Psychological Variables in Physiotherapy Treatment of Low Back Pain: A Comparison of Group and Individual Treatment
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|ClinicalTrials.gov Identifier: NCT02138071|
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : October 6, 2016
|Condition or disease|
|Low Back Pain|
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).
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Official Title:||Psychological Variables in Physiotherapy Treatment for LBP: a Comparison Between Individual and Gruop Treatment|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Treatment in the 'Individual group therapy' will include physiotherapy protocols usually used by physiotherapist working at Maccabi Healthcare Services (Exercises, Modalities, Maual therapy and Back Care education)
Participants in group therapy will receive 6-8 group treatments (6-12 pateints per group) which will also include exercises and back-care education. No intervention will be done by the investigator.Therapists will use protocols commonly used in Maccabi Healthcate Services.
- lumbar functional status [ Time Frame: at first and last visit and after 6 months ]participants are asked to fill the LFSQ - lumbar functional status questionnaire before and after tretment completion and after 6 months
- patients' perception on how they have been helped [ Time Frame: in two weeks after the last visit ]data for this outcome measure will be collected through a telephone interview
- level of pain = NRPS [ Time Frame: before and after treatment and after 6 months ]self perception of patients' level of pain will be collected through the NRPSQ=numeric rate pain scale questionnaire
- fear avoidance beliefs = FABS [ Time Frame: before and after last treatment and after 6 months ]FABS Questionnaire will be used to assess the level of fear of physical activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138071
|Maccabi Healthcare Services|
|Principal Investigator:||Marina Sigal, MD||Maccabi Health Service|