Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy
- Conditions
- Cervical Radiculopathy
- Interventions
- Procedure: 1.Isometric exercise 2.combined conservative treatment
- Registration Number
- NCT06276699
- Lead Sponsor
- University of Peradeniya
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 46
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1.Isometric exercise 1.Isometric exercise 2.combined conservative treatment - 2. Combined conservative treatment 1.Isometric exercise 2.combined conservative treatment -
- Primary Outcome Measures
Name Time Method Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline. 2 times a week for 6 weeks 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
- Secondary Outcome Measures
Name Time Method 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 Neck disability index (NDI) will be used to measure the patient's level of disability
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 Measured by using a goniometer