Osteoarthritis, KneePhase 4PERIPATEINCT05761015
Helping Osteoarthritis Patients to Walk With NSAID
A Phase 4 study testing therapeutic program including intermittent drug intake and multimodal rehabilitation program in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
There is a lack of effective analgesic treatments to help walking patients with painful hip/knee osteoarthritis. Our team therefore imagined a new strategy lying on a multimodal rehabilitation walking program with the help of a transient intake of nonsteroidal anti-inflammatory drug (NSAID). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Chronic Pain
- What is being tested?
- therapeutic program including intermittent drug intake and multimodal rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2023to Apr 2028
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uni- or bilateral hip or knee idiopathic osteoarthrosis (ACR criteria, Kellgren-Lawrence grade 2 or more on recent X-ray), responsible for pain since 3 at least months, and pain at walking which intensity is at least 4/10 on a numerical rating scale.
- Less than 3 relevant walks (at least 20 minutes or 1000 km) a week.
- Ability to understand and to follow the protocol, and to answer the questionnaires
Who cannot join
- Pregnancy or breastfeeding
- Legal protection
- Body weight < 40 kg or underweight
- Body weight >120 kg or obesity
- Unability to walk, or unability to walk without support devices (sticks, crutches, orthoses and knee pads are allowed)
- Secondary osteoarthrosis (rheumatism, septic arthritis, recent osteonecrosis, hemochromatosis, gout, acromegalia…).
Show all 20Show fewer
- Concomitant general bone disease (Paget, Reiter…).
- Concomitant and relevant painful disease else than due to osteoarthrosis (e.g. neuropathic pain, fibromyalgia…)
- Previous recent intervention (e.g. surgery, arthroscopy, joint infiltration) expected to relief osteoarthrosis pain throughout the study period.
- Planned intervention similar to those abovementioned, during the study period.
- Recent initiation of any new analgesic treatment (including systemic steroids).
- Planned initiation of any program expected to relief osteoarthrosis pain during the study period, such as physiotherapy, cognitive behavioral therapy…).
- Planned major surgery during the study period.
- Current cancer disease.
- Immunosuppression.
- Autoimmune disease.
- Concomitant topical or systemic NSAID treatment.
- Chronic strong opioid intake.
- Concomitant insulin therapy.
- Any absolute or relevant contraindication to NSAIDs or acetaminophen, according to the French drug agency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clemront-Ferrand
Clermont-Ferrand
Lise Laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Christian DUALE
About this study
Official title: A Rehabilitation Walking Program With the Help of a Transient Intake of Nonsteroidal Anti-inflammatory Drug for Patients With Painful Hip/Knee Osteoarthritis - A Pilot Cohort Study With Objectives of Short Walks in the Real Life.
There is a lack of effective analgesic treatments to help walking patients with painful hip/knee osteoarthritis. Our team therefore imagined a new strategy lying on a multimodal rehabilitation walking program with the help of a transient intake of nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are indeed known to act specifically on pain at movement, but their continuous intake would induce unacceptable side effects. To optimize the benefit/risk balance, the molecule to be chosen must fit to the patient's profile, and its intake should cover only the period of interest, i.e. planned walks. Our multimodal rehabilitation program will also include physical techniques such as appropriate footwear, a patient's education aiming at reducing fear/avoidance and spotting side effects of NSAIDs, and a prescription frame to avoid any overdosing.
This clinical study is a single-center, non-randomized, open label, one-arm trial, using drugs prescribed according to their label (i.e. osteoarthritis pain), pending a reinforced monitoring of side effects.
Read more
The primary endpoint is to evaluate efficacy and tolerance of a tailored and transient administration of NSAID within a rehabilitation walking program in patients with painful hip/knee osteoarthritis.
Secondary endpoints are to evaluate the adherence to the program and the factors influencing adherence; to identify the less well tolerated conditions of treatment (one condition being one molecule for one patient profile); to identify the factors of success among a set of baseline demographic, morphometric and psychometric variables; and to study the role of central sensitization (assessed by temporal summation) on the efficacy of treatment.
Read the detailed description
Study schedule:
- Inclusion visit (V0): check of the eligibility criteria, explanation of the protocol, plan for a podiatric consultation, baseline questionnaires, and delivery of diary to collect efficacy outcomes.
- Observation time (4 weeks): baseline measurement of efficacy outcomes (physical activity and pain at walk), podiatric consultation and improvement of footwear (including orthosis or soles).
- Pre-intervention visit (V1) : collection of self-reported outcomes, measurement of temporal summation, 6-min walk test before and after NSAID test *, plan for the first 6-week intervention period and delivery of diary to collect efficacy and tolerance outcomes.
