Thermal Micro-cautery for Painful Knee Osteoarthritis

NCT ID: NCT03460717

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2018-09-01

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.

Conditions

Chronic Pain Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group: PNFS-TMC

Procedure- The patients in the intervention group were examined and the most painful points over the knee with the avoidance of the proposed site for skin incision for a future knee replacement operation were marked. The marked points received an intervention in the form of application of Peripheral Nerve Field Stimulation by Thermal Micro-Cautery (PNFS-TMC), an intense heat by metal rod was applied to the painful points for 0.3 to 0.5 seconds. The patients to receive 4 sessions over a period of 8 weeks with 2 weeks rest after every session.

Group Type: EXPERIMENTAL

Peripheral Nerve Field Stimulation by Thermal Micro-Cautery

Intervention Type: OTHER

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

Control group: Stepladder analgesics

Patients with painful knee osteoarthritis and on the waiting list for a total knee replacement surgery and declined to have PNFS-TMC were included in the control group. The control group received the stepladder analgesic protocol for pain management. The analgesic protocol was managed by the orthopaedic team without any interference by the investigators.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• awaiting knee replacement surgery on an orthopaedic waiting list

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The National Children's Hospital, Tallaght

OTHER

Sponsor Role: lead

Responsible Party

Camillus Power

Director of Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

camillus power, MD

Role: PRINCIPAL_INVESTIGATOR

Tallaght University Hospital

Locations

Tallaght University Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

2016-10 Chairman's Action (3)

Identifier Type: -

Identifier Source: org_study_id