None listed
Conditions
Brief summary
This study aims to assess the efficacy of use of two different Niagara Thermo Cyclo Pad units, used twice daily for 20 minutes for four weeks on knee pain, stiffness and symptoms in knee osteoarthritis patients, using a randomised, placebo–controlled double–blind design over four weeks.
Interventions
This study will test the use of two different Niagara Thermo Cyclo Pad units (the Niagara Thermo Cyclo Pad unit, and the Niagara Thermo Cyclo Pad hand held unit) against a sham/control unit, used twice daily for 20 minutes for 4 weeks. The units will be used on the ‘study/target knee’ throughout the entire 4 week period, which is the most painful, eligible knee at screening.
The two intervention units include:
1) Use of Niagara Thermo Cyclo Pad unit on heat and vibrate setting (heat is set to
This study will test the use of two different Niagara Thermo Cyclo Pad units (the Niagara Thermo Cyclo Pad unit, and the Niagara Thermo Cyclo Pad hand held unit) against a sham/control unit, used twice daily for 20 minutes for 4 weeks. The units will be used on the ‘study/target knee’ throughout the entire 4 week period, which is the most painful, eligible knee at screening. The two intervention units include: 1) Use of Niagara Thermo Cyclo Pad unit on heat and vibrate setting (heat is set to 8 degrees above the ambient temperature, vibrate setting 3 (32-35 Hz)). 2) Use of Niagara Thermo Cyclo Pad on heat and vibrate setting (as above), combined with the use of the Niagara Thermo Cyclo Pad hand held unit on vibrate setting (35 Hz). Use of the Niagara Thermo Cyclo Pad involves placing the Cyclo Pad on your seat/chair/couch with the pad placed under the hamstring and the round motor end positioned directly and firmly under the study knee. The vibrate setting will be set to level 3 (32-35 Hz) and the heat setting is set to 8 degrees above the ambient temperature, therefore it will change based on the temperature of the room it is used in. Use of the Niagara Thermo Cyclo Pad hand held unit involves placing the hand unit lengthways on the top of the thigh/quadriceps with the black Rubber cup attachment pressing against the top of the knee (where the knee is most painful) and holding it in place until the treatment has finished. The vibrate setting will be set to 35 Hz. The units vibrate and heat settings will be programmed into the units by CT Healthcare so that they will not able to be altered by the participants and the participants and study staff remain blinded. Participants will be trained in the use of the devices by a study nurse who will be trained by CT Healthcare in the operation of the units. The training session with participants will be approximately 10 minutes, or until the study nurse is satisfied the participant knows how to operate the unit/units. Adherence will be measured using a daily diary where participants will be required to record how much they used the device.
Sponsors
Prof Graeme Jones
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Significant knee pain (>=40/100 on 100mm VAS) for at least 6 months. 2. Age 50 years or over. 3. Clinical knee osteoarthritis as confirmed by the ACR criteria.
Exclusion criteria
1. Severe knee OA (joint space narrowing on x-ray of Grade 3 using the OARSI atlas. 2. Forms of arthritis other than osteoarthritis. 3. Significant knee injury within last 6 months. 4. Abnormal sensation to heat, cold or vibration. 5. Use of any investigational drug(s) and/or devices within 30 days prior to randomisation. 6. The participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. 7. Unable or unwilling to comply with the requirements of this study protocol, including use of the Thermo Cyclopad units. 8. Unable or unwilling to provide written informed consent.
Outcome results
None listed