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Completed

NCT Number: NCT03460717

Thermal Micro-cautery for Painful Knee Osteoarthritis

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.

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Key information

Conditions

Chronic Pain Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallaght University Hospital

Dublin, D24NROA, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • awaiting knee replacement surgery on an orthopaedic waiting list

Exclusion criteria

  • none

Treatment and study plan

Peripheral Nerve Field Stimulation by Thermal Micro-Cautery

Other

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

Primary outcomes

  1. Change in VAS score reduction after 4 sessions

    Time frame: VAS score was recorded every two weeks, after each session with a total of 4 sessions over 8 weeks. 2 weeks interval between sessions

    To 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 outcomes

  1. Change in activity levels

    Time frame: The objective activity score was recorded every two weeks after each session with a total of 4 sessions over 8 weeks

    The 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

  2. Change in sleep pattern

    Time frame: The change in the sleep pattern was recorded every two weeks after each session with a total of 4 sessions over 8 weeks

    The change in the subjective scores reported by patient as follows, score 1 means improved, 2 means worse and 3 means the same as before

  3. Change in medication use

    Time frame: The change in the medication use was recorded every two weeks after each session with a total of 4 sessions over 8 weeks

    1 means improved as in less use of medication, 2 means worse more use of medication and 3 means the same use of analgesic medication

Sponsors and collaborators

Lead sponsor

The National Children's Hospital, Tallaght

Other

Registry information

Official study title

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

Acronym: TMC-PKO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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