Cervical Radicular PainNCT07054450
Assessment and Rehabilitation in Cervical Radiculopathy
A study testing All patients in the study will be included in rehabilitation program and Study Group will receive a nutraceutical product daily, 3 months. in people with Cervical Radicular Pain and Spondyloarthritis (SA), run by Filantropia Hospital at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Cervical Radicular Pain, Spondyloarthritis (SA), Neuropathic Pain Management
- What is being tested?
- All patients in the study will be included in rehabilitation program and Study Group will receive a nutraceutical product daily, 3 months.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRomania
- Study dates
- 10 May 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient With Cervical Radiculopathy - Complete Assessment and Rehabilitation
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)
- Being tested
- All patients in the study will be included in rehabilitation program, Study Group will receive a nutraceutical product daily, 3 months.
- Keywords
- cervical radiculopathy, physical medicine and rehabilitation, quality of life, nutraceutical treatment
- Medical subject headings
- Spondylarthritis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients in the study will be included in rehabilitation programCombination 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.Dietary supplement
Study Group will receive a nutraceutical product daily, 3 months in addition to the rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Study Group will receive 10 sessions of rehabilitation program and nutraceutical product daily for 3 months. Receives: 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. Receives: Combination Product: All patients in the study will be included in rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months
Secondary outcomes (1)
Improving quality of life- Katz Index of Independence in Activities of Daily Living
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start10 May 2025
- Primary completion14 May 2025
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Radicular PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Group will be receiving a nutraceutical product daily, for 3 months,
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filantropia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Kamal, Filantropia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054450
- Sponsor's protocol ID
- FilantropiaH
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient With Cervical Radiculopathy - Complete Assessment and Rehabilitation
- ClinicalTrials.gov ID
- NCT07054450
- Acronym / sponsor ID
- FilantropiaH
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Filantropia HospitalUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study Group will be receiving a nutraceutical product daily, for 3 months,
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | 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 Group will receive 10 sessions of rehabilitation program and nutraceutical product daily for 3 months. |
| Control Group | Active comparator | Combination Product: All patients in the study will be included in rehabilitation programControl Group will receive 10 sessions of rehabilitation program. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All patients in the study will be included in rehabilitation programA 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. | Combination product | Control Group, Study Group |
| 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. | Dietary supplement | Study Group |
Primary outcome
Neck Disability Index
Time frame: 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
Time frame: 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.
1 secondary outcome
Improving quality of life- Katz Index of Independence in Activities of Daily Living
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All patients in the study will be included in rehabilitation program and Study Group will receive a nutraceutical product daily, 3 months. in people with Cervical Radicular Pain and Spondyloarthritis (SA), run by Filantropia Hospital at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.