Inflammatory Bowel DiseaseET&CPNCT05394272
Efficacy of Energy Therapy in the Management of Chronic Pain Medical Condition in Children and Adolescents.
A study testing Energy Therapy - Pranic Healing in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Paediatric and adolescent patients with chronic pain associated with their medical condition will be invited to participate in this study. Most patients for this study will be recruited from gastroenterology and hepatology clinics at KCH. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Energy Therapy - Pranic Healing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2022to 16 Jun 2025
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Registered patients at King's College Hospital Male and Female 5-18 years old Symptoms of chronic pain associated with medical condition
Who cannot join
- Under 5 years of age and older than 18 years No symptoms of pain
Trial locations and contacts
1 site in 1 country.
Benjamin Hope, MBBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Anju Bhatia, BDS, 0203 2992495, anju.bhatia@nhs.net
Ben Hope, MBBS, benhope@nhs.net
About this study
Official title: Efficacy of Energy Therapy in the Management of Chronic Pain and Associated Medical Condition in Children and Adolescents.
Paediatric and adolescent patients with chronic pain associated with their medical condition will be invited to participate in this study. Most patients for this study will be recruited from gastroenterology and hepatology clinics at KCH. Therefore the rationale for the study is primarily with consideration of each of these medical conditions all with the common symptom of chronic pain. Inflammatory bowel disease disorders(IBD), such as Crohn's Disease and Ulcerative Colitis, disorders of gut-brain interaction (DGBI) all experience chronic pain. however children with DGBI do not have an underlying specific lesion causing the pain. The chronic pain is the disease. In addition to this Chronic pancreatitis in children and adolescents can cause severe pain.
All of these groups of patients suffer with chronic pain and this can result in failure to thrive and have a negative impact on quality of life.
Read more
There is a need for further development of a non - pharmacological approach to support these patients with their symptoms of pain and in turn improve quality of life.
This study is designed to evaluate the benefits of a complementary natural therapy for paediatric and adolescent patients registered at King's College Hospital, with a diagnosis of a disease or disorder with associated symptoms of chronic pain. The age group is 5-18 years old.
The therapy to be evaluated is an energy therapy (Pranic Healing). This therapy is non -invasive, non- touch, non- pharmacological and natural. The study will assess the benefits these patients experience with their symptoms of pain after 8 weeks of weekly energy therapy sessions each session is 30 minutes and 3 visits each 4 weeks apart.
Qualitative and Quantitative data will be collected and evaluated.
Read the detailed description
Primary Objective:
The primary objective of this study is to evaluate how effective a complementary therapy, Energy Therapy (Pranic Healing) is for children and adolescents that experience chronic pain.
Secondary Objective:
To evaluate efficacy of this energy therapy in reduction in clinical symptoms/pathology associated with the child's / adolescent's medical condition causing the chronic pain.
Longitudinal, experimental qualitative and quantitative research project. Non-pharmacological, non- invasive, natural complementary therapy.
The study is a controlled trial without randomisation experimental, longitudinal study designed to evaluate the efficacy of a non - pharmacological complementary therapies for children and adolescents with chronic.All participants are patients at King' College Hospital.
Recruitment
The initial recruitment for the study will be for patients from Gastroenterology and hepatology clinics at King's College Hospital. Patients with chronic pain with other medical conditions will be recruited as study progresses.
All families will be contacted by the medical care team or via the patient database by post/email with the PIL/PIS and ET information booklet (age appropriate).
Families will be contacted via email/ telephone, those interested in participation will be invited to an informal information session virtually or face to face.
The PIS will be discussed, any concerns regarding the study will be clarified. Parents will be asked to give informed consent if they would like their child to participate.
All participants will continue with their routine medical care and treatment at King's College Hospital.
Baseline Characteristics
To be collected prior to the intervention.
Pain -Visual Analogue Scale P-VAS - to be completed for 10 days prior to first session and daily for the duration of the study
Paediatric Ulcerative Colitis Activity Index (PUCAI) questionnaire- to be completed prior to the first session, subsequently every 4 weeks for the duration of the study for those patients with Ulcerative Colitis.
