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Periodized Resistance Training for Persistent Non-specific Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
16-week supervised heavy resistance training program with weekly undulating periodization
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Exercise therapy, Resistance training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • persistent non-specific low back pain with a duration >3 months
  • