None listed
Conditions
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.
Interventions
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 d
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.
Sponsors
Samuel Kim
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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
Outcome results
None listed