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

NCT ID: NCT02138071

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-03-31

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).

Conditions

Low Back Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

Bait Balev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Sigal, MD

Role: PRINCIPAL_INVESTIGATOR

Maccabi Health Service

Locations

Maccabi Healthcare Services

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

12/2012

Identifier Type: -

Identifier Source: org_study_id

NCT01640132

Identifier Type: -

Identifier Source: nct_alias