Paediatric Crohn's Disease Activity Index (PCDAI) questionnaire -to be completed prior to the first session subsequently every 4 weeks for the duration of the study for those patients with Crohn's Disease.
Faecal Calprotectin (FCP) - IBD PATIENTS will give a stool sample for a FCP test prior to their first session. Parents may bring the sample with them on the first appointment.
FCP samples will then be collected every 4 weeks for the duration of the study for patients with IBD.
Amylase (Blood test /Urine sample) BT/US Baseline level from last sample - patient records, collect sample at 4 weeks 8 weeks and 20 weeks (CP patients and pts where blood test routinely collected to evaluate clinical /physical symptoms).
Height and Weight (H\&W) will be recorded at the first visit and every 4 weeks for the duration of the study for all patients.
Medication - a table recording medication dosage and frequency for abdominal pain will be requested to be completed for 10 days prior to the first session and every day throughout the study.
Journal - A diary will be given to patients /parents for young children,10 days prior to the study and for completion logging any changes through the study with pain associated with
Inflammatory Bowel Disease ( Ulcerative Colitis and Crohn's Disease) and Disorders of Gut- Brain Interaction and Chronic Pancreatitis and other medical conditions with manifestations of chronic pain 100
- Recruitment process via referral from medical care team and patient database (registered paediatric and adolescent patients with chronic pain linked with medical condition at KCH)
- Post/email PIS/PIL age appropriate information booklet
- Informal information session / patient screening
- Parent /adolescent giving consent if wishing to participate
- Letter to GP informing of participation in study.
- Letter to school /employer with dates and times of appointments where appropriate and requested.
- 10 days prior to first session P-VAS completed daily Medication table for pain daily Journal
- First appointment for Energy Therapy- prior to session PUCAI or PCDAI for IBD participants. Collection of FCP/BT/ US sample, if baseline not available in patient records. H\&W.
- Daily completion of P-VAS/medication for pain and journal
- Weekly visits for 8 weeks - 30 minutes each visit
- 4 weeks stage PUCAI/PCDAI/FCP/BT/US/H\&W to be collected.
- 8 week stage PUCAI/PCDAI/ H\&W /FCP/BT/US to be collected.
- Energy Therapy sessions to be every 4 weeks for 3 months. For the 3 visits PUCAI/PCDAI/H\&W/FCP/BT/US For the final visit BT/US collection in addition.
22 weeks
Inclusion Criteria:
Registered Paediatric patient at King's College Hospital 5-18years of age Male and Female Diagnosis of medical condition with associated chronic pain Symptoms of Pain
Exclusion Criteria
Under 5 years old and older than 18 years old
No symptoms of pain
- Being tested
- Energy Therapy - Pranic Healing
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Therapy - Pranic HealingOther
Energy therapy - Non invasive non touch and non pharmacological - 100% natural complementary therapy
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of Energy Therapy - Pranic Healing with chronic pain | Experimental | Energy therapy - Pranic Healing to be applied for 8 weeks weekly and 3 times 4 weeks apart for relief of chronic pain Receives: Other: Energy Therapy - Pranic Healing |
| Efficacy of Energy Therapy - Pranic Healing - with linked medical condition | Experimental | Energy Therapy - Pranic Healing protocol for linked medical condition applied for 8 weeks weekly and 3 times 4 weeks apart , relevant BT/Urine sample /stool sample 4 weeks apart to evaluate changes. Receives: Other: Energy Therapy - Pranic Healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
P-VAS validated questionnaire
reduction in symptoms of chronic pain with Energy therapy
Measured: 20 weeks
Secondary outcomes (1)
stool samples/urine samples and blood tests
stool samples - faecal calprotectin
Faecal calprotectin
Measured: Patient will have 8 weeks of treatment - 1 x week and 3 reviews 4 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start15 Jun 2022
- Primary completion16 Nov 2024 (estimated)
- Study completion16 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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
- Longitudinal, experimental qualitative and quantitative research project. Non-pharmacological, non- invasive, natural complementary therapy.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394272
- Sponsor's protocol ID
- KCH22-058
- Acronym
- ET&CP
- Status last verified
- Mar 2024
- First submitted
- 4 May 2022
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Energy Therapy in the Management of Chronic Pain and Associated Medical Condition in Children and Adolescents.
