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

Assuta Hospital Systems

Status: Completed

Conditions: Low Back Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01631344

2008036

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Physical Therapy

No Intervention group

Description:

Conventional Physical Therapy

Daily physical activity consultation, Using Stage of change

Experimental group

Treatment:

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