Thermal Micro-cautery for Painful Knee Osteoarthritis

Chronic Pain Syndrome Clinical Trial

— TMC-PKO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460717
• Other study ID #: 2016-10 Chairman's Action (3)
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: March 2018
• Source: The National Children's Hospital, Tallaght
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• awaiting knee replacement surgery on an orthopaedic waiting list

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Peripheral 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.

Locations

Country	Name	City	State
Ireland	Tallaght University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
The National Children's Hospital, Tallaght

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAS score reduction after 4 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.	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	Change in activity levels	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	The objective activity score was recorded every two weeks after each session with a total of 4 sessions over 8 weeks
Secondary	Change in sleep pattern	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	The change in the sleep pattern was recorded every two weeks after each session with a total of 4 sessions over 8 weeks
Secondary	Change in medication use	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	The change in the medication use was recorded every two weeks after each session with a total of 4 sessions over 8 weeks