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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]

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

Sleep-disordered breathing (SDB)

Chronic body pain

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Musculoskeletal

Other muscular and skeletal disorders

Alternative and Complementary Medicine

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]

Treatment: Devices

Intervention code [2]

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]

Changes in the overall McGil Pain Score (qualitative pain descriptors of up to seven words to describe pain)

Timepoint [1]

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]

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]

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]

Changes in global and selected SF-36 QOL (quality of life) indices (ranging of 0-100 from the eight different domains)

Timepoint [3]

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]

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]

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment postcode(s) [1]

2480 - Goonellabah

Recruitment postcode(s) [2]

4000 - Spring Hill

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Blue Hills Lung Centre P/L

Address [1]

Suite 287-288 Ground Floor
33 North Street
Spring Hill QLD 4000

Country [1]

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]

Individual

Name [1]

Serge Benhayon

Address [1]

Evolve College
15 Blue Hills Avenue
GOONELLABAH NSW 2480

Country [1]

Australia

Other collaborator category [1]

Other

Name [1]

Evolve College

Address [1]

98 York Street
South Melbourne VIC 3205

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

University of Queensland Human Ethics Unit

Ethics committee address [1]

University of Queensland Human Ethics Unit
St. Lucia BRISBANE QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/07/2016

Approval date [1]

Ethics approval number [1]

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

Dr Samuel Kim

Address

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

Phone

+61738391863

Fax

+61738391864

[email protected]

Contact person for public queries

Name

Serge Benhayon

Address

Director of Evolve College
15 Blue Hills Avenue
GOONELLBAH NSW 2480

Country

Australia

Phone

+61266243706

Fax

+61266243702

[email protected]

Contact person for scientific queries

Name

Samuel Kim

Address

Country

Australia

Phone

+61738391863

Fax

+61738391864

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically