Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02138071
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : October 6, 2016
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Bait Balev Hospital

Tracking Information
First Submitted Date May 13, 2014
First Posted Date May 14, 2014
Last Update Posted Date October 6, 2016
Study Start Date April 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2014)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 13, 2014)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Low Back Pain
Intervention Not Provided
Study Groups/Cohorts
  • Individual
    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)
  • group
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2016)
180
Original Estimated Enrollment
 (submitted: May 13, 2014)
200
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02138071
Other Study ID Numbers 12/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Bait Balev Hospital
Study Sponsor Bait Balev Hospital
Collaborators Maccabi Healthcare Services, Israel
Investigators
Principal Investigator: Marina Sigal, MD Maccabi Health Service
PRS Account Bait Balev Hospital
Verification Date June 2015