Clinical trial NCT01631344: Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 220
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years
timeFrame: 3 months, 1, 2 and 5 years
Secondary outcomes:
measure: Change from baseline of Pain using the Numerical pain scale at 3 months, 1, 2 and 5 years
timeFrame: 3 months, 1, 2 and 5 years
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Maccabi Healthcare Services Clinics
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Yair Shapiro, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canaway A, Pincus T, Underwood M, Shapiro Y, Chodick G, Ben-Ami N. Is an enhanced behaviour change intervention cost-effective compared with physiotherapy for patients with chronic low back pain? Results from a multicentre trial in Israel. BMJ Open. 2018 Apr 10;8(4):e019928. doi: 10.1136/bmjopen-2017-019928.
citation: Ben-Ami N, Shapiro Y, Pincus T. Outcomes in Distressed Patients With Chronic Low Back Pain: Subgroup Analysis of a Clinical Trial. J Orthop Sports Phys Ther. 2018 Jun;48(6):491-495. doi: 10.2519/jospt.2018.7670. Epub 2018 Mar 27.
citation: Ben-Ami N, Chodick G, Mirovsky Y, Pincus T, Shapiro Y. Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial. J Orthop Sports Phys Ther. 2017 Feb;47(2):57-66. doi: 10.2519/jospt.2017.7057.