Assessment and Rehabilitation in Cervical Radiculopathy

Not Applicable

• Conditions: Neuropathic Pain Management; Quality of Life (QOL); Cervical Radicular Pain; Spondyloarthritis (SA)

• Registration Number: NCT07054450
• Lead Sponsor: Filantropia Hospital

Brief Summary

The investigators perform a prospective controlled study and analyse the effects of a rehabilitation program, including oral anti-inflammatory drugs, nutraceutical - ProHumano+ SpineDinamic (PHSD), physical therapy and kinetic measures on reduction of the severity of radicular pain, and improvement of the quality of life in participants with cervical radiculopathy (CR) over a relatively short period of treatment (three months).

The major tasks in the assessment and management of CR are to exclude signs and/or symptoms of possible serious underlying pathology, to focus on an active approach to promote the natural recovery and to prevent chronicity through early tailored rehabilitation

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-10
• Primary Completion: 2025-05-14
• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• patients older than 50 years of age;
• lasting more than 3 months and diagnosed with CR confirmed by MRI in the last 6 months;
• absence of other significant and disability upper limb osteoarthritis;
• patients with stable cardiovascular and respiratory function, without unstable medical conditions;
• compliance with physical exercise during the healthcare program.

Exclusion Criteria

• pregnancy or breastfeeding;
• need for surgical treatment;
• intolerance to any component of the nutraceutical product;
• malignancy;
• modified laboratory test (ALT, AST, or Urea >2x% reference range, Creatinine >3x% reference range).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	3 months	Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Score: /50 Transform to percentage score x 100 = %points Scoring: For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated Minimum Detectable Change (90% confidence): 5 points or 10 %points
Visual Analogue Scale For Pain	3 months	The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Values close to 100 show a maximum value of pain, and 0 the absence of pain.

Secondary Outcome Measures

Name	Time	Method
Improving quality of life- Katz Index of Independence in Activities of Daily Living	3 months	The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the participants ability to perform activities of daily living independently. Investigators typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Participants are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.

Trial Locations

Locations (1)

Diana Kamal; 🇷🇴 Craiova, Romania