Chronic Pain SyndromeTMC-PKONCT03460717
Thermal Micro-cautery for Painful Knee Osteoarthritis
A study testing Peripheral Nerve Field Stimulation by Thermal Micro-Cautery in people with Chronic Pain Syndrome, run by The National Children's Hospital, Tallaght at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- Peripheral Nerve Field Stimulation by Thermal Micro-Cautery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 1 Nov 2016to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- awaiting knee replacement surgery on an orthopaedic waiting list
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Nerve Field Stimulation by Thermal Micro-cautery for Painful Knee Osteoarthritis: Non Randomised Controlled Trial
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.
Read the 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
- Being tested
- Peripheral Nerve Field Stimulation by Thermal Micro-Cautery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve Field Stimulation by Thermal Micro-CauteryOther
The most painful points over the knee received an intense heat by a metal rod for 0.5 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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
Measured: 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 subjective scores reported by patient as follows, score 1 means improved, 2 means worse and 3 means the same as before
Measured: 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
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
Measured: The change in the medication use was recorded every two weeks after each session with a total of 4 sessions over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Nov 2016
- Primary completion1 Jul 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- intervention offered and those who decline are followed as a waiting list control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Children's Hospital, Tallaght
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camillus Power, The National Children's Hospital, Tallaght
- Investigators
- camillus power, MD, Principal investigator, Tallaght University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460717
- Sponsor's protocol ID
- 2016-10 Chairman's Action (3)
- Acronym
- TMC-PKO
- Status last verified
- Mar 2018
- First submitted
- 9 Feb 2018
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Field Stimulation by Thermal Micro-cautery for Painful Knee Osteoarthritis: Non Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03460717
- Acronym / sponsor ID
- TMC-PKO / 2016-10 Chairman's Action (3)
- Conditions
- Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The National Children's Hospital, TallaghtUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention offered and those who decline are followed as a waiting list control
| Arm | Type | Receives |
|---|---|---|
| Intervention group: PNFS-TMC | Experimental | Other: Peripheral Nerve Field Stimulation by Thermal Micro-CauteryProcedure- 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- awaiting knee replacement surgery on an orthopaedic waiting list
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Nerve Field Stimulation by Thermal Micro-CauteryThe most painful points over the knee received an intense heat by a metal rod for 0.5 seconds. | Other | Intervention group: PNFS-TMC |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
camillus power, MD principal investigator
Tallaght University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Nerve Field Stimulation by Thermal Micro-Cautery in people with Chronic Pain Syndrome, run by The National Children's Hospital, Tallaght at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.