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

NCT02138071 | Completed DMC

• 1 other identifier: 12/2012
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; lumbar pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• patients' perception on how they have been helped

  in two weeks after the last visit

Other Outcomes (2)

• level of pain = NRPS

  before and after treatment and after 6 months

• fear avoidance beliefs = FABS

  before and after last treatment and after 6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Low back pain,
• years old and older
• Hebrew speakers , who filled the LFSQ (Lumbar Functional Status Questionnaire) at first visit
• Agreed to participate in this study

You may not qualify if:

• Pregnant
• After back or hip operation in the last year
• Back problem from non- orthopedic origin

Sponsors & Collaborators

• Bait Balev Hospital: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

Maccabi Healthcare Services

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Sigal, MD

  Maccabi Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 14, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2015-06

Locations

IL (1)