Clinical trial NCT03460717: Thermal Micro-cautery for Painful Knee Osteoarthritis
Official title: Peripheral Nerve Field Stimulation by Thermal Micro-cautery for Painful Knee Osteoarthritis: Non Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain Syndrome
Lead sponsor: The National Children's Hospital, Tallaght
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: intervention offered and those who decline are followed as a waiting list control
Primary purpose: TREATMENT

Brief summary: To trial a traditional pain management technique from Ayurveda in a modern way - the technique involves micro - cautery to painful areas in knee osteoarthritis for patients on a waiting list for knee replacement. The Investigators will include a waiting list control series.

Detailed description: The Research and Ethics Committee at Tallaght University Hospital approved the recruitment of patient into the study by invitation. Patients who accepted the invitation were enrolled into the intervention group and patients who declined the invitation were enrolled into the control group and both groups were followed up for 8 week period. Agnikarma is a traditional surgical technique (thermal cautery) described in ancient surgical manuscripts for the treatment of severe persistent pain.

It applies intense heat to points of maximum pain agreed with the patient pre procedure. The heat is applied by a metal rod (Shalaka) heated in an open naked flame. The rod is applied to the skin at the agreed pain point in an even manner and generates a micro second degree burn. A traditional herbal cream is then applied which cools the application as reported by the patient. It is usual to allow skin healing to occur before the application of further heat (1-2 weeks). The pain points can move within a painful area and the technique best works with precise application to the current pain point. So before each application the precise points are agreed with the patient in advance by demarcating the painful area with a pen and searching for the points of maximum tenderness within that field.

The purpose of this study was simply to define if indeed this technique delivers pain relief as observed in practice. The investigators chose one group to study - painful knee arthritis. In this condition patients often wait many years for the definitive procedure and run some risks with current pain relief treatment. As these patients were not the normal attendees at a pain clinic the investigators decided in advance to limit the study to 4 applications over a 4- 8 week period, the latter to allow for different speeds at which the skin might heal. The investigators recruited both our interventional group and waiting list control group from the same orthopedic waiting list.

Eligibility criteria: Inclusion Criteria:

* awaiting knee replacement surgery on an orthopaedic waiting list

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in VAS score reduction after 4 sessions
timeFrame: VAS score was recorded every two weeks, after each session with a total of 4 sessions over 8 weeks. 2 weeks interval between sessions
Secondary outcomes:
measure: Change in activity levels
timeFrame: The objective activity score was recorded every two weeks after each session with a total of 4 sessions over 8 weeks
measure: Change in sleep pattern
timeFrame: The change in the sleep pattern was recorded every two weeks after each session with a total of 4 sessions over 8 weeks
measure: Change in medication use
timeFrame: The change in the medication use was recorded every two weeks after each session with a total of 4 sessions over 8 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Tallaght University Hospital
Study officials:
affiliation: Tallaght University Hospital
name: camillus power, MD
role: PRINCIPAL_INVESTIGATOR
References: