Spa Therapy in Knee Osteoarthritis (OA): Nancy-thermal

NCT01544647 | Completed DMC

• 1 other identifier: 2011-A01319-32
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.To compare the efficacy of the 2 protocols at 3 months.
2. 2.To determine the evolution of quality of life and medical care consumption
3. 3.To describe postural abnormalities
4. 4.To determine predictive factors to a favourable response at 3 and 6 months

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; spa therapy; spa modalities

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Achievement of the patient acceptable symptom state

  3 and 6 months

• evolution of quality of life scores

  3 and 6 months

• medical care consumption

  3 and 6 months

• postural abnormalities

  3 and 6 months

• adverse events

  3 and 6 months

Study Arms (2)

Usual spa protocol

ACTIVE COMPARATOR

4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.

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.

Other: Active spa protocol

Interventions

Usual spa protocol OTHER

In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.

Usual spa protocol

Active spa protocol OTHER

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.

Active spa protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nancy university hospital center

Nancy, 54000, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 6, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

FR (1)