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Psychological Variables in Physiotherapy for Chronic Low Back Pain:a Comparison of Group and Individual Treatment (pv-lbp-pt)

This study is currently recruiting participants.
Verified April 2012 by Assuta Hospital Systems
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01640132
First received: June 3, 2012
Last updated: April 14, 2013
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to compare the therapeutic factors, processes and outcomes in individual physiotherapy treatment vs. group physiotherapy treatment, for chronic low-back-pain.

Chronic low-back-pain (CLBP) is a common, disabling and costly problem. International guidelines recommend active physiotherapy, a treatment which emphasizes exercise as a key component in CLBP management. This type of physiotherapy treatment is mostly given individually.

There is growing literature on psychological approaches to the understanding and treatment of unexplained chronic back pain. Research regarding the most helpful psychological therapeutic factors perceived by patients reveals that the main factors expected to affect outcomes are "patient-therapist bond" and "treatment satisfaction".

In group therapy, additional processes may affect the treatment's outcomes. For example, support given by other members in the group, and cohesion to the group. However, there is paucity of data whether these processes and therapeutic factors can be found in physiotherapy treatments, whether they relate to treatment results, and is there a difference when CLBP is being treated individually versus in a group.

The current study aims to compare processes and outcomes in the short and long term of individual and group physiotherapy in an outpatient setting.


Condition Intervention
Low Back Pain
 Behavioral: 2 types of physiotherapy treatment- individual and group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychological Variables in Physiotherapy Treatment of Low Back Pain: Comparison of Group vs. Individual Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • Lumbar function [ Time Frame: Average time per patient - 8 months, total time of data collection - 2 years ] [ Designated as safety issue: No ]

    Lumbar function will be measured at four points of the study:

    1. At the beginning of treatment
    2. Mid-treatment (an average of 3-4 weeks from the beginning)
    3. At the end of treatment (6 weeks from,the beginning of group treatment, and an average of 8 weeks from the beginning of the individual treatment.
    4. Six months from completion of treatment.Change from baseline in functional status (FS) will be measured by the lumbar computerized adaptive test (LCAT) wich consists on 25 items on a scale that ranges from 0 (low) to 100 (high functioning).


Secondary Outcome Measures:
  • NRPS- numeric rate pain scale [ Time Frame: Average time per patient - 8 months, total time of data collection - 2 years ] [ Designated as safety issue: No ]

    NRPS will be measured at four points of the study:

    At the beginning of treatment Mid-treatment (an average of 3-4 weeks from the beginning), At the end of treatment (6 weeks from the beginning of group treatment, and an average of 8 weeks from the beginning of the individual treatment), Six months after treatment completion, Change from baseline in level of pain will be measured using one question "What is the level of your pain on a scale of 0 (no pain) - 10 (unbearable pain)


  • FABS-PA: fear avoidance beliefs- physical activity [ Time Frame: Average time per patient - 8 months, total time of data collection - 2 years ] [ Designated as safety issue: No ]
    At the beginning of treatment, Mid-treatment (an average of 3-4 weeks from the beginning), At the end of treatment (6 weeks from the beginning of group treatment, and an average of 8 weeks from the beginning of the individual treatment), Six months after treatment completion, Level of FABS will be measured using a 4 item questionnaire on a scale of 0 (no fear) - 100 (high )with a cut point at 44/100 representing high/low level fear. Change in level of FABS will be measured in addition to cut score, expecting a decrease to low level at least in 50% of the patients who began with high level.

  • Patient-Therapist Bond [ Time Frame: Will be measured once, at the end of the last treatment. An avarage duration of treatment expected - 6 weeks. ] [ Designated as safety issue: No ]
    Therapeutic bonding will be measured by the 'Working Alliance Inventory' (WAI)which consists of 12 items with a bonding scale on a Likert scale of 1-7. (e.g. "I believe the therapist cares about my health", "I don't feel comfortable to ask questions").

  • Therapeutic Factors [ Time Frame: Will be measured once, at the end of the last treatment, an avarage duration of treatment expected - 6 weeks ] [ Designated as safety issue: No ]
    The 'Critical Incident Questionnaire' (CIQ)will be used to identify the most important events and meaningful processes for participants in each type of treatment (group/individual). Participants will be ask to answer one open-ended question. The content will be analyzed with the Group Counseling Helping Impact Scale (GHIS)in order to capture the therapeutic factors in the therapy process.

  • Therapeutic bonding with group members [ Time Frame: At the end of group treatment - 6 weeks after the first group meeting. ] [ Designated as safety issue: No ]
    The physical Activity Group Environment Questionnaire (PAGEQ)which consists on 11 items (on a 1-7 Likert scale)will be used to measure the relationship among group participants and satisfaction from the treatment (e.g. "I like the program of physical activity done in this group","I like meeting the people who come to this physical activity group").


Estimated Enrollment: 180
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counseling
The intervention weel be given in two conditions: an individual and group physiotherapy for chronic low-back-pain.
 Behavioral: 2 types of physiotherapy treatment- individual and group

CLBP patients, not classified as 'derangement with centralization', according to Mckenzie method, will be randomly assigned to group, or individual (n=90) physiotherapy. In both conditions participants will be given a psycho-educational treatment and common physiotherapy protocol. The treatment will include discussions on theoretical issues i.e. back-care, pain- management and fear avoidance beliefs. Group-treated patients will receive 6 weekly meetings. Those being treated individually will receive individual designed program which is commonly used in physiotherapy.

The treatment stresses supportive counseling and patient education. The treatment is based on the Carl Rogers humanistic approach which places the patient's here-and-now in the center and aims to solve the patient's current problem.

All of the therapists in this study will be qualified physiotherapists and have been trained in physiotherapy group leading.
Active Comparator: Lifestyle counseling in a group setting
physiotherapy treatment will be given in a group of 10 participants
 Behavioral: 2 types of physiotherapy treatment- individual and group

CLBP patients, not classified as 'derangement with centralization', according to Mckenzie method, will be randomly assigned to group, or individual (n=90) physiotherapy. In both conditions participants will be given a psycho-educational treatment and common physiotherapy protocol. The treatment will include discussions on theoretical issues i.e. back-care, pain- management and fear avoidance beliefs. Group-treated patients will receive 6 weekly meetings. Those being treated individually will receive individual designed program which is commonly used in physiotherapy.

The treatment stresses supportive counseling and patient education. The treatment is based on the Carl Rogers humanistic approach which places the patient's here-and-now in the center and aims to solve the patient's current problem.

All of the therapists in this study will be qualified physiotherapists and have been trained in physiotherapy group leading.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic low back pain
  • > 18 years
  • not classified as derangement with centralization
  • ability to participate in exercise group
  • ability to speak and write in Hebrew

Exclusion Criteria:

  • pregnancy
  • S/P operation in the last year
  • any health problem which limits the ability to exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640132

Contacts
Contact: Ofra Netzer, MA +97246542768 nezer_o@mac.org.il
Contact: Daniel Deutscher, PHD 97248141862 deutsch_d@mac.org.il

Locations
Israel
Physical Therapy Center, Maccabi Healthcare Services Recruiting
Migdal Haemek, Israel
Contact: Ofra Mrs. Netzer, MA     +97246542768     nezer_o@mac.org.il    
Mccabi Health Organization Recruiting
The study takes place in 8 cities in Israel, Israel
Contact: Ofra Netzer     97246542768     nezer_o@mac.org.il    
Principal Investigator: Marina Sigal, MD            
Sponsors and Collaborators
Assuta Hospital Systems
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01640132     History of Changes
Other Study ID Numbers: 12/2012
Study First Received: June 3, 2012
Last Updated: April 14, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Assuta Hospital Systems:
low back pain
physiotherapy
group therapy
 fear avoidance beliefs
exercise
back school

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013