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Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain

This study is currently recruiting participants.
Verified January 2012 by Assuta Hospital Systems
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01631344
First received: June 7, 2012
Last updated: April 14, 2013
Last verified: January 2012
History of Changes
  Purpose

Background:

Low back pain is the leading cause of disability, affecting the quality of life and work productivity.

It is the most common reason for seek medical help and advice. Low back pain creates huge economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically defined with no preferred medical treatment

  1. Study objectives:

    To prove that consulting using the "Stage of change" model for daily physical activity will lead to long term improvement of pain, disability and well-being parameters of those suffering from chronic low back pain, people age 25-55, when compared to conventional Physical Therapy.

  2. Study hypotheses:

    The intervention groups vs. Physical Therapy group will demonstrate that the following parameters will improve after: 3 months, one, two and five years.

    1. Pain reduction.
    2. Less disability - improvement in daily activities.
    3. Better feeling of health and well-being.
    4. Increased and better compliance to daily sport activities.
    5. BMI reduction.
    6. Reduction of cigarette smoking.
    7. Reduction of usage of anti-analgesics and anti-inflammatory medications.
    8. Reduction in number of visits to Physical Therapy clinics due to low back pain.
  3. Methods:

The present Randomized intervention study that will include 220 healthy individuals, males and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or without radiation to the legs that were referred to Maccabi Healthcare Services Physical Therapy clinics in the Sharon district in Israel.

These individuals will be randomized to one of the following two groups:

  1. Conventional Physical Therapy.
  2. Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.

Non-dependent observer will follow-up on the outcome parameters via phone calls and filling the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5 years.


Condition Intervention
Low Back Pain
 Other: Daily physical activity consultation, Using the "Stage of change" model

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention Study to Examine the Effectiveness of Lifestyle Counseling Using the "Stage of Change" Model Versus Conventional Physical Therapy on Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years [ Time Frame: 3 months, 1, 2 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years [ Time Frame: 3 months, 1, 2 and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: February 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Physical Therapy
Conventional Physical Therapy
Experimental: Daily physical activity consultation, Using Stage of change Other: Daily physical activity consultation, Using the "Stage of change" model
Consultation of daily physical activity is provided, including selection of up to four pain relief exercises

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women
  • Age 25-55 years old
  • Chronic / recurrent low back pain (over 3 months)
  • With or without radiation

Exclusion Criteria:

  • Rheumatoid disease
  • Tumors
  • Fibromyalgia
  • Back surgery
  • Road / work accidents
  • Non Hebrew speaking
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631344

Contacts
Contact: Noa Ben Ami, Msc. P.T. +972 54 4989778 djba@bezeqint.net

Locations
Israel
Maccabi Healthcare Services Clinics Recruiting
Tel Aviv, Israel
Contact: Noa Ben Ami, Msc. P.T.     +972 54 4989778     djba@bezeqint.net    
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Yair Shapiro, MD. Maccabi Healthcare Services, Israel
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01631344     History of Changes
Other Study ID Numbers: 2008036
Study First Received: June 7, 2012
Last Updated: April 14, 2013
Health Authority: Israel: Ethics Commission

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 22, 2013