SpondyloarthropathyNCT06252064
Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain
A study testing Rehabilitation + Drug therapy, Rehabilitation and Drug therapy in people with Spondyloarthropathy, run by University of Palermo at 1 site in Italy.
Trial summary
Spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral bodies, and adjacent soft tissues. Treatment aims to slow disease progression and manage symptoms through an interdisciplinary approach.It can be conservative, pharmacological and interventional, rarely chirurgic. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Spondyloarthropathy
- What is being tested?
- Rehabilitation + Drug therapy, Rehabilitation and Drug therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65-75 years,
- low back pain for at least 3 months,
- NRS ≥ 4,
- radiographic diagnosis of spondyloarthrosis,
- written informed consent.
Who cannot join
- inflammatory diseases of the spine,
- obesity (BMI 20-30),
- positive radicular tests,
- allergy or contraindications related to taking Pridinol Mesylate.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Palermo, 90127
About this study
Spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral bodies, and adjacent soft tissues. Treatment aims to slow disease progression and manage symptoms through an interdisciplinary approach.It can be conservative, pharmacological and interventional, rarely chirurgic. This study aimed to evaluate the effectiveness of a rehabilitation program combined with Pridinol Mesylate in the treatment of Spondyloarthrosis in elderly patients in terms of pain resolution, improving disability, and quality of life versus single treatment.
A randomized controlled trial was conducted in patients with spondyloarthritis. The patients recruited were divided into three groups: the Combined Group (CG), who received a rehabilitation program combined with Pridinol Mesylate; the Rehabilitation Group (RG), who received only the same rehabilitation program; and the Drug Group (DG), who received only the administration of the drug.
- Conditions
- Spondyloarthropathy
- Being tested
- Rehabilitation + Drug therapy, Rehabilitation, Drug therapy
- Keywords
- Spondylarthropathies, Pridinol Mesilate, Low Back Pain, Rehabilitation, Therapy
- Medical subject headings
- Spondylarthropathies, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation + Drug therapyOther
Patients in the Combo group underwent rehabilitation treatment combined with drug therapy: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. Patients included in this group also took drug therapy, particularly Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days.
RehabilitationOther
Patients in the Reha group underwent rehabilitation treatment: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. The treatment included an initial step, lasting 40 minutes, of Postural Reeducation ending with Stretching exercises of the posterior kinetic chain muscles lasting 20 minutes.
Drug therapyOther
The Drug Group had taken Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days. The tablet was taken without chewing and with a glass of water (200 ml). The drug was taken in environments with temperature below 25° C.
| Study group | Role | What they receive |
|---|---|---|
| Combo Group | Active comparator | Rehabilitation treatment combined with drug therapy Receives: Other: Rehabilitation + Drug therapy |
| Reha Group | Active comparator | Rehabilitation treatment Receives: Other: Rehabilitation |
| Drug Group | Active comparator | Drug therapy with Pridinol Mesylate Receives: Other: Drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of pain: Numeric Rating Scale (NRS 0-10)
The NRS is a subjective scale that rates the extent of pain with a score between 0 and 10; a score of 10 corresponds to maximum pain.
Measured: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
Secondary outcomes (2)
Quality of life: Short Form Health Survey 36 (0-100)
SF-36 is a scale that assesses the quality of life in relation to the disease from which patients suffer. A score of 100 corresponds to an optimal value.
Measured: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100)
is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain. These outcomes score within the range of 0 and 100, determents the level of functional disability, with higher numbers representing greater levels of disability.
Measured: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Mar 2022
- Primary completion30 Jun 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthropathyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
- Investigators
- Giulia Letizia Mauro, Principal investigator, A.O.U.P. Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252064
- Sponsor's protocol ID
- MFR022024
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
PubMed 28192789Uberall MA, Muller-Schwefe GHH, Horlemann J. Efficacy and tolerability of the antispasmodic, pridinol, in patients with muscle-pain - results of primepain, a retrospective analysis of open-label real-world data provided by the German pain E-registry. Curr Med Res Opin. 2022 Jul;38(7):1203-1217. doi: 10.1080/03007995.2022.2077579. Epub 2022 Jun 1.
