NCT01942317

Brief Summary

The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

1.4 years

First QC Date

September 10, 2013

Last Update Submit

September 10, 2013

Conditions

Knee Osteoarthritis, Obesity

Outcome Measures

Primary Outcomes (1)

  • Knee pain measurement with Visual Analogue Scale (VAS)

    At the begining and at the end of the treatment. After 6 months of the end of therapy

Secondary Outcomes (1)

  • Knee range of motion

    At the begining and at the end of the treatment. After 6 months of the end of therapy

Study Arms (2)

Balneotherapy

EXPERIMENTAL

16 balneotherapy treatments, each of 45 minutes, twice a week, for 8 consecutive weeks

Other: Balneotherapy

Physiotherapy

NO INTERVENTION

16 physiotherapy treatments (no balneotherapy), each of 45 minutes, twice a week, for 8 consecutive weeks

Interventions

BalneotherapyOTHER
Balneotherapy

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obesity II-III grade (BMI 35-45 kg/m2)
  • knee pain
  • patient compliance to the treatment

You may not qualify if:

  • BMI\<34,9kg/m2 or BMI\> 45,1kg/m2
  • previous knee surgery
  • complicated diabetes mellitus
  • ischemic cardiomyopathy and heart failure
  • acute phase of osteoarthritis
  • varicose veins, deep venous thrombosis (DVT)
  • cancer
  • cutaneous lesions
  • NSAIDs administration \<1 week before the treatment
  • knee infiltration \<2 months before the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera-Università degli studi di Padova

Padua, Italy, 35128, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, KneeObesity

Interventions

Balneology

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professore Ordinario

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations

IT(1)