Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.

NCT05677399 | Completed DMC

• 1 other identifier: 5000007
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim was to observe the short and medium term effects of peloidotherapy and aquatic exercise applications in patients with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; peloidotherapy; aquatic exercise; water based exercise; balneotherapy; aquatic rehabilitation

Outcome Measures

Primary Outcomes (2)

• Pain (VAS)

  The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.

  Change from baseline pain (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.

• WOMAC (total)

  The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC

  Change from baseline WOMAC scores at the end of the treatment, 1 month after treatment ,3 months after treatment.

Secondary Outcomes (9)

• IGA (VAS)

  Change from baseline IGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.

• PGA (VAS)

  Change from baseline PGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.

• WOMAC (pain)

  Change from baseline WOMAC (pain) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.

• WOMAC (stiffness)

  Change from baseline WOMAC (stiffness) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.

• WOMAC (physical function)

  Change from baseline WOMAC (physical function) at the end of the treatment, 1 month after treatment ,3 months after treatment.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Treatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions).

Other: aquatic exercise and peloidotherapy

Control Group

NO INTERVENTION

Control group continued to use their usual medical treatment.

Interventions

aquatic exercise and peloidotherapy OTHER

Treatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions).

Also known as: water based exercise and mud pack therapy

Treatment Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis diagnosed according to the ACR criteria
• gave their written informed consent
• ages
• Kellgren Lawrence grading 2-4
• having symptomatic knee pain at least 3 months.

You may not qualify if:

• secondary knee OA
• pathology of the waist, hip, or ankle joints
• decompensated organ failure
• malignancy,
• active bleeding
• infectious disease
• serious knee injuries or previous surgical procedures within the past 6 months
• the use of intraarticular steroids and hyaluronic acid injection to the knee joint within the past 6 months
• physiotherapy, balneotherapy, or peloidotherapy within the past 1 year.

Sponsors & Collaborators

• Istanbul Arel University: lead

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: OUTCOMES ASSESSOR
• Masking Details: Patients were assessed before treatment, after treatment, 1 month after treatment and 3 month after treatment by the investigator (İ.T.) who was blinded to the study. İ.T. is medical doctor who didn't know the patients' groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: A Randomized, single blind, prospective, parallel 1:1 group study.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 10, 2023
• Study Start: September 9, 2015
• Primary Completion: June 10, 2016
• Study Completion: December 10, 2016
• Last Updated: January 10, 2023

Record last verified: 2023-01