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Trial registered on ANZCTR


Registration number
ACTRN12616000960459p
Ethics application status
Submitted, not yet approved
Date submitted
16/07/2016
Date registered
21/07/2016
Date last updated
28/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of chakra-puncture (CP) in addition to standard treatment for impaired sleep rhythm and disorders of breathing associated with chronic body pains.
Scientific title
Prospective randomised crossover study of chakra-puncture (CP) and medical treatments with medical treatments alone in impaired sleep rhythm and sleep-disordered breathing (SDB) associated with chronic body pains
Secondary ID [1] 289693 0
None
Universal Trial Number (UTN)
U1111-1185-4383
Trial acronym
HEAL-1 Study:
(cHakra-puncture in sLeep & pAin Longitudinal Study): - Phase I Clinical Investigation study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired sleep rhythm 299494 0
Sleep-disordered breathing (SDB) 299495 0
Chronic body pain 299496 0
Condition category
Condition code
Respiratory 299479 299479 0 0
Other respiratory disorders / diseases
Musculoskeletal 299480 299480 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 299481 299481 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chakra-puncture (CP) is a highly innovative, minimally invasive and reproducible complementary healing modality which uses less than 0.2 to 0.4 mm skin penetration via thin single-use acupuncture needles. The HEAL-1 Study is a prospective randomised crossover clinical trial of up to 80 participants from the general population aged 18 to 65 of equal gender who report impaired sleep rhythm and/or symptoms of sleep-disordered breathing (SDB) in presence of chronic body pains unrelated to a prior diagnosis of autoimmune disease or chronic trauma. These participants will be randomised to either chakra-puncture (CP) with medical treatments or medical treatments alone for the duration of 6 weeks then treatment will be reversed after a washout period of 4 weeks. The CP treatments will be a total of three sessions with each session composed of a generic configuration of one hour duration at a fortnightly interval which will be administered by a roster of accredited CP practitioner(s). These practitioners will be blinded to the treatment sequence or the participant's detail of diagnosis and treatment.. The maximum number of the CP needles will be 22 which will be left intact for up to 45 minutes in one hour per session which includes participant preparation and completion of treatment summary. The 'generic' configuration is designed for body supportive treatment of anxiousness and sleep which is inclusive of the support for the vascular, lymphatic and endocrine systems as per the current published curriculum of CP training in its basic form.. The minimum level of accredited training required for a practitioner is 12 months of Diploma of CP education with a minimum of 100 hours of supervised practical experience. Treatment completion and study follow up will closely monitored for adherence via reminder phone call and follow up study visits by a dedicated study nurse. All participants will receive the standard medical treatment following diagnostic polysomnography screening. The nominated Principal Investigator will ensure optimal training and implementation of level 2 overnight diagnostic polysomnography and ancillary diagnostic testing during and following the CP treatments. At the time of study completion, comprehensive qualitative and quantitative physiological measures of sleep and pain will be collected from each participants throughout the study to document the clinical effects of CP in impaired sleep and chronic body pain.
Intervention code [1] 295314 0
Treatment: Devices
Intervention code [2] 295337 0
Treatment: Other
Comparator / control treatment
Due to the crossover study design, each participant act as his or her own control within the clinical study. At the time of study enrolment, diagnostic polysomnographic screening will screen for the underlying sleep rhythm disturbance and/or sleep-disordered breathing (SDB).. Accordingly, each participant will be treated with the usual standard of medical care such as continuation of their usual medication including analgesia, sleep hygiene advice and dietary modification for impaired sleep rhythm and/or SDB irrespective of whether or not the chakra-puncture (CP) is offered in addition to the medical treatment. The participants who require a definitive CPAP treatment due to severity of SDB such as symptomatic obstructive sleep apnoea (OSA) will be analysed as a subgroup within the intention-to-treat (ITT) analysis.
Control group
Active

Outcomes
Primary outcome [1] 298957 0
Changes in the overall McGil Pain Score (qualitative pain descriptors of up to seven words to describe pain)
Timepoint [1] 298957 0
Week 1 - time of study enrolment post-randomisation
Week 7 - post-initial treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Week 17 - post-crossover treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Primary outcome [2] 298958 0
Changes in global PSQI sleep quality score (>5 if worse quality) and Epworth Sleepiness Score (ESS>11 for excessive sleepiness)

Please note: Both PSQI and ESS are composite outcomes for determining the overall trend in the participant's quality of sleep given the limitations of a single measure alone. Whilst the PSQI global score of greater than 5 and/or ESS score of greater 11 is defined as 'abnormal' as per the published literature, the study is examining the differences in the overall change of the scores to support the changes in sleep quality with CP and standard medical treatment or standard medical treatment alone.
Timepoint [2] 298958 0
Week 1 - time of study enrolment post-randomisation
Week 7 - post-initiai treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Week 17 - post-crossover treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Primary outcome [3] 298959 0
Changes in global and selected SF-36 QOL (quality of life) indices (ranging of 0-100 from the eight different domains)
Timepoint [3] 298959 0
Week 1 - time of study enrolment post-randomisation
Week 7 - post-intiai treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Week 17 - post-crossover treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Secondary outcome [1] 325763 0
Changes in polysomnographic and sleep diary parameters (apnoea-hypopnoea index, quantitation of sleep fragmentation, nadir room air desaturation, total duration of sleep, sleep onset and REM sleep latency)

Please note: Given the space limitations, these summarise composite outcomes which are part of a complex level 2 or 3 diagnostic polysomnography and sleep diary.
Timepoint [1] 325763 0
Week 1 - time of study enrolment post-randomisation
Week 7 - post-intiai treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Week 17 - post-crossover treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Secondary outcome [2] 325764 0
Changes in physiological parameters (body thermographic pattern for localised body pain using high-resolution thermographic camera from Testo Australia, ambulatory blood pressure profile using 24-hour ABPM device from Norav, regional EEG patterns via minimally invasive wireless Emotive EEG unit)

Please note: Given the space limitations, these summarise composite outcomes which are part of the three key ancillary physiological and diagnostic measurements.
Timepoint [2] 325764 0
Week 1 - time of study enrolment post-randomisation
Week 7 - post-intiai treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)
Week 17 - post-crossover treatment completion (either medical treatment or chakra-puncture (CP) and medical treatment)

Eligibility
Key inclusion criteria
1. Adults aged 18 to 65 years
2. Both genders
3. Able to give informed verbal consent
4. Require to have a sufficient level of education to understand study procedures and communicate with research personnel
5. Time availability to attend chakra-puncture (CP) treatments and follow up period.
6. Documented history of poor perceived quality of sleep with chronic body pains unrelated to diagnosis of autoimmune disorder and/or previously treated sleep-disordered breathing (SDB).

For the purpose of the study, the impaired sleep rhythm will be defined as per the perceived symptoms of uncontrolled sleeplessness or sleepiness, and correlated to the screening sleep diary and baseline ambulatory actigraphy at the time of enrolment. Specific sleep rhythm disorders will be defined as per the International Classification of Diseases (ICD-1-CM, 2014) and the American Sleep Association (ASA).

Chronic body pain is defined as either localised or generalised body pain which is associated with impaired sleep rhythm, impaired sleep duration and pattern which is of a longer than six months in duration in absence of pre-existing chronic musculoskeletal trauma or confirmed diagnosis of autoimmune disease.

