NCT00726492

Brief Summary

Osteoarthritis, a common disorder increasing in prevalence with advancing age, is particularly debilitating when the knees are affected. This study examined the value of hydrotherapy (exercise in water) and continuous short-wave diathermy (an electrical deep heat treatment) for the relief of osteoarthritic symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2001

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

1.8 years

First QC Date

July 29, 2008

Last Update Submit

July 29, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Six-minute walk test

    4 and 8 weeks

Secondary Outcomes (4)

  • Visual analogue pain scale (10 cm line)

    4 and 8 weeks

  • Knee range of motion

    4 and 8 weeks

  • Arthritis Impact Measurement Scale 2 (AIMS 2)

    4 and 8 weeks

  • Patient interview

    4 and 8 weeks

Study Arms (4)

CSWD + Hydro

EXPERIMENTAL

Continuous short wave diathermy and hydrotherapy

Other: Continuous short wave diathermy (CSWD)Other: Hydrotherapy

Hydro alone

EXPERIMENTAL

Hydrotherapy alone

Other: Hydrotherapy

CSWD alone

EXPERIMENTAL

Continuous short wave diathermy alone

Other: Continuous short wave diathermy (CSWD)

Control

NO INTERVENTION

No treatment

Interventions

CSWD applied twice a week for 4 weeks

CSWD + HydroCSWD alone

Hydrotherapy (exercise in water) attended twice a week for 4 weeks

CSWD + HydroHydro alone

Eligibility Criteria

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

You may qualify if:

  • Patients had to have a documented diagnosis of osteoarthritis of their knees.
  • Patients had to be between 50 and 70 years inclusive.
  • Patients had to have X-ray evidence of osteoarthritis of their knees.

You may not qualify if:

  • Patients with another rheumatological condition other than osteoarthritis.
  • Patients who were unable to understand the concepts, assessment and treatment involved.
  • Patients who had received a cortisone injection into the knee in the previous 30 days.
  • Patients for whom CSWD or hydrotherapy has been contraindicated.
  • Patients who have had either CSWD or hydrotherapy in the past.
  • Patients who had undergone a surgical procedure on either lower limb in the past 6 months.
  • Patients who were receiving other physiotherapy treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mater Misericodriae University Hospital

Dublin, Dublin, 7, Ireland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Tara Cusack, MMedSc PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR
  • Conor J McCarthy, MD

    Mater Misericordiae University Hospital

    PRINCIPAL INVESTIGATOR
  • Leslie Daly, BSc MSc PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR
  • Mary F McAteer, MEd PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2008

First Posted

August 1, 2008

Study Start

June 1, 2001

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations