Knee OsteoarthritisNancythermalNCT01544647
Spa Therapy in Knee Osteoarthritis (OA): Nancy-thermal
A study testing Usual spa protocol and Active spa protocol in people with Knee Osteoarthritis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Usual spa protocol and Active spa protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both gender
- uni or bilateral symptomatic knee OA
- pain VAS > 3 on a 0-10 scale)
- fulfilling ACR criteria for knee OA
- Kellgren and Lawrence stage 2 or over on standard radiograph
- Non inclusion criteria are:
Show all 16Show fewer
- severe comorbidity
- isolated femoro-patellar knee OA
- total knee replacement surgery expected during the next year
- other joint disease
- a contraindication or intolerance to any aspect of spa treatment (immune deficiency, evolving cardiovascular conditions, cancer, infection),
- spa treatment within the previous 12 months
- knee injection within the past month for corticosteroids and within the past 3 months for hyaluronic acids
- osteoarthritis (SYSADOA) change in the past 3 months
- massages, physiotherapy or acupuncture in the past month
- Patients will not be allowed to modify their non-steroidal antiinflammatory drug (NSAID) or their analgesic drug within the past 5 days and in the previous 12 h respectively.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial
Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another.
The main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement at 6 months, defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis.
Read more
The secondary objectives are:
- To compare the efficacy of the 2 protocols at 3 months.
- To determine the evolution of quality of life and medical care consumption
- To describe postural abnormalities
- To determine predictive factors to a favourable response at 3 and 6 months
Read the detailed description
This is a monocentric randomised non inferiority trial comparing 2 spa therapy protocols in symptomatic knee OA.
In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. In the second group, the same 4 treatments are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.
Data will be collected at inclusion, 3 and 6 weeks and 3 and 6 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- Usual spa protocol, Active spa protocol
- Keywords
- Knee osteoarthritis, spa therapy, spa modalities
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual spa protocolOther
In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.
Active spa protocolOther
4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.
| Study group | Role | What they receive |
|---|---|---|
| Usual spa protocol | Active comparator | 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. Receives: Other: Usual spa protocol |
| Active spa protocol | Active comparator | 4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week. Receives: Other: Active spa protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery
The main outcome endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery.
Measured: 6 months
Secondary outcomes (5)
Achievement of the patient acceptable symptom state
Measured: 3 and 6 months
evolution of quality of life scores
Measured: 3 and 6 months
medical care consumption
particularly NSAIDs, pain killers
Measured: 3 and 6 months
postural abnormalities
The method used aimed at evaluating two modalities of postural regulation - quiet stance and during movement - and their related neurosensory organization. Postural control during quiet stance will be evaluated with and without sensory conflict by a static posturographic test and by a sensory organization test; postural control during movement will be evaluated by a dynamic posturographic test with slow sinusoidal oscillations.
Measured: 3 and 6 months
adverse events
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544647
- Sponsor's protocol ID
- 2011-A01319-32
- Acronym
- Nancythermal
- Status last verified
- Aug 2014
- First submitted
- 16 Feb 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial
- ClinicalTrials.gov ID
- NCT01544647
- Acronym / sponsor ID
- Nancythermal / 2011-A01319-32
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, spa therapy, spa modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Mar 2012 (estimated)
- 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.
Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another.
The main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement at 6 months, defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis.
The secondary objectives are:
- To compare the efficacy of the 2 protocols at 3 months.
- To determine the evolution of quality of life and medical care consumption
- To describe postural abnormalities
- To determine predictive factors to a favourable response at 3 and 6 months
Detailed description
This is a monocentric randomised non inferiority trial comparing 2 spa therapy protocols in symptomatic knee OA.
In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. In the second group, the same 4 treatments are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.
Data will be collected at inclusion, 3 and 6 weeks and 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual spa protocol | Active comparator | Other: Usual spa protocol4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. |
| Active spa protocol | Active comparator | Other: Active spa protocol4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- both gender
- uni or bilateral symptomatic knee OA
- pain VAS > 3 on a 0-10 scale)
- fulfilling ACR criteria for knee OA
- Kellgren and Lawrence stage 2 or over on standard radiograph
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Usual spa protocolIn the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. | Other | Usual spa protocol |
| Active spa protocol4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week. | Other | Active spa protocol |
Primary outcome
Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery
Time frame: 6 months
The main outcome endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery.
5 secondary outcomes
Achievement of the patient acceptable symptom state
Time frame: 3 and 6 months
evolution of quality of life scores
Time frame: 3 and 6 months
medical care consumption
Time frame: 3 and 6 months
postural abnormalities
Time frame: 3 and 6 months
adverse events
Time frame: 3 and 6 months
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 15 Aug 2014.
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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.
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 Usual spa protocol and Active spa protocol in people with Knee Osteoarthritis, run by Central Hospital, Nancy, France 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 16 inclusion and 0 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 15 Aug 2014. 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.
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?
Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery (time frame: 6 months). 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 15 Aug 2014.