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

Cervical Radiculopathy Clinical Trial

Official title:

Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy - A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276699
• Other study ID #: FAHS
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: University of Peradeniya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Peradeniya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline.	Measured by using a goniometer	2 times a week for 6 weeks
Secondary	Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline	Neck disability index (NDI) will be used to measure the patient's level of disability	2 times a week for 6 weeks