- ClinicalTrials.gov ID
- NCT05394272
- Acronym / sponsor ID
- ET&CP / KCH22-058
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 16 Nov 2024 (estimated)
- Study completion
- 16 Jun 2025 (estimated)
- First posted
- 27 May 2022 (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.
Paediatric and adolescent patients with chronic pain associated with their medical condition will be invited to participate in this study. Most patients for this study will be recruited from gastroenterology and hepatology clinics at KCH. Therefore the rationale for the study is primarily with consideration of each of these medical conditions all with the common symptom of chronic pain. Inflammatory bowel disease disorders(IBD), such as Crohn's Disease and Ulcerative Colitis, disorders of gut-brain interaction (DGBI) all experience chronic pain. however children with DGBI do not have an underlying specific lesion causing the pain. The chronic pain is the disease. In addition to this Chronic pancreatitis in children and adolescents can cause severe pain.
All of these groups of patients suffer with chronic pain and this can result in failure to thrive and have a negative impact on quality of life.
There is a need for further development of a non - pharmacological approach to support these patients with their symptoms of pain and in turn improve quality of life.
This study is designed to evaluate the benefits of a complementary natural therapy for paediatric and adolescent patients registered at King's College Hospital, with a diagnosis of a disease or disorder with associated symptoms of chronic pain. The age group is 5-18 years old.
The therapy to be evaluated is an energy therapy (Pranic Healing). This therapy is non -invasive, non- touch, non- pharmacological and natural. The study will assess the benefits these patients experience with their symptoms of pain after 8 weeks of weekly energy therapy sessions each session is 30 minutes and 3 visits each 4 weeks apart.
Qualitative and Quantitative data will be collected and evaluated.
Detailed description
Primary Objective:
The primary objective of this study is to evaluate how effective a complementary therapy, Energy Therapy (Pranic Healing) is for children and adolescents that experience chronic pain.
Secondary Objective:
To evaluate efficacy of this energy therapy in reduction in clinical symptoms/pathology associated with the child's / adolescent's medical condition causing the chronic pain.
Longitudinal, experimental qualitative and quantitative research project. Non-pharmacological, non- invasive, natural complementary therapy.
The study is a controlled trial without randomisation experimental, longitudinal study designed to evaluate the efficacy of a non - pharmacological complementary therapies for children and adolescents with chronic.All participants are patients at King' College Hospital.
Recruitment
The initial recruitment for the study will be for patients from Gastroenterology and hepatology clinics at King's College Hospital. Patients with chronic pain with other medical conditions will be recruited as study progresses.
All families will be contacted by the medical care team or via the patient database by post/email with the PIL/PIS and ET information booklet (age appropriate).
Families will be contacted via email/ telephone, those interested in participation will be invited to an informal information session virtually or face to face.
The PIS will be discussed, any concerns regarding the study will be clarified. Parents will be asked to give informed consent if they would like their child to participate.
All participants will continue with their routine medical care and treatment at King's College Hospital.
Baseline Characteristics
To be collected prior to the intervention.
Pain -Visual Analogue Scale P-VAS - to be completed for 10 days prior to first session and daily for the duration of the study
Paediatric Ulcerative Colitis Activity Index (PUCAI) questionnaire- to be completed prior to the first session, subsequently every 4 weeks for the duration of the study for those patients with Ulcerative Colitis.
Paediatric Crohn's Disease Activity Index (PCDAI) questionnaire -to be completed prior to the first session subsequently every 4 weeks for the duration of the study for those patients with Crohn's Disease.
Faecal Calprotectin (FCP) - IBD PATIENTS will give a stool sample for a FCP test prior to their first session. Parents may bring the sample with them on the first appointment.
FCP samples will then be collected every 4 weeks for the duration of the study for patients with IBD.
