Clinical trial NCT02138071: Psychological Variables in Physiotherapy Treatment of Low Back Pain: A Comparison of Group and Individual Treatment
Official title: Psychological Variables in Physiotherapy Treatment for LBP: a Comparison Between Individual and Gruop Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: low back pain
lumbar pain
Lead sponsor: Bait Balev Hospital
Sponsor class: OTHER
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2014-05-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults (18 years old and older) seeking for physiotherpy treatment for low back pain in one of the 15 clinics participating in this study

Brief summary: The purpose of the study is to determent whether there is a difference between two types of treatments in physiotherapy (individual vs group) for patients with low back pain (LBP), in terms of their sensation of how they have been helped and their treatments' outcomes measures. The study hypothesizes are: a) Based on the results of literature review which does not reveal a clear difference between group and individual treatments' outcomes for LBP, it is hypothesized that no difference will be found in treatment results for the two types of group treatments in the present study also, b) The assumption is that different distribution of therapeutic factors will be found in the two types of treatments (individual, group), C) Patients' sensation of how they have been helped will be connected to treatment results.

Detailed description: 200 patients with LBP looking for physiotherapy treatment in 15 clinics at Maccabi Healthcare Service in Israel will be recruited. (100 after competion individual therapy, 100 after competion of group therapy). As part of the regular routine in these clinics, patients will be asked to fill the LFSQ, a questionnaire which deals with their back functional status, their level of pain and fear avoidance of physical activity before and after treatment. In the present study, patients will be asked to fill the LFSQ again, 6 months after treatment completion. In two weeks from treatment completion, patients will be interviewed on the telephone. The interview will focuse on their sensation of how they have been helped. It will include an open-ended question and 18 closed questions.

The main study variables will include: participants' perception of functional status, level pain, level of fear avoidance of physical activity, patient-therapist bonding, and helpful therapeutic impacts (client's sense of how she or he has been helped).

Eligibility criteria: Inclusion Criteria:

* Low back pain,
* 18 years old and older
* Hebrew speakers , who filled the LFSQ (Lumbar Functional Status Questionnaire) at first visit
* Agreed to participate in this study

Exclusion Criteria:

* Pregnant
* After back or hip operation in the last year
* Back problem from non- orthopedic origin

Primary outcomes:
measure: lumbar functional status
timeFrame: at first and last visit and after 6 months
Secondary outcomes:
measure: patients' perception on how they have been helped
timeFrame: in two weeks after the last visit
Other outcomes:
measure: level of pain = NRPS
timeFrame: before and after treatment and after 6 months
measure: fear avoidance beliefs = FABS
timeFrame: before and after last treatment and after 6 months
Locations:
city: Tel-Aviv
country: Israel
facility: Maccabi Healthcare Services
Study officials:
affiliation: Maccabi Health Service
name: Marina Sigal, MD
role: PRINCIPAL_INVESTIGATOR
References: