Assessment and Rehabilitation in Cervical Radiculopathy

NCT ID: NCT07054450

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2025-08-15

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

All patients in the study will be included in rehabilitation program

Intervention Type: 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.

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

Intervention Type: DIETARY_SUPPLEMENT

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

Control Group

Control Group will receive 10 sessions of rehabilitation program.

Group Type: ACTIVE_COMPARATOR

All patients in the study will be included in rehabilitation program

Intervention Type: 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.

Interventions

All patients in the study will be included in rehabilitation program

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.

Intervention Type: COMBINATION_PRODUCT

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

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Filantropia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Diana Kamal

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diana Kamal

Craiova, , Romania

Countries

Romania

Other Identifiers

FilantropiaH

Identifier Type: -

Identifier Source: org_study_id