|- candidate number||19444|
|- NTR Number||NTR4787|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-sep-2014|
|- Secondary IDs|| |
|- Public Title||Measuring impact of Acupuncture treatment on Pain Patients’ Health Status|
|- Scientific Title||Measuring impact of Acupuncture treatment on Pain Patients’ Health Status|
|- hypothesis||The primary goal of this observational case series study is to access the changes in health status of pain patients following on acupuncture treatment. Changes will be measured by the ‘MYMOP2-online’ questionnaire. Health status is defined as the degree of pain, functional disability, subjective well being and use of medication.
The secondary goal is to investigate whether the changes in health status depend on the variability in frequency, duration, theoretical bases and modality of the acupuncture treatment.
|- Healt Condition(s) or Problem(s) studied||Pain, Acupuncture|
|- Inclusion criteria||Acupuncture patients having pain existing more than seven days; attend for acupuncture treatment voluntarily; are 16 years and older; are able to complete a Dutch online questionnaire, completed informed consent. |
Acupuncturists who work in The Netherlands for at least 2 years; have a computer in their praxis; speak the Dutch language; completed informed consent.
|- Exclusion criteria||All other patients attending acupuncturepraxis|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||15-sep-2014|
|- planned closingdate||15-apr-2015|
|- Target number of participants||250|
|- Interventions||The intervention includes Traditional Chinese Medicine; treatment with needles with eventually additional the use of moxa, massage (tuina/guasha), cupping, elektrostimulation and advice/instruction/exercises about food and lifestyle. Several theoretical bases may underlie the treatment. The acupuncturist choose or combines from a.o. ‘Zangfu’, Five Elements’, ‘Dr. Tan’s Balance Method’, ‘Stems and Branches’, ‘Ashi-points, ‘Earacupuncture’. The treatment is not invasive, which means that nothing will be changed in the usual treatment as a result of this study. In Chinese Medicine the treatment will be tailored to the personal demands and conditions of the patient. The patient will attend the praxis voluntarily. The patient is not assigned to an intervention or control group. The acupuncturist performs the treatment exactly as if no study had taken place. Measurements that will be made during acupuncture treatment reflect common clinical practice.|
|- Primary outcome||The primary outcome measure is the ‘MYMOP2-online’ change score. That is, patient reported scores (7 point scales) of successively: the pain; functional disability due to pain; general wellbeing; medication for the pain.|
|- Secondary outcome||The secondary outcome measure is the database of the acupuncture treatment. That is, frequency; duration; theory; and modality of every single acupuncture treatment.|
|- Timepoints||‘MYMOP2-online’ patient questionnaire at first appointment (T0), after four weeks (T1), after 16 weeks (T2)
Database of acupuncture treatment every single treatment.
|- Trial web site||www.mapphs.com|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. M. Vernooij|
|- CONTACT for SCIENTIFIC QUERIES||MSc. M. Vernooij|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|Nederlandse Vereniging voor Acupunctuur (NVA)|
|- Brief summary||The number of patients attending acupuncture increased and it is expected that it will rise further in the near future. The WHO is calling member states for more regulation and integration of TC&M in health care. The ICF model used by WHO shows that not the medical diagnosis should be central but rather the meaning the patient himself indicates to health and desired health benefits, as evidenced by well-being, self-reliance and participation.
The holistic approach in acupuncture, examines the whole person rather than the illness alone. No protocols, no prescribed treatment, but each individual determines, by mutual agreement, what the desired goals are, and which treatment is most appropriate at that time. There is a huge variety of health problems that people decide to attend acupuncture. |
In the present study, the impact of acupuncture on pain patients’ health status is being studied. Health status is defined as the degree of pain, functional disability, subjective well being and use of medication.
The present study will be conducted in 25 clinical acupuncture practices in the Netherlands.
In the Netherlands this study is one of the first in this field. It can be seen as a large pilot that might form the basis for more acupuncture research in the future.
|- Main changes (audit trail)||13-okt-2015: Inclusie criteria:|
Oud: are 16 years and older
New: are 15 years and older
|- RECORD||12-sep-2014 - 13-okt-2015|