McGilll Pain Questionnaire, PSQI and ESS will be performed for eligible participant by the nominated Principle Investigator to define as per the Inclusion and Exclusion Criteria. Following the completion of Informed Consent and study enrolment, two-weeks of baseline sleep diary, ambulatory actigraphy and overnight level 2 diagnostic polysomnography will be completed for full evaluation and medical treatment formulation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability or unwillingness to give written informed consent
2. Pregnancy or planning to become pregnant
3. Actively breast-feeding
4. Terminal illness due to advanced organ failure and/or cancer
5. History of uncontrolled substance abuse such as alcohol, marijuana and/or psychostimulant such as amphetamines
6. Use of regular sedatives such as Benzodiazepines, Barbiturates or Melatonin and its biological analogues
7. Concomitant use of Complementary Medicines such as homeopathic formulations, acupuncture, Bowen therapy, Reiki healing, chiropractic manipulations or craniosacral massage
8. Participation in a study of an investigational medication within the past 30 days
9. Presence of active undiagnosed skin disease or lesions
10. Presence of severe physical disability including uncontrolled nocturnal fecal and/or urinary incontinence, which would interfere with the logistics of treatment interventions and monitoring
11. Chronic body pains associated with primary diagnosis of uncontrolled autoimmune disorder such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjogren’s syndrome or sarcoidosis
12. Use of continuous positive airway pressure (CPAP), mandibular advancement splint (MAS) or previous history of upper laryngeal surgery such as UPPP (uvulopalatopharyngoplasty) for previously diagnosed sleep-disordered breathing (SDB)
13. History of psychoses, or uncontrolled depressive disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study is a community-based clinical study in which all eligible participants are stratified then allocated via central computerised randomisation via the study coordinating centre into either chakra-puncture (CP) and medical treatment or medical treatment alone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by the central coordinating computer using. computerised sequence generation will be used for the study. All eligible participants will be stratified according to the site of enrolment, age, gender, previous/current medical treatment and previous chakra-puncture (CP) exposure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
A 'washout' period of four weeks is included between the two treatment sequence for each participant in the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Confounding variables include the effect of age, gender and medical comorbidity, which are adjusted in participant stratification at the commencement of the study. Specific subgroup (or ‘cluster’) analysis will be performed for participants who share similar baseline phenotypic data and/or post-treatment effect within the intention-to-treat (ITT) analysis.

Descriptive statistics will summarise the quantitative descriptions of the study population before, during and following chakra-puncture (CP) and/or medical treatment. Univariate analysis will examine each of the important symptom variables of pain, sleep and physiological sleep and movement data for the differences in the distribution, central tendency and dispersion.

Given the two-group post-test randomised experimental model of the crossover study, the measured differences between the means of the specific measured outcomes will be analysed via unpaired T-test or one-way ANOVA assuming a statistical significance (alpha) of 0.05, power (1-beta) of 0.80, drop-out rate of 10% and minimal detectable difference in means (MDD) of sleep and and/or chronic pain of 1. The ‘true effect’ size (t-value) will be calculated for the study population from the ratio of the differences between group means and the variability of groups and applied to inferential statistics.

Inferential statistics will be utilised to derive objective conclusion of the study population using multivariate analysis and general linear model including the t-test, analysis of variance (ANOVA), analysis of covariance (ANCOVA), and regression analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 13615 0
2480 - Goonellabah
Recruitment postcode(s) [2] 13616 0
4000 - Spring Hill

Funding & Sponsors
Funding source category [1] 294072 0
Other
Name [1] 294072 0
Blue Hills Lung Centre P/L
Country [1] 294072 0
Australia
Primary sponsor type
Individual
Name
Samuel Kim
Address
Dr Samuel Kim MBBS (Qld) FRACP MPH MBA
Thoracic & Sleep Physician, Integrative Pulmonary Care & Medical P/L
Senior Lecturer, University of Queensland, UnitingCare Health Clinical School
Suite 287-288 Ground Floor
33 North Street
Spring Hill QLD 4000
Country
Australia
Secondary sponsor category [1] 292903 0
Individual
Name [1] 292903 0
Serge Benhayon
Address [1] 292903 0
Evolve College
15 Blue Hills Avenue
GOONELLABAH NSW 2480
Country [1] 292903 0
Australia
Other collaborator category [1] 279085 0
Other
Name [1] 279085 0
Evolve College
Address [1] 279085 0
98 York Street
South Melbourne VIC 3205
Country [1] 279085 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295486 0
University of Queensland Human Ethics Unit
Ethics committee address [1] 295486 0
University of Queensland Human Ethics Unit
St. Lucia BRISBANE QLD 4072
Ethics committee country [1] 295486 0
Australia
Date submitted for ethics approval [1] 295486 0
19/07/2016
Approval date [1] 295486 0
Ethics approval number [1] 295486 0

