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

Psychological Variables in Physiotherapy Treatment for LBP: a Comparison Between Individual and Gruop Treatment

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.

Study Overview

• Status: Completed
• Conditions: 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).

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Maccabi Healthcare Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lumbar functional status	participants are asked to fill the LFSQ - lumbar functional status questionnaire before and after tretment completion and after 6 months	at first and last visit and after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients' perception on how they have been helped	data for this outcome measure will be collected through a telephone interview	in two weeks after the last visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of pain = NRPS	self perception of patients' level of pain will be collected through the NRPSQ=numeric rate pain scale questionnaire	before and after treatment and after 6 months
fear avoidance beliefs = FABS	FABS Questionnaire will be used to assess the level of fear of physical activity	before and after last treatment and after 6 months

Collaborators and Investigators

• Sponsor: Bait Balev Hospital
• Collaborators: Maccabi Healthcare Services, Israel
• Investigators: Principal Investigator: Marina Sigal, MD, Maccabi Health Service

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: low back pain; lumbar pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 12/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No