PubMed 35575167Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
PubMed 29971708
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06252064
- Acronym / sponsor ID
- MFR022024
- Conditions
- Spondyloarthropathy
- Keywords
- Spondylarthropathies, Pridinol Mesilate, Low Back Pain, Rehabilitation, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 9 Feb 2024 (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.
Spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral bodies, and adjacent soft tissues. Treatment aims to slow disease progression and manage symptoms through an interdisciplinary approach.It can be conservative, pharmacological and interventional, rarely chirurgic. This study aimed to evaluate the effectiveness of a rehabilitation program combined with Pridinol Mesylate in the treatment of Spondyloarthrosis in elderly patients in terms of pain resolution, improving disability, and quality of life versus single treatment.
A randomized controlled trial was conducted in patients with spondyloarthritis. The patients recruited were divided into three groups: the Combined Group (CG), who received a rehabilitation program combined with Pridinol Mesylate; the Rehabilitation Group (RG), who received only the same rehabilitation program; and the Drug Group (DG), who received only the administration of the drug.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combo Group | Active comparator | Other: Rehabilitation + Drug therapyRehabilitation treatment combined with drug therapy |
| Reha Group | Active comparator | Other: RehabilitationRehabilitation treatment |
| Drug Group | Active comparator | Other: Drug therapyDrug therapy with Pridinol Mesylate |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age 65-75 years,
- low back pain for at least 3 months,
- NRS ≥ 4,
- radiographic diagnosis of spondyloarthrosis,
- written informed consent.
Key exclusion criteria (4 listed)
- inflammatory diseases of the spine,
- obesity (BMI 20-30),
- positive radicular tests,
- allergy or contraindications related to taking Pridinol Mesylate.
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 |
|---|---|---|
| Rehabilitation + Drug therapyPatients in the Combo group underwent rehabilitation treatment combined with drug therapy: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. Patients included in this group also took drug therapy, particularly Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days. | Other | Combo Group |
| RehabilitationPatients in the Reha group underwent rehabilitation treatment: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. The treatment included an initial step, lasting 40 minutes, of Postural Reeducation ending with Stretching exercises of the posterior kinetic chain muscles lasting 20 minutes. | Other | Reha Group |
| Drug therapyThe Drug Group had taken Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days. The tablet was taken without chewing and with a glass of water (200 ml). The drug was taken in environments with temperature below 25° C. | Other | Drug Group |
Primary outcome
Extent of pain: Numeric Rating Scale (NRS 0-10)
Time frame: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
The NRS is a subjective scale that rates the extent of pain with a score between 0 and 10; a score of 10 corresponds to maximum pain.
2 secondary outcomes
Quality of life: Short Form Health Survey 36 (0-100)
Time frame: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100)
Time frame: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 28192789Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Background: PubMed 35575167Uberall MA, Muller-Schwefe GHH, Horlemann J. Efficacy and tolerability of the antispasmodic, pridinol, in patients with muscle-pain - results of primepain, a retrospective analysis of open-label real-world data provided by the German pain E-registry. Curr Med Res Opin. 2022 Jul;38(7):1203-1217. doi: 10.1080/03007995.2022.2077579. Epub 2022 Jun 1.
- Background: PubMed 29971708Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
- 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. This study is not recruiting at the moment.
Giulia Letizia Mauro principal investigator
A.O.U.P. Paolo Giaccone Palermo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation + Drug therapy, Rehabilitation and Drug therapy in people with Spondyloarthropathy, run by University of Palermo at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 9 Feb 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extent of pain: Numeric Rating Scale (NRS 0-10) (time frame: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06252064, which also lists 3 linked publications.
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 9 Feb 2024.