Assessment and Rehabilitation in Cervical Radiculopathy

NCT07054450 | Enrolling By Invitation DMC

• 1 other identifier: FilantropiaH
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

cervical radiculopathy; physical medicine and rehabilitation; quality of life; nutraceutical treatment

Outcome Measures

Primary Outcomes (2)

• Neck Disability Index

  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

  3 months

• Visual Analogue Scale For Pain

  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.

  3 months

Secondary Outcomes (1)

• Improving quality of life- Katz Index of Independence in Activities of Daily Living

  3 months

Study Arms (2)

Study Group

EXPERIMENTAL

Study Group will receive 10 sessions of rehabilitation program and nutraceutical product daily for 3 months.

Combination Product: All patients in the study will be included in rehabilitation program; Dietary Supplement: Study Group will receive a nutraceutical product daily, 3 months.

Control Group

ACTIVE COMPARATOR

Control Group will receive 10 sessions of rehabilitation program.

Combination Product: All patients in the study will be included in rehabilitation program

Interventions

All patients in the study will be included in rehabilitation program COMBINATION_PRODUCT

A total of 110 consecutive participants with previous diagnosed CR lasting more than 3 months will be enrolled in this study. After initial assessment, participants without surgical recommendation, will be included into two groups: Study Group will be received 10 sessions of rehabilitation program and nutraceutical product daily, 3 months, and Control Group will be received 10 sessions of rehabilitation program. The rehabilitation program include physical therapy (electrical muscle stimulation of the neck muscle and upper limb muscles , low-Level Laser Therapy and ultrasound) and kinetic training.

Control Group; Study Group

Study Group will receive a nutraceutical product daily, 3 months. DIETARY_SUPPLEMENT

Study Group will receive a nutraceutical product daily, 3 months in addition to the rehabilitation program.

Study Group

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Filantropia Hospital: lead

Study Sites (1)

Diana Kamal

Craiova, 1100, Romania

Location

MeSH Terms

Conditions

Spondylarthritis; Radiculopathy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Study Group will be receiving a nutraceutical product daily, for 3 months,

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 8, 2025
• Study Start: May 10, 2025
• Primary Completion: May 14, 2025
• Study Completion: August 15, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

RO (1)