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NCT Number: NCT04598113

Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

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).

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Key information

Conditions

Cervical Radiculopathy Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine and rehabilitation Department

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral cervical radiculopathy of greater than three months

Exclusion criteria

  • 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

Treatment and study plan

Cervical Traction Device

Device

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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.

  5. 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)

Secondary outcomes

  1. Change in pain intensity

    Time frame: The pain assessement is done just before the intervention and 5 minutes after

    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.

  2. Change in grip strength (Kg)

    Time frame: The measure is done just before the intervention and 5 minutes after

    The grip strength is measured using Jamar Hydraulic Hand Dynamometer

Other outcomes

  1. The Brief Best test

    Time frame: The test is performed only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.

    Clinical test to assess the balance capacity during standing and walking.

  2. Neck Disability Index (NDI)

    Time frame: The questionnaire is administered only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.

    A self-administered questionnaire used to assess the self-rated disability. It contains 10 sections scored from 0 to 5 each. The total score range from 0 to 50. The higher the score the higher the patient's level of disability.

  3. Hospital Anxiety and Depression scale

    Time frame: The scale is administered only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.

    A scale used to determine the level of anxiety and depression in patients. The questionnaire comprises seven questions for anxiety and seven questions for depression. Each response to a question is scored from 0 to 3. The total score for anxiety and depression separately range from 0 to 21. The higher the score the more sever the patient's anxiety and depression status.

  4. The short form (36) health survey: SF-36

    Time frame: The questionnaire is administered only once at baseline in each patient: before the Effective Traction in the Arm EffectiveTraction/ShamTraction and before the Sham Traction in the Arm ShamTraction/EffectiveTraction.

    A questionnaire used to assess patient's health status (Quality of life). It yields an 8-scale profile of functional health and well-being scores: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), mental health (MH), and one single item scale on health transition. Score ranges from 0 to 100, with higher score indicating higher level of function and/or better health and lower score indicating lower level of function and/or bad health.

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

The Immediate Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients: A Randomized Cross-over Trial)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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