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NCT Number: NCT02138071

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maccabi Healthcare Services

Tel Aviv, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. lumbar functional status

    Time frame: at first and last visit and after 6 months

    participants are asked to fill the LFSQ - lumbar functional status questionnaire before and after tretment completion and after 6 months

Secondary outcomes

  1. patients' perception on how they have been helped

    Time frame: in two weeks after the last visit

    data for this outcome measure will be collected through a telephone interview

Other outcomes

  1. level of pain = NRPS

    Time frame: before and after treatment and after 6 months

    self perception of patients' level of pain will be collected through the NRPSQ=numeric rate pain scale questionnaire

  2. fear avoidance beliefs = FABS

    Time frame: before and after last treatment and after 6 months

    FABS Questionnaire will be used to assess the level of fear of physical activity

Sponsors and collaborators

Lead sponsor

Bait Balev Hospital

Other

Collaborators

  • Maccabi Healthcare Services, Israel

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 14, 2014
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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