Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy

NCT ID: NCT06276699

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-06-30

Brief Summary

This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1.Isometric exercise

Group Type: PLACEBO_COMPARATOR

1.Isometric exercise 2.combined conservative treatment

Intervention Type: PROCEDURE

Exercise programs will be taught to patients with details by an experienced physiotherapist at the beginning of the study. Cervical Traction Patient will sit upright posture on a chair. Mechanical traction will be applied. It includes placement of a halo device around the neck, then the harness will be attached to the machine that applies traction force through-out the treatment, the device is controlled by the control panel. Intermittent mechanical traction will be applied for 10 minutes in which pull for 10 seconds and 5 seconds rest will be applied. Neural mobilization will be carried out using Butler's approach. The subject will be positioned in supine, and the median nerve will be mobilized using a slider.

2. Combined conservative treatment

Group Type: EXPERIMENTAL

1.Isometric exercise 2.combined conservative treatment

Intervention Type: PROCEDURE

Exercise programs will be taught to patients with details by an experienced physiotherapist at the beginning of the study. Cervical Traction Patient will sit upright posture on a chair. Mechanical traction will be applied. It includes placement of a halo device around the neck, then the harness will be attached to the machine that applies traction force through-out the treatment, the device is controlled by the control panel. Intermittent mechanical traction will be applied for 10 minutes in which pull for 10 seconds and 5 seconds rest will be applied. Neural mobilization will be carried out using Butler's approach. The subject will be positioned in supine, and the median nerve will be mobilized using a slider.

Interventions

1.Isometric exercise 2.combined conservative treatment

Exercise programs will be taught to patients with details by an experienced physiotherapist at the beginning of the study. Cervical Traction Patient will sit upright posture on a chair. Mechanical traction will be applied. It includes placement of a halo device around the neck, then the harness will be attached to the machine that applies traction force through-out the treatment, the device is controlled by the control panel. Intermittent mechanical traction will be applied for 10 minutes in which pull for 10 seconds and 5 seconds rest will be applied. Neural mobilization will be carried out using Butler's approach. The subject will be positioned in supine, and the median nerve will be mobilized using a slider.

Intervention Type: PROCEDURE

Other Intervention Names

Conservative management (Cervical traction, Neural mobilization)

Eligibility Criteria

Inclusion Criteria

• 35-60 years
• Neck pain > 3 months
• Clinical Prediction Rules - Positive Spurling's test (+) Distraction test (+) Upper limb tension test A (+) Cervical rotation on affected side < 60

Exclusion Criteria

Presence of any signs or symptoms of medical red flags

• Less than 3(positive) items for the CPR
• Bilateral arm radiating pain
• Osteoporosis
• Tumor
• Whiplash injury
• Pregnancy woman
• Rheumatoid arthritis
• Post-surgery to cervical/thoracic spine

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Peradeniya

OTHER

Sponsor Role: lead

Responsible Party

T.Neeraja

Physiotherapist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FAHS

Identifier Type: -

Identifier Source: org_study_id