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Psychological Variables in Physiotherapy Treatment of Low Back Pain: A Comparison of Group and Individual Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02138071
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : October 6, 2016
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Bait Balev Hospital

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.

Condition or disease
Low Back Pain

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).

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02138071

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Maccabi Healthcare Services
Tel-Aviv, Israel
Sponsors and Collaborators
Bait Balev Hospital
Maccabi Healthcare Services, Israel
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Principal Investigator: Marina Sigal, MD Maccabi Health Service
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Responsible Party: Bait Balev Hospital Identifier: NCT02138071    
Obsolete Identifiers: NCT01640132
Other Study ID Numbers: 12/2012
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bait Balev Hospital:
low back pain
lumbar pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations