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

This study has been completed.
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Bait Balev Hospital
ClinicalTrials.gov Identifier:
NCT02138071
First received: May 13, 2014
Last updated: October 5, 2016
Last verified: June 2015
  Purpose
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
Low Back Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological Variables in Physiotherapy Treatment for LBP: a Comparison Between Individual and Gruop Treatment

Resource links provided by NLM:


Further study details as provided by Bait Balev Hospital:

Primary Outcome Measures:
  • lumbar functional status [ Time Frame: at first and last visit and after 6 months ] [ Designated as safety issue: Yes ]
    participants are asked to fill the LFSQ - lumbar functional status questionnaire before and after tretment completion and after 6 months


Secondary Outcome Measures:
  • patients' perception on how they have been helped [ Time Frame: in two weeks after the last visit ] [ Designated as safety issue: Yes ]
    data for this outcome measure will be collected through a telephone interview


Other Outcome Measures:
  • level of pain = NRPS [ Time Frame: before and after treatment and after 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    FABS Questionnaire will be used to assess the level of fear of physical activity


Enrollment: 180
Study Start Date: April 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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.

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02138071

Locations
Israel
Maccabi Healthcare Services
Tel-Aviv, Israel
Sponsors and Collaborators
Bait Balev Hospital
Maccabi Healthcare Services, Israel
Investigators
Principal Investigator: Marina Sigal, MD Maccabi Health Service
  More Information

Responsible Party: Bait Balev Hospital
ClinicalTrials.gov Identifier: NCT02138071     History of Changes
Obsolete Identifiers: NCT01640132
Other Study ID Numbers: 12/2012 
Study First Received: May 13, 2014
Last Updated: October 5, 2016
Health Authority: Israel: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Bait Balev Hospital:
low back pain
lumbar pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016