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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138071
• Other study ID #: 12/2012
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: October 5, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: June 2015
• Source: Bait Balev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT01640132

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Israel	Maccabi Healthcare Services	Tel-Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Bait Balev Hospital	Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes