Balance Disorders
- What is being tested?
- Cervical traction and Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Feb 2023to 30 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CR evolving for at least 3 months Well tolerated manual cervical traction test.
Who cannot join
- Rehabilitation or chiropractic treatment for head or neck pain within the previous 3 months.
- neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance.
- Surgery or traumatic damage to the cervical spine.
- Ear, Nose and Throat pathology and ophthalmological disorders causing a balance disorder.
- Diabetes at the stage of neurovegetative complications
- Cardiac arrhythmia
- Neurological impairments (balance disorders, motor and/or sensory deficits).
- Severe osteoporosis or long-term treatment with corticosteroids .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cervical Traction on Balance Parameters in Patients with Cervical Radiculopathy: a Randomized Controlled Trial
A randomized clinical trial aiming to assess the effect of cervical traction, using different loads, on balance parameters among patients with common cervical radiculopathy.
Authors hypothesized that as cervical traction alleviate radicular pain and improve function it may also improve patient balance parameters. Three different loads of traction are compared Main outcome measures are balance parameters (clinical and stabilometric). Patients are followed for during six months.
Read the detailed description
A randomized clinical trial was designed to assess the effect of cervical intermittent traction on balance parameters 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 three groups (A, B and C). Patients are treated with 2 Kg load intermittent cervical traction (A), 8 kg (B) and 12 kg (C). Patients in the three groups are treated additionnally with 12 rehabilitation sessions. Patients are assessed at baseline, at the end of the treatment (1 month), and at 3 and 6 months. Outcomes are mainly clinical balance assessment and stabilometry, and secondary, epidemiological parameters, pain intensity (VAS), cervical spine ROM and proprioception, grip strength, cervical spinal muscle strength, functional status (NDI), the psychological distress (HAD), and Quality of life All parameters are assessed at the Three follow-up points.
- Conditions
- Cervical Radiculopathy, Balance Disorders
- Being tested
- Cervical traction, Rehabilitation
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical tractionOther
Also called Mechanical intermittent cervical traction
Cervical traction procedure was performed using Saunders device. During the procedure, the patient lies in installed in a supine position with 20 degrees of cervical flexion and the physiotherapist gradually increases (5 minutes) the load to the defined kilograms which is maintained for 10 minutes then progressively decreases (5 minutes) the load to zero kilograms. The procedure is performed twice with a rest interval of 5 minutes.
RehabilitationOther
The rehabilitation program compiled cervical spine mobilization, stretching of neck muscles and isometric strengthening exercises. Passive stretching of neck muscles groups was carried-out in a seated position with 3 repetition of 30 seconds each. Isometric strengthening exercises of neck extensors were performed in a seated position, against the resistance of the physiotherapist hand for 3 repetitions of 10 seconds each
| Study group | Role | What they receive |
|---|---|---|
| Group A | Sham comparator | Patients in group A recieved cervical traction with 2 kg load combined with standard rehabilitation program. This group is condidered as sham because the 2 kg load does not have any effect on anatomical structures of the cervical spine. Receives: Other: Cervical traction; Other: Rehabilitation |
| Group B | Active comparator | Patients in group B recieved cervical traction with 8 kg load combined with standard rehabilitation program. The traction load in this group has an effect on muscular structures of the cervical spine without any actual effect on the remaining anatomical structures (intervertabral disks, joints and ligaments). Receives: Other: Cervical traction; Other: Rehabilitation |
| Group C | Experimental | Patients in group C recieved cervical traction with 12 kg load combined with standard rehabilitation program. The traction load in this group has an actual effect on muscles, intervertabral disks, joints, and ligaments of the cervical spine. Receives: Other: Cervical traction; Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilometric balance assessment 1
Center of pressure of the foot sway area (Cop/SA) (mm ²)
Measured: Up to 6 months
Stabilometric balance assessment 2
The lateral displacement length of the center of pressure of the foot (LD) (mm)
Measured: Up to 6 months
Stabilometric balance assessment 3
The anteroposterior displacement length of the center of pressure of the foot (AD) (mm)
Measured: Up to 6 months.
Stabilometric balance assessment 4
The lateral displacement velocity (LV) of the center of pressure of the foot (mm/s)
Measured: Up to 6 months
Stabilometric balance assessment 5
The anteroposterior velocity (AV) of the dispalcement of the center of pressure of the foot(mm/s)
Measured: Up to 6 months
Clinical balance assessment
For the clinical balance assessment, the Brief-BESTest was used. Six categories included in the test (8 scored):
- Biomechanical constraints: Hip strength
- Stability limits/verticality: Reach forward
- Anticipatory postural responses: Stand on one limb: left and right each scored
- Postural responses: Compensatory Stepping right and left each scored
- Sensory orientation: Stance on foam with eyes closed
- Stability in gait: Get up and Go test Each item is scored: 0 - 3 points (0 representing severe impairment and 3 representing no balance impairment).
Total score = 24 points (2 items include both a R/L component)
Measured: Up to 6 months.
Secondary outcomes (18)
Sociodemographic characteristics 1
- Age (years)
Measured: Baseline.
Sociodemographic characteristics 2
Sex (Male or Female)
Measured: Baseline.
Sociodemographic characteristics 3
Medical History (Hypertension, diabetes, others)
Measured: Baseline.
Sociodemographic characteristics 4
Occupation (Employed, unemployed, retired)
Measured: Baseline.
Sociodemographic characteristics 5
Type of Occupation: Shift work (office work, secretary) or manual labor (heavy manual work, carrying loads)
Measured: Baseline.
Sociodemographic characteristics 6
Socioeconomic Level: Poor if the salary is below the guaranteed minimum wage (SMIG : around 400 Tunisian Dinars per month) , Average if the salary is between SMIG and three times SMIG, Good if it is more than three times SMIG.
Measured: Baseline.
Duration of CR
The duration of CR is the length of radicular pain evolution in months.
Measured: Baseline.
Side of CR
The side of CR: Right, left, or bilateral
Measured: Baseline.
Intensity of CR
The intensity of radicular pain was assessed using a Visual Analog Scale (VAS) scored out of 100.
Measured: Baseline.
• Body Mass Index
- Body Mass Index (BMI) (kg/m²)
Measured: Baseline.
Cervical range of motion (ROM)
Cervical ROM was measured using the Cervical Range-of-Motion Instrument (CROM; Performance Attainment Associates, St Paul, MN). With its three inclinometers, the CROM device is a useful clinical instrument for measuring the cervical spine's active mobility in flexion, extension, rotation, and lateral flexion.
Measured: Up to 6 months.
Cervical proprioception
Cervical proprioception was assessed using the CROM device. Patient wearing a CROM device is instructed to maintain a neutral head position while sitting (reference position). Patient is asked to close his eyes and move his head passively before returning it to the reference position by the examiner. The angle inaccuracy is measured in degrees by the examiner. The flexion and extension tests are run .
Measured: Up to 6 months.
Cervical muscles strength
Cervical muscles strength was measured using a handheld isometric dynamometer (MicroFET2; Hoggan Health Industries). Measurements were reported in Newton. To assess the strength of the flexor muscles, the dynamometer is placed on the forehead, while for the extensor muscles, it is placed at the back of the head
Measured: Up to 6 months.
Handgrip strength (HGS)
HGS was measured using the Jamar hydraulic handheld dynamometer (Lafayette Instrument Company, USA) and was reported in kilograms.
Measured: Up to 6 months.
Neck disability assessment
The Neck disability index (NDI), a reliable instrument used in clinical practice, was used to assess patients' activities of daily living . It includes 10 items (pain intensity, personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation) each scored from 0 (no disability) to 5 (total disability). The total score is 50 , a higher score indicates a higher disability. The NDI is expressed by percentage. The Arabic version of NDI was delivered to patients.
Measured: Up to 6 months.
Psychological status assessment
The anxiety and depression profiles were assessed using the Hospital Anxiety and Depression scale (HAD). A validated Arabic version of the scale was used. The HAD includes 14 items (7 for anxiety and 7 for depression) rated from 0 to 3 each. The maximum score is 21 for each symptom, and a higher score indicates a poor psychological status . A score less than 7 indicates no depression or anxiety, a score of 8-10 indicates doubtful cases, and a score higher than 11 indicates a certain symptomatology.
Measured: Up to 6 months.
Quality of life (QoL)
The participants' QoL was assessed using the World Health Organization quality of life (WHOQOL-BREF) questionnaire with 4 domains: physical health, psychological, social relationships, and environment. Each domain is reported in percentages, with a higher score indicating better QoL, and a lower score indicating poor QoL.
Measured: Up to 6 months.
Kinesiophobia assessment
The Tampa Scale for Kinesiophobia (TSK) was used to evaluate the kinesiphobia. An Arabic version was administered to patients. The TSK includes 17 items rated from 1 to 4 each, with a total score ranging from 17 to 68. Higher scores reflect greater levels of movement-related fear, and a score higher than 37 indicates the presence of kinesiophobia.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start10 Feb 2023
- Primary completion21 Jun 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 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
- Investigators
- Anis Jellad, Professor, Principal investigator, University of Monastir, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727747
- Sponsor's protocol ID
- CTRB
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jellad A, Ben Salah Z, Boudokhane S, Migaou H, Bahri I, Rejeb N. The value of intermittent cervical traction in recent cervical radiculopathy. Ann Phys Rehabil Med. 2009 Nov;52(9):638-52. doi: 10.1016/j.rehab.2009.07.035. Epub 2009 Oct 8. English, French.
PubMed 19846359Jellad A, Kalai A, Abbes I, Jguirim M, Boudokhane S, Salah Frih ZB, Bedoui MH. The effect of cervical traction on stabilometric parameters in cervical radiculopathy patients: A randomized crossover study. J Back Musculoskelet Rehabil. 2024;37(4):1031-1040. doi: 10.3233/BMR-230270.
PubMed 38277282Jellad A, Dghim I, Nasrallah CB, Chaabeni A, Aqad AA, Kalai A, Jguirim M, Frih ZBS, Bedoui MH. Effect of cervical traction on balance parameters in patients with cervical radiculopathy: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 6;27(1):22. doi: 10.1186/s12891-025-09221-7.
PubMed 41350828
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Traction on Balance Parameters in Patients with Cervical Radiculopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06727747
- Acronym / sponsor ID
- CTRB
- Conditions
- Cervical Radiculopathy, Balance Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 11 Dec 2024 (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 randomized clinical trial aiming to assess the effect of cervical traction, using different loads, on balance parameters among patients with common cervical radiculopathy.
Authors hypothesized that as cervical traction alleviate radicular pain and improve function it may also improve patient balance parameters. Three different loads of traction are compared Main outcome measures are balance parameters (clinical and stabilometric). Patients are followed for during six months.
Detailed description
A randomized clinical trial was designed to assess the effect of cervical intermittent traction on balance parameters 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 three groups (A, B and C). Patients are treated with 2 Kg load intermittent cervical traction (A), 8 kg (B) and 12 kg (C). Patients in the three groups are treated additionnally with 12 rehabilitation sessions. Patients are assessed at baseline, at the end of the treatment (1 month), and at 3 and 6 months. Outcomes are mainly clinical balance assessment and stabilometry, and secondary, epidemiological parameters, pain intensity (VAS), cervical spine ROM and proprioception, grip strength, cervical spinal muscle strength, functional status (NDI), the psychological distress (HAD), and Quality of life All parameters are assessed at the Three follow-up points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Sham comparator | Other: Cervical traction, Other: RehabilitationPatients in group A recieved cervical traction with 2 kg load combined with standard rehabilitation program. This group is condidered as sham because the 2 kg load does not have any effect on anatomical structures of the cervical spine. |
| Group B | Active comparator | Other: Cervical traction, Other: RehabilitationPatients in group B recieved cervical traction with 8 kg load combined with standard rehabilitation program. The traction load in this group has an effect on muscular structures of the cervical spine without any actual effect on the remaining anatomical structures (intervertabral disks, joints and ligaments). |
| Group C | Experimental | Other: Cervical traction, Other: RehabilitationPatients in group C recieved cervical traction with 12 kg load combined with standard rehabilitation program. The traction load in this group has an actual effect on muscles, intervertabral disks, joints, and ligaments of the cervical spine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CR evolving for at least 3 months Well tolerated manual cervical traction test.
Key exclusion criteria (8 listed)
- Rehabilitation or chiropractic treatment for head or neck pain within the previous 3 months.
- neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance.
- Surgery or traumatic damage to the cervical spine.
- Ear, Nose and Throat pathology and ophthalmological disorders causing a balance disorder.
- Diabetes at the stage of neurovegetative complications
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 tractionAlso: Mechanical intermittent cervical tractionCervical traction procedure was performed using Saunders device. During the procedure, the patient lies in installed in a supine position with 20 degrees of cervical flexion and the physiotherapist gradually increases (5 minutes) the load to the defined kilograms which is maintained for 10 minutes then progressively decreases (5 minutes) the load to zero kilograms. The procedure is performed twice with a rest interval of 5 minutes. | Other | Group A, Group B, Group C |
| RehabilitationThe rehabilitation program compiled cervical spine mobilization, stretching of neck muscles and isometric strengthening exercises. Passive stretching of neck muscles groups was carried-out in a seated position with 3 repetition of 30 seconds each. Isometric strengthening exercises of neck extensors were performed in a seated position, against the resistance of the physiotherapist hand for 3 repetitions of 10 seconds each | Other | Group A, Group B, Group C |
Primary outcome
Stabilometric balance assessment 1
Time frame: Up to 6 months
Center of pressure of the foot sway area (Cop/SA) (mm ²)
Stabilometric balance assessment 2
Time frame: Up to 6 months
The lateral displacement length of the center of pressure of the foot (LD) (mm)
Stabilometric balance assessment 3
Time frame: Up to 6 months.
The anteroposterior displacement length of the center of pressure of the foot (AD) (mm)
Stabilometric balance assessment 4
Time frame: Up to 6 months
The lateral displacement velocity (LV) of the center of pressure of the foot (mm/s)
Stabilometric balance assessment 5
Time frame: Up to 6 months
The anteroposterior velocity (AV) of the dispalcement of the center of pressure of the foot(mm/s)
Clinical balance assessment
Time frame: Up to 6 months.
For the clinical balance assessment, the Brief-BESTest was used. Six categories included in the test (8 scored): 1. Biomechanical constraints: Hip strength 2. Stability limits/verticality: Reach forward 3. Anticipatory postural responses: Stand on one limb: left and right each scored 4. Postural responses: Compensatory Stepping right and left each scored 5. Sensory orientation: Stance on foam with eyes closed 6. Stability in gait: Get up and Go test Each item is scored: 0 - 3 points (0 representing severe impairment and 3 representing no balance impairment). Total score = 24 points (2 items include both a R/L component)
18 secondary outcomes
Sociodemographic characteristics 1
Time frame: Baseline.
Sociodemographic characteristics 2
Time frame: Baseline.
Sociodemographic characteristics 3
Time frame: Baseline.
Sociodemographic characteristics 4
Time frame: Baseline.
Sociodemographic characteristics 5
Time frame: Baseline.
Sociodemographic characteristics 6
Time frame: Baseline.
Duration of CR
Time frame: Baseline.
Side of CR
Time frame: Baseline.
Intensity of CR
Time frame: Baseline.
• Body Mass Index
Time frame: Baseline.
Cervical range of motion (ROM)
Time frame: Up to 6 months.
Cervical proprioception
Time frame: Up to 6 months.
Cervical muscles strength
Time frame: Up to 6 months.
Handgrip strength (HGS)
Time frame: Up to 6 months.
Neck disability assessment
Time frame: Up to 6 months.
Psychological status assessment
Time frame: Up to 6 months.
Quality of life (QoL)
Time frame: Up to 6 months.
Kinesiophobia assessment
Time frame: Baseline.
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 11 Dec 2024.
- Background: PubMed 19846359Jellad A, Ben Salah Z, Boudokhane S, Migaou H, Bahri I, Rejeb N. The value of intermittent cervical traction in recent cervical radiculopathy. Ann Phys Rehabil Med. 2009 Nov;52(9):638-52. doi: 10.1016/j.rehab.2009.07.035. Epub 2009 Oct 8. English, French.
- Background: PubMed 38277282Jellad A, Kalai A, Abbes I, Jguirim M, Boudokhane S, Salah Frih ZB, Bedoui MH. The effect of cervical traction on stabilometric parameters in cervical radiculopathy patients: A randomized crossover study. J Back Musculoskelet Rehabil. 2024;37(4):1031-1040. doi: 10.3233/BMR-230270.
- Derived from this study: PubMed 41350828Jellad A, Dghim I, Nasrallah CB, Chaabeni A, Aqad AA, Kalai A, Jguirim M, Frih ZBS, Bedoui MH. Effect of cervical traction on balance parameters in patients with cervical radiculopathy: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 6;27(1):22. doi: 10.1186/s12891-025-09221-7.
- Individual participant dataSharing planned: Undecided
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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.
Anis Jellad, Professor principal investigator
University of Monastir, Faculty of Medicine
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 and Rehabilitation in people with Cervical Radiculopathy and Balance Disorders, 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 8 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 11 Dec 2024. 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?
Stabilometric balance assessment 1 (time frame: Up to 6 months). The study lists 6 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 NCT06727747, which also lists 3 linked publications.
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 11 Dec 2024.