In the proposed study we wish to investigate whether orthomanual treatment is of additional value in the treatment of a population of patients with chronic low back pain. We aim to recruit a population that has been referred for evaluation to theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
standsafwijkingen van de wervelkolom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures after 3, 6, and 12 months
Pain: VAS
Backspecific function: Roland Morris Disability Questionnaire
5 scale general measure of change
Secondary outcome
Outcome measures after 3, 6, and 12 months
Generic scale: Euroqol
Other treatments (out of protocol) and side effects will be recorded
Background summary
Orthomanual medicine is a manipulative treatment that has been developed in the
Netherlands. The technique is frequently used in the treatment of chronic low
back pain. A large observational study was conducted which had a short
follow-up period and which used only limited measurement instruments. In this
study about 3/4 of the patients reported an improvement of their complaints.
This result is compatible with the experience of orthomanual physicians that
the technique seems to be effective in the treatment of patients with long
standing low back pain that has shown to be refractory to other types of
(manipulative) treatment.
Study objective
In the proposed study we wish to investigate whether orthomanual treatment is
of additional value in the treatment of a population of patients with chronic
low back pain. We aim to recruit a population that has been referred for
evaluation to the painclinic, because these patients will generally have long
standing complaints that have shown to be refractory to the usual first-line
interventions.
Study design
Randomized controlled trial
Intervention
Intervention 1: usual care by painclinic
Intervention 2: usual care by painclinic + orthomanual treatment
Study burden and risks
Burden:
Next to the painclinic treatment patients in the interventiongroup will be
referred to an orthomanual physician. The first consultation will be sceduled
within three weeks after inclusion. A normal medical history and a normal
medical examination will be conducted, together with the orthomanual
examination, mainly to verify the possibility to treat the patient by
orthomanual techniques, and to reconfirm in- and exclusioncriteria. Generally a
series of 5-7 treatments is needed for a first correction. After three months
the patient should be re-examined and in many cases a few corrections have to
be repeated. If the treatment has been effective patients are advised to
consult their physician only when complaits return. If the treatment has been
uneffective it is possible that further treatment is advised. Generally 8-10
sessions of approximately 20 min. are needed in the first year.
Risk:
There is some literature about possible adverse effects of manipulative
treatment in general. It shows that minor side effects, like temporary
dizziness, are common after manipulation of the cervical spine, but that
serious side effects are extremely rare. Reported side effects most frequently
result from rotatory HVT techniques that are not used in orthomanual treatment.
(savety reporting p. 8)
van der Boechorststraat 7
1081 BT Amsterdam
NL
van der Boechorststraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
non specific low back pain
duration at least 3 months
able to answer questionnaires in Dutch
no previous orthomanual treatment
Exclusion criteria
contraindications for manipulation
specific low back pain
condition influencing treatment or outcome
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL22636.029.08 |