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Clinical Trials/CTRI/2025/01/078905
CTRI/2025/01/078905RecruitingPhase 3

Evaluate the effect of cold knee pack on pain pressure threshold and range of motion in knee osteoarthritis

Dr Narmatha M1 site in 1 country60 target enrollmentStarted: February 1, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Pain Pressure Threshold (PPT) will be measured by using an Algometer at the medial aspect of the patient’s affected knee

Study Overview

Brief Summary

Osteoarthritis (OA) is a chronic, progressive joint disorder characterized by cartilage degeneration, pain, stiffness, and functional limitations, predominantly affecting weight-bearing joints such as the knees. It is influenced by factors like aging, obesity, joint trauma, and repetitive use, with knee OA being particularly prevalent among the elderly and women. Cold therapy, especially cold knee packs, offers a non-invasive treatment option with physiological effects, including reduced nerve conductivity, inflammation, and pain, as well as improved pain thresholds and joint mobility. However, despite its widespread use, there is limited scientific evidence quantifying its benefits. This study aims to address this gap through a randomized controlled trial involving 60 participants aged 40–75 years with knee OA. The study group will receive yoga and naturopathy interventions combined with a cold knee pack, while the control group will receive only yoga and naturopathy. Pain Pressure Threshold (PPT), assessed with a Biotronix Digital Pressure Algometer, will serve as the primary outcome, while pain intensity and Range of Motion (ROM), evaluated using the Visual Analogue Scale (VAS) and a goniometer, respectively, will be secondary outcomes. Statistical analysis will determine the efficacy of cold knee packs in improving PPT, pain, and ROM in individuals with knee OA.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Experiencing mild to moderate knee pain.
  • Able to provide informed consent.

Exclusion Criteria

  • Recent knee surgery within six months, Use of other treatments for knee osteoarthritis during the study period, Conditions contraindicating cold therapy, Presence of open wounds, skin infections, or dermatological conditions on the knee, Neurological disorders affecting sensory perception, Rheumatoid arthritis and Gouty arthritis.

Outcomes

Primary Outcomes

Pain Pressure Threshold (PPT) will be measured by using an Algometer at the medial aspect of the patient’s affected knee

Time Frame: baseline and after three weeks

Secondary Outcomes

  • Pain and Range of Motion (ROM) in knee osteoarthritis using a Visual analogue scale (VAS), and Goniometer before and after the intervention(Baseline and after three weeks)

Investigators

Sponsor
Dr Narmatha M
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Narmatha M

International Institute of Yoga and Naturopathy Medical Sciences

Study Sites (1)

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