Effect of Cervical Traction on Balance in Cervical Radiculopathy

NCT06727747 | Completed

• 1 other identifier: CTRB
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. Three different loads of traction are compared Main outcome measures are balance parameters (clinical and stabilometric). Patients are followed for during six months.

Conditions

Cervical Radiculopathy; Balance Disorders

Outcome Measures

Primary Outcomes (6)

• Stabilometric balance assessment 1

  Center of pressure of the foot sway area (Cop/SA) (mm ²)

  Up to 6 months

• Stabilometric balance assessment 2

  The lateral displacement length of the center of pressure of the foot (LD) (mm)

  Up to 6 months

• Stabilometric balance assessment 3

  The anteroposterior displacement length of the center of pressure of the foot (AD) (mm)

  Up to 6 months.

• Stabilometric balance assessment 4

  The lateral displacement velocity (LV) of the center of pressure of the foot (mm/s)

  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)

  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): 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)

  Up to 6 months.

Secondary Outcomes (18)

• Sociodemographic characteristics 1

  Baseline.

• Sociodemographic characteristics 2

  Baseline.

• Sociodemographic characteristics 3

  Baseline.

• Sociodemographic characteristics 4

  Baseline.

• Sociodemographic characteristics 5

  Baseline.

Study Arms (3)

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.

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).

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.

Other: Cervical traction; Other: Rehabilitation

Interventions

Cervical traction OTHER

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.

Also known as: Mechanical intermittent cervical traction

Group A; Group B; Group C

Rehabilitation OTHER

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CR evolving for at least 3 months Well tolerated manual cervical traction test.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Faculty of Medicine of Monastir

Monastir, 5000, Tunisia

Location

Related Publications (2)

• 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.

  PMID: 19846359 BACKGROUND

• Jellad 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.

  PMID: 38277282 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anis Jellad, Professor

  University of Monastir, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinician who screened patients for eligibility
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: December 11, 2024
• Study Start: February 10, 2023
• Primary Completion: June 21, 2023
• Study Completion: December 30, 2023
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

TU (1)