Summary
Brief summary
The primary objective of the study is to collect ‘real-world’ data on patients undergoing medical treatments with chakra-puncture (CP) or medical treatments alone in impaired sleep rhythm and/or sleep-disordered breathing (SDB) with chronic body pains.

There are two main hypotheses assessed by the study: firstly, the experimental treatment with CP and medical treatments result in 20% or greater reduction in perceived body pains, and objective improvement in self-perception of quality of sleep over a six-months of follow up as compared to the medical treatments alone. Secondly, the improvements in chronic body pains and quality of sleep correspond to a significant reduction in abnormal body movements during sleep, which is associated with objective changes in sleep-related and daytime physiological markers.

The study is a crossover-randomised study which will be completed over a period of 16 weeks, which is inclusive of participant recruitment, stratification, central randomisation, treatment and follow up. All relevant baseline physiological and demographic data will be collected at the time of randomisation. All participant-specific data will be de-identified to protect participant confidentiality and maintained in a safe data storage facility. Up to 80 participants will be randomly allocated to either consecutive generic CP treatments at 2-weekly intervals along with their medical treatment or medical treatment alone. After the initial treatments over a period of 6 weeks, a ‘wash-out’ period of four weeks will be given before the treatment sequence is reversed for each participant.

Upon the study completion, a comparative analysis will be performed for clinical and statistical significance. Significant changes in impaired sleep rhythm and body pain will be summarised both by the percentage proportion (%) of participants experiencing at least 20% or more change in baseline sleep rhythm, pain scores and physiological markers at Week 1, 3, 5, 7, 10 and 17 of the study. Additional outcome analysis will be performed for adverse events, regional EEG patterns, quantitative core body temperature changes in localised areas of pain, participant satisfaction survey and QOL questionnaires, serial actigraphy and polysomnographic parameters, and nocturnal sleep-related movement data.

To date, there is no published literature on the application of CP in neurocognitive research and treatment of impaired sleep rhythm associated with or without chronic body pains through a well-designed clinical study. The minimally invasive nature of the CP offers a potentially important avenue of non-pharmacological treatments.
Trial website
To be advised
Trial related presentations / publications
To be published upon the study completion:
Public notes

Contacts
Principal investigator
Name 67462 0
Dr Samuel Kim
Address 67462 0
Thoracic & Sleep Physician, Integrative Pulmonary & Care Medical P/L
Senior Lecturer, University of Queensland, UnitingCare Health Clinical School
Suite 287-288 Ground Floor
33 North Street
SPRING HILL QLD 4000
Country 67462 0
Australia
Phone 67462 0
+61738391863
Fax 67462 0
+61738391864
Email 67462 0
[email protected]
Contact person for public queries
Name 67463 0
Serge Benhayon
Address 67463 0
Director of Evolve College
15 Blue Hills Avenue
GOONELLBAH NSW 2480
Country 67463 0
Australia
Phone 67463 0
+61266243706
Fax 67463 0
+61266243702
Email 67463 0
[email protected]
Contact person for scientific queries
Name 67464 0
Samuel Kim
Address 67464 0
Thoracic & Sleep Physician, Integrative Pulmonary & Care Medical P/L
Senior Lecturer, University of Queensland, UnitingCare Health Clinical School
Suite 287-288 Ground Floor
33 North Street
SPRING HILL QLD 4000
Country 67464 0
Australia
Phone 67464 0
+61738391863
Fax 67464 0
+61738391864
Email 67464 0
[email protected]

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