Assessment and Rehabilitation in Cervical Radiculopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: All patients in the study will be included in rehabilitation program, Study Group will receive a nutraceutical product daily, 3 months..
- Who it may be relevant to
- Registry conditions: Cervical Radicular Pain, Spondyloarthritis (SA), Neuropathic Pain Management, Quality of Life (QOL). Basic parameters: 50 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient With Cervical Radiculopathy - Complete Assessment and Rehabilitation
Overview
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
Interventions
- Combination product 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 o - Dietary supplement 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.
Primary outcome measures
- Neck Disability Index [Time frame: 3 months]
- Visual Analogue Scale For Pain [Time frame: 3 months]
Secondary outcome measures (1)
- Improving quality of life- Katz Index of Independence in Activities of Daily Living [Time frame: 3 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Romania · 1 center
- Diana Kamal — Craiova
Identifiers
NCT: NCT07054450 · FilantropiaH