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

University of Peradeniya

Status: Not yet enrolling

Conditions: Cervical Radiculopathy

Treatments: Procedure: 1.Isometric exercise 2.combined conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06276699

FAHS

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups, including a placebo group

1.Isometric exercise

Placebo Comparator group

Treatment:

Procedure: 1.Isometric exercise 2.combined conservative treatment

2. Combined conservative treatment

Experimental group

Treatment:

Procedure: 1.Isometric exercise 2.combined conservative treatment