- Intermediate within-intervention visit (after 6 weeks): collection of self-reported outcomes, blood sampling (biological tolerance outcomes), plan for the second 6-week intervention period and delivery of diary to collect efficacy and tolerance outcomes.
- End-of-study visit: collection of self-reported outcomes, blood sampling (biological tolerance outcomes), and collection of last efficacy outcomes (anxiety, depression, kinesiophobia, global impression of change).
- The patient will undergo two 6-min walk tests at the pre-intervention visit, one before and one 45 min. after oral administration of the NSAID. The patient will be considered as responsive to the NSAID if one of the following criteria occurs: a 15% increase (or more) of the time-to-first pain at walk, self-defined as bothering; a 1-point decrease (or more) of pain intensity (out of 10) throughout the test; or a 15% increase (or more) of the walked distance, if this was < 200 m at the first test. Only patients responsive to the NSAID will continue the trial.
The sequence of successes will be treated in Bayesian analyses. Sequential analyses with be conducted stepwise. At each step, the decision to stop or to keep going will be taken, until a maximum of 50 cases eligible for analysis.
- 1st step (N=20): stop for efficacy if more than 11 successes; stop for non-efficacy if less than 6 successes; continuation otherwise (20 supplementary patients);
- 2nd step (N=40): stop for efficacy if more than 17 successes; stop for non-efficacy if less than 16 successes; continuation otherwise (20 supplementary patients);
- 3rd step (N=50): efficacy if more than 21 successes; non-efficacy otherwise
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Chronic Pain
- Being tested
- therapeutic program including intermittent drug intake and multimodal rehabilitation program
- Keywords
- Osteoarthritis, Knee, Osteoarthritis, Hip, pain at movement, nonsteroidal anti-inflammatory drug, acetaminophen, paracetamol, personalized medicine, pharmacovigilance
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic program including intermittent drug intake and multimodal rehabilitation programDrug
The prescribed NSAID molecule shall be chosen according to the patient's risk profile:
- gastric/duodenal risk: age >65, history of ulcer with remission, history of inflammatory event, current low-dose acetylsalicylic acid treatment ;
- cardiovascular risk (according to Agostino scale \& SCORE);
The molecule with therefore be:
- no risk: niflumic acid, 250 mg per intake;
- gastric/duodenal risk only: diclofenac, 50-100 mg per intake, plus lansoprazole;
- cardiovascular risk only: ketoprofen, 50-100 mg per intake;
- double risk: ibuprofen, 200-400 mg per intake, plus lansoprazole. For the walk test, the highest dose of diclofenac or ketoprofen will be used. Then, the patient will be free to half the dose if pain relief is achieved so.
One gram of acetaminophen will be added to any NSAID intake. The number of intakes will be limited to twice a day (morning and evening) and to 10 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | there is only one intervention arm and no control arm; the Bayesian analysis will be conducted under hypothetical estimates of superiority vs. control. Receives: Drug: therapeutic program including intermittent drug intake and multimodal rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
success of the therapeutic program (defined by a 30%-increase (or more) of the monthly number of target moves from the baseline observation values, with no treatment discontinuation for NSAID side effects)
Measured: V1 (pre-intervention visit) + 12 weeks
Secondary outcomes (13)
Self-declared physical activity (efficacy outcome)
Global Physical Activity Questionnaire (GPAQ)
Measured: V1 (pre-intervention visit)
Self-declared physical activity (efficacy outcome)
Global Physical Activity Questionnaire (GPAQ)
Measured: V1 (pre-intervention visit) + 6 weeks
Self-declared physical activity (efficacy outcome)
Global Physical Activity Questionnaire (GPAQ)
Measured: V1 (pre-intervention visit) + 12 weeks
Actual physical activity (efficacy outcome)
Number of steps per day assessed by pedometer
Measured: V1 (pre-intervention visit)
Actual physical activity (efficacy outcome)
Number of steps per day assessed by pedometer
Measured: V1 (pre-intervention visit)+ 6 weeks
Actual physical activity (efficacy outcome)
Number of steps per day assessed by pedometer
Measured: V1 (pre-intervention visit) + 12 weeks
Pain at walk during the two last weeks (efficacy outcome)
Visual Analogic Scale VAS (11-point numerical rating scale (from 0 = "no pain" to 10) "the worst pain imaginable")
Measured: V1 (pre-intervention visit)
Pain at walk during the two last weeks (efficacy outcome)
Visual Analogic Scale VAS (11-point numerical rating scale (from 0 = "no pain" to 10) "the worst pain imaginable")
Measured: V1 (pre-intervention visit) + 6 weeks
Pain at walk during the two last weeks (efficacy outcome)
Visual Analogic Scale VAS (11-point numerical rating scale (from 0 = "no pain" to 10) "the worst pain imaginable")
Measured: V1 (pre-intervention visit)+ 12 weeks
Patient's Global Impression of Change (efficacy outcome)
7-item scale
Measured: V1 (pre-intervention visit) + 12 weeks
kinesiophobia (efficacy outcome)
Tampa Scale of Kinesiophobia (TSK)
Measured: V1 (pre-intervention visit) + 12 weeks
level of anxious state (efficacy outcome)
Hospital Anxiety and Depression scale (HADS)
Measured: V1 (pre-intervention visit) + 12 weeks
level of depressive state (efficacy outcome)
Hospital Anxiety and Depression scale (HADS)
Measured: V1 (pre-intervention visit)+ 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start14 Dec 2023
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil, SARL BOUCHARENC, Saint-Chély d'Apcher, France, Université d'Auvergne, NEURO-DOL (UMR 1107 INSERM / UCA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761015
- Sponsor's protocol ID
- RBHP 2022 DUALE
- Acronym
- PERIPATEI
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rehabilitation Walking Program With the Help of a Transient Intake of Nonsteroidal Anti-inflammatory Drug for Patients With Painful Hip/Knee Osteoarthritis - A Pilot Cohort Study With Objectives of Short Walks in the Real Life.
- ClinicalTrials.gov ID
- NCT05761015
- Acronym / sponsor ID
- PERIPATEI / RBHP 2022 DUALE
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Chronic Pain
- Keywords
- Osteoarthritis, Knee, Osteoarthritis, Hip, pain at movement, nonsteroidal anti-inflammatory drug, acetaminophen, paracetamol, personalized medicine, pharmacovigilance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation Apicil, SARL BOUCHARENC, Saint-Chély d'Apcher, France, Université d'Auvergne, NEURO-DOL (UMR 1107 INSERM / UCA)
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 9 Mar 2023 (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.
There is a lack of effective analgesic treatments to help walking patients with painful hip/knee osteoarthritis. Our team therefore imagined a new strategy lying on a multimodal rehabilitation walking program with the help of a transient intake of nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are indeed known to act specifically on pain at movement, but their continuous intake would induce unacceptable side effects. To optimize the benefit/risk balance, the molecule to be chosen must fit to the patient's profile, and its intake should cover only the period of interest, i.e. planned walks. Our multimodal rehabilitation program will also include physical techniques such as appropriate footwear, a patient's education aiming at reducing fear/avoidance and spotting side effects of NSAIDs, and a prescription frame to avoid any overdosing.
This clinical study is a single-center, non-randomized, open label, one-arm trial, using drugs prescribed according to their label (i.e. osteoarthritis pain), pending a reinforced monitoring of side effects.
The primary endpoint is to evaluate efficacy and tolerance of a tailored and transient administration of NSAID within a rehabilitation walking program in patients with painful hip/knee osteoarthritis.
Secondary endpoints are to evaluate the adherence to the program and the factors influencing adherence; to identify the less well tolerated conditions of treatment (one condition being one molecule for one patient profile); to identify the factors of success among a set of baseline demographic, morphometric and psychometric variables; and to study the role of central sensitization (assessed by temporal summation) on the efficacy of treatment.
Detailed description
Study schedule:
- Inclusion visit (V0): check of the eligibility criteria, explanation of the protocol, plan for a podiatric consultation, baseline questionnaires, and delivery of diary to collect efficacy outcomes.
- Observation time (4 weeks): baseline measurement of efficacy outcomes (physical activity and pain at walk), podiatric consultation and improvement of footwear (including orthosis or soles).
- Pre-intervention visit (V1) : collection of self-reported outcomes, measurement of temporal summation, 6-min walk test before and after NSAID test *, plan for the first 6-week intervention period and delivery of diary to collect efficacy and tolerance outcomes.
- Intermediate within-intervention visit (after 6 weeks): collection of self-reported outcomes, blood sampling (biological tolerance outcomes), plan for the second 6-week intervention period and delivery of diary to collect efficacy and tolerance outcomes.
- End-of-study visit: collection of self-reported outcomes, blood sampling (biological tolerance outcomes), and collection of last efficacy outcomes (anxiety, depression, kinesiophobia, global impression of change).
