NCT01631344

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. 1.Study objectives:
  2. 2.Study hypotheses:
  3. 3.Pain reduction.
  4. 4.Less disability - improvement in daily activities.
  5. 5.Better feeling of health and well-being.
  6. 6.Increased and better compliance to daily sport activities.
  7. 7.BMI reduction.
  8. 8.Reduction of cigarette smoking.
  9. 9.Reduction of usage of anti-analgesics and anti-inflammatory medications.
  10. 10.Reduction in number of visits to Physical Therapy clinics due to low back pain.
  11. 11.Methods:
  12. 12.Conventional Physical Therapy.
  13. 13.Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

6.4 years

First QC Date

June 7, 2012

Last Update Submit

January 9, 2019

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years

    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

    3 months, 1, 2 and 5 years

Study Arms (2)

Physical Therapy

NO INTERVENTION

Conventional Physical Therapy

Daily physical activity consultation, Using Stage of change

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

Interventions

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

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

Daily physical activity consultation, Using Stage of change

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Rheumatoid disease
  • Tumors
  • Fibromyalgia
  • Back surgery
  • Road / work accidents
  • Non Hebrew speaking
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi Healthcare Services Clinics

Tel Aviv, Israel

Location

Related Publications (3)

  • 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.

    PMID: 29643158DERIVED

  • 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.

    PMID: 29587572DERIVED

  • 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.

    PMID: 28142364DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yair Shapiro, MD.

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 29, 2012

Study Start

February 1, 2011

Primary Completion

July 1, 2017

Study Completion

January 8, 2019

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

IL(1)