Assessment and Rehabilitation in Cervical Radiculopathy

Filantropia Hospital

Status: Invitation-only

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

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT07054450

FilantropiaH

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Study Group

Experimental group

Description:

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

Treatment:

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

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

Control Group

Active Comparator group

Description:

Control Group will receive 10 sessions of rehabilitation program.

Treatment:

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