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

NCT06276699 | Not Yet Recruiting

• 1 other identifier: FAHS
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline.

  Visual analog scale (VAS) is a measurement tool used in order to measure the pain Zero indicates no pain and 10 indicates maximum pain that patient feels

  2 times a week for 6 weeks

Secondary Outcomes (2)

• Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline.

  2 times a week for 6 weeks

• Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline

  2 times a week for 6 weeks

Study Arms (2)

1.Isometric exercise

PLACEBO COMPARATOR

Procedure: 1.Isometric exercise 2.combined conservative treatment

2. Combined conservative treatment

EXPERIMENTAL

Procedure: 1.Isometric exercise 2.combined conservative treatment

Interventions

1.Isometric exercise 2.combined conservative treatment 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.

Also known as: Conservative management (Cervical traction, Neural mobilization)

1.Isometric exercise; 2. Combined conservative treatment

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Peradeniya: lead

MeSH Terms

Conditions

Radiculopathy

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Principal Investigator

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 26, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04