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Clinical Trials/NCT06276699
NCT06276699
Not Yet Recruiting
N/A

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

University of Peradeniya0 sites46 target enrollmentApril 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervical Radiculopathy
Sponsor
University of Peradeniya
Enrollment
46
Primary Endpoint
Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline.
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2024
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

T.Neeraja

Physiotherapist, Principal Investigator

University of Peradeniya

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
  • Whiplash injury
  • Pregnancy woman
  • Rheumatoid arthritis
  • Post-surgery to cervical/thoracic spine

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)
  • 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)

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