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NCT Number: NCT01631344

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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maccabi Healthcare Services Clinics

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Daily physical activity consultation, Using the "Stage of change" model

Other

Consultation of daily physical activity is provided, including selection of up to four pain relief exercises

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assuta Hospital Systems

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2017
Study completion
2019
First posted
Jun 29, 2012
Registry last updated
Jan 10, 2019

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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