- The patient will undergo two 6-min walk tests at the pre-intervention visit, one before and one 45 min. after oral administration of the NSAID. The patient will be considered as responsive to the NSAID if one of the following criteria occurs: a 15% increase (or more) of the time-to-first pain at walk, self-defined as bothering; a 1-point decrease (or more) of pain intensity (out of 10) throughout the test; or a 15% increase (or more) of the walked distance, if this was < 200 m at the first test. Only patients responsive to the NSAID will continue the trial.
The sequence of successes will be treated in Bayesian analyses. Sequential analyses with be conducted stepwise. At each step, the decision to stop or to keep going will be taken, until a maximum of 50 cases eligible for analysis.
- 1st step (N=20): stop for efficacy if more than 11 successes; stop for non-efficacy if less than 6 successes; continuation otherwise (20 supplementary patients);
- 2nd step (N=40): stop for efficacy if more than 17 successes; stop for non-efficacy if less than 16 successes; continuation otherwise (20 supplementary patients);
- 3rd step (N=50): efficacy if more than 21 successes; non-efficacy otherwise
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: therapeutic program including intermittent drug intake and multimodal rehabilitation programthere is only one intervention arm and no control arm; the Bayesian analysis will be conducted under hypothetical estimates of superiority vs. control. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Uni- or bilateral hip or knee idiopathic osteoarthrosis (ACR criteria, Kellgren-Lawrence grade 2 or more on recent X-ray), responsible for pain since 3 at least months, and pain at walking which intensity is at least 4/10 on a numerical rating scale.
- Less than 3 relevant walks (at least 20 minutes or 1000 km) a week.
- Ability to understand and to follow the protocol, and to answer the questionnaires
Key exclusion criteria (20 listed)
- Pregnancy or breastfeeding
- Legal protection
- Body weight < 40 kg or underweight
- Body weight >120 kg or obesity
- Unability to walk, or unability to walk without support devices (sticks, crutches, orthoses and knee pads are allowed)
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 |
|---|---|---|
| therapeutic program including intermittent drug intake and multimodal rehabilitation programThe prescribed NSAID molecule shall be chosen according to the patient's risk profile: * gastric/duodenal risk: age >65, history of ulcer with remission, history of inflammatory event, current low-dose acetylsalicylic acid treatment ; * cardiovascular risk (according to Agostino scale \& SCORE); The molecule with therefore be: * no risk: niflumic acid, 250 mg per intake; * gastric/duodenal risk only: diclofenac, 50-100 mg per intake, plus lansoprazole; * cardiovascular risk only: ketoprofen, 50-100 mg per intake; * double risk: ibuprofen, 200-400 mg per intake, plus lansoprazole. For the walk test, the highest dose of diclofenac or ketoprofen will be used. Then, the patient will be free to half the dose if pain relief is achieved so. One gram of acetaminophen will be added to any NSAID intake. The number of intakes will be limited to twice a day (morning and evening) and to 10 times a week. | Drug | Intervention |
Primary outcome
Success
Time frame: V1 (pre-intervention visit) + 12 weeks
success of the therapeutic program (defined by a 30%-increase (or more) of the monthly number of target moves from the baseline observation values, with no treatment discontinuation for NSAID side effects)
13 secondary outcomes
Self-declared physical activity (efficacy outcome)
Time frame: V1 (pre-intervention visit)
Self-declared physical activity (efficacy outcome)
Time frame: V1 (pre-intervention visit) + 6 weeks
Self-declared physical activity (efficacy outcome)
Time frame: V1 (pre-intervention visit) + 12 weeks
Actual physical activity (efficacy outcome)
Time frame: V1 (pre-intervention visit)
Actual physical activity (efficacy outcome)
Time frame: V1 (pre-intervention visit)+ 6 weeks
Actual physical activity (efficacy outcome)
Time frame: V1 (pre-intervention visit) + 12 weeks
Pain at walk during the two last weeks (efficacy outcome)
Time frame: V1 (pre-intervention visit)
Pain at walk during the two last weeks (efficacy outcome)
Time frame: V1 (pre-intervention visit) + 6 weeks
Pain at walk during the two last weeks (efficacy outcome)
Time frame: V1 (pre-intervention visit)+ 12 weeks
Patient's Global Impression of Change (efficacy outcome)
Time frame: V1 (pre-intervention visit) + 12 weeks
kinesiophobia (efficacy outcome)
Time frame: V1 (pre-intervention visit) + 12 weeks
level of anxious state (efficacy outcome)
Time frame: V1 (pre-intervention visit) + 12 weeks
level of depressive state (efficacy outcome)
Time frame: V1 (pre-intervention visit)+ 12 weeks
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing therapeutic program including intermittent drug intake and multimodal rehabilitation program in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: V1 (pre-intervention visit) + 12 weeks). 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 27 Feb 2026.