Cervical Radicular Pain, Neuropathic Pain Management, Quality of Life (QOL), Spondyloarthritis (SA)
Conditions
Keywords
cervical radiculopathy, physical medicine and rehabilitation, quality of life, nutraceutical treatment
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
Interventions
COMBINATION_PRODUCTAll 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.
DIETARY_SUPPLEMENTStudy 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.
Sponsors
Filantropia Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Study Group will be receiving a nutraceutical product daily, for 3 months,
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Romania
Outcome results
None listed