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Thermal Micro-cautery for Painful Knee Osteoarthritis

Peripheral Nerve Field Stimulation by Thermal Micro-cautery for Painful Knee Osteoarthritis: Non Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03460717
Acronym
TMC-PKO
Enrollment
30
Registered
2018-03-09
Start date
2016-11-01
Completion date
2018-09-01
Last updated
2019-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain Syndrome

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.

Interventions

OTHERPeripheral Nerve Field Stimulation by Thermal Micro-Cautery

The most painful points over the knee received an intense heat by a metal rod for 0.5 seconds.

Sponsors

The National Children's Hospital, Tallaght
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

the person performing the intervention and the assessment are different

Intervention model description

intervention offered and those who decline are followed as a waiting list control

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* awaiting knee replacement surgery on an orthopaedic waiting list

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Change in VAS score reduction after 4 sessionsVAS score was recorded every two weeks, after each session with a total of 4 sessions over 8 weeks. 2 weeks interval between sessionsTo measure the change in a visual analogue scale is a numerical ruler of 10 cm in length with each centimetre marked and the patient chooses a number between one and ten to score their pain where zero is no pain and 10 is the worst pain that the subject can imagine.

Secondary

MeasureTime frameDescription
Change in activity levelsThe objective activity score was recorded every two weeks after each session with a total of 4 sessions over 8 weeksThe change in the activity subjective scores reported by the patient as follow; score 1 means improved , score 2 means worse and score 3 means no change
Change in sleep patternThe change in the sleep pattern was recorded every two weeks after each session with a total of 4 sessions over 8 weeksThe change in the subjective scores reported by patient as follows, score 1 means improved, 2 means worse and 3 means the same as before
Change in medication useThe change in the medication use was recorded every two weeks after each session with a total of 4 sessions over 8 weeks1 means improved as in less use of medication, 2 means worse more use of medication and 3 means the same use of analgesic medication

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026