Thermal Micro-cautery for Painful Knee Osteoarthritis

NCT03460717 | Completed

• 1 other identifier: 2016-10 Chairman's Action (3)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in activity levels

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

• Change in sleep pattern

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

• Change in medication use

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

Study Arms (2)

Intervention group: PNFS-TMC

EXPERIMENTAL

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.

Other: Peripheral Nerve Field Stimulation by Thermal Micro-Cautery

Control group: Stepladder analgesics

NO INTERVENTION

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.

Interventions

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.

Intervention group: PNFS-TMC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• awaiting knee replacement surgery on an orthopaedic waiting list

You may not qualify if:

• none

Sponsors & Collaborators

• The National Children's Hospital, Tallaght: lead

Study Sites (1)

Tallaght University Hospital

Dublin, D24NROA, Ireland

Location

Study Officials

• camillus power, MD

  Tallaght University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the person performing the intervention and the assessment are different
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pain Medicine

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

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 9, 2018
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: November 7, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)