|- candidate number||25854|
|- NTR Number||NTR6250|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-dec-2016|
|- Secondary IDs||K15-07 MEC|
|- Public Title||Effectiveness of group therapy in a functional setting, compared to usual physiotherapy treatment protocols for non-specific chronic low back pain patients|
|- Scientific Title||Effectiveness of group therapy in a functional setting, compared to usual physiotherapy treatment protocols for non-specific chronic low back pain patients: A Quasi experimental design|
|- hypothesis||1. This study will investigate if the group therapy is effective based on the functional outcome variables (pain, mobility, activity and disability) in patients with non-specific chronic low back pain.|
2. This study will compare the effectiveness of the outcome variables (pain, mobility and activity) of the group therapy versus usual physiotherapy in patients with non-specific chronic low back pain.
3. This study will compare the cost-effectiveness between the group therapy versus the usual physiotherapy treatment in patients with non-specific chronic low back pain.
|- Healt Condition(s) or Problem(s) studied||Nonspecific low back pain, Physiotherapy, Group therapy|
|- Inclusion criteria||chronic non-specific low back pain (duration of >3 months), presently seeking care for low back pain, between 18 and 80 years of age, screening to indicated that the patient was suitable for active exercises, available during 5 weeks, had at least a VAS score greater than 1. |
|- Exclusion criteria||specific low back pain diagnosis, such as radicular pain, disc herniation, spondylolisthesis, infection, tumour, stenosis, Scheurmannís disease and rheumatic problems, limb or lumbar spine surgery in last 3 months, pregnancy or instructed by a general practitioner or medical specialist not to perform physically activities. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||16-feb-2015|
|- planned closingdate||8-aug-2015|
|- Target number of participants||91|
|- Interventions||The intervention group, consists of group therapy (a combination of anatomy lessons, lessons in behavioural principles and exercise therapy).|
In the intervention group patients attended up for 5 treatment sessions, followed once a week over a 5 week period. Each session lasted approximately one hour. The participants were trained by a physiotherapist in group sessions delivered in a gym. In total there were 13 different hours planned per week, so patients were eligible to decide when to participate. The group consisted of 5-10 patients. The level of exercises progressed over the 5 weeks period. Every session consisted of a changed content wherein awareness and self-management played a central role
In the control group (active) patients were treated individually according to the low back pain guidelines of the KNGF the Dutch college for physiotherapy.
The frequentie was on average 13 for the control group and the duration per treatment 25 minutes.
|- Primary outcome||pain measured by VAS (0-10)|
Mobility was measured with the fingertip to floor
|- Secondary outcome||patient specific measure of function (PSK) |
and Roland Morris Disability Questionnaire (RDQ)
|- Timepoints||Timepoints: |
Before treatment (pre-test)
after treatment (post-test)
1 month follow up
1 year follow up
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Carolien Gerritsen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Harry van der Kaap|
|- Sponsor/Initiator ||University of Twente - Department of Health Science|
(Source(s) of Monetary or Material Support)
|- Brief summary||Concluding, the functional group therapy seems to be cost effective compared to usual physiotherapy for patients with non-specific chronic low back pain in this study. For further research in this field it is recommended to conduct a study with homogenous groups at baseline with a larger sample or to repeat the study as a randomized controlled trial to obtain equal groups at baseline.|
Depending on clinical conditions, therapy applied to the intervention group including anatomy lessons and strengthen the inner stabilizers of the lumbar spine could be advised in order to save money.
The patients were recruited in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||30-dec-2016 - 29-apr-2017|