Amylase (Blood test /Urine sample) BT/US Baseline level from last sample - patient records, collect sample at 4 weeks 8 weeks and 20 weeks (CP patients and pts where blood test routinely collected to evaluate clinical /physical symptoms).
Height and Weight (H\&W) will be recorded at the first visit and every 4 weeks for the duration of the study for all patients.
Medication - a table recording medication dosage and frequency for abdominal pain will be requested to be completed for 10 days prior to the first session and every day throughout the study.
Journal - A diary will be given to patients /parents for young children,10 days prior to the study and for completion logging any changes through the study with pain associated with
Inflammatory Bowel Disease ( Ulcerative Colitis and Crohn's Disease) and Disorders of Gut- Brain Interaction and Chronic Pancreatitis and other medical conditions with manifestations of chronic pain 100
- Recruitment process via referral from medical care team and patient database (registered paediatric and adolescent patients with chronic pain linked with medical condition at KCH)
- Post/email PIS/PIL age appropriate information booklet
- Informal information session / patient screening
- Parent /adolescent giving consent if wishing to participate
- Letter to GP informing of participation in study.
- Letter to school /employer with dates and times of appointments where appropriate and requested.
- 10 days prior to first session P-VAS completed daily Medication table for pain daily Journal
- First appointment for Energy Therapy- prior to session PUCAI or PCDAI for IBD participants. Collection of FCP/BT/ US sample, if baseline not available in patient records. H\&W.
- Daily completion of P-VAS/medication for pain and journal
- Weekly visits for 8 weeks - 30 minutes each visit
- 4 weeks stage PUCAI/PCDAI/FCP/BT/US/H\&W to be collected.
- 8 week stage PUCAI/PCDAI/ H\&W /FCP/BT/US to be collected.
- Energy Therapy sessions to be every 4 weeks for 3 months. For the 3 visits PUCAI/PCDAI/H\&W/FCP/BT/US For the final visit BT/US collection in addition.
22 weeks
Inclusion Criteria:
Registered Paediatric patient at King's College Hospital 5-18years of age Male and Female Diagnosis of medical condition with associated chronic pain Symptoms of Pain
Exclusion Criteria
Under 5 years old and older than 18 years old
No symptoms of pain
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Longitudinal, experimental qualitative and quantitative research project. Non-pharmacological, non- invasive, natural complementary therapy.
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Energy Therapy - Pranic Healing with chronic pain | Experimental | Other: Energy Therapy - Pranic HealingEnergy therapy - Pranic Healing to be applied for 8 weeks weekly and 3 times 4 weeks apart for relief of chronic pain |
| Efficacy of Energy Therapy - Pranic Healing - with linked medical condition | Experimental | Other: Energy Therapy - Pranic HealingEnergy Therapy - Pranic Healing protocol for linked medical condition applied for 8 weeks weekly and 3 times 4 weeks apart , relevant BT/Urine sample /stool sample 4 weeks apart to evaluate changes. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Registered patients at King's College Hospital Male and Female 5-18 years old Symptoms of chronic pain associated with medical condition
Key exclusion criteria (1 listed)
- Under 5 years of age and older than 18 years No symptoms of pain
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 |
|---|---|---|
| Energy Therapy - Pranic HealingEnergy therapy - Non invasive non touch and non pharmacological - 100% natural complementary therapy | Other | Efficacy of Energy Therapy - Pranic Healing - with linked medical condition, Efficacy of Energy Therapy - Pranic Healing with chronic pain |
Primary outcome
P-VAS validated questionnaire
Time frame: 20 weeks
reduction in symptoms of chronic pain with Energy therapy
1 secondary outcome
stool samples/urine samples and blood tests
Time frame: Patient will have 8 weeks of treatment - 1 x week and 3 reviews 4 weeks apart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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.
Benjamin Hope, MBBS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Therapy - Pranic Healing in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anju Bhatia, BDS (0203 2992495, anju.bhatia@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P-VAS validated questionnaire (time frame: 20 weeks). 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 6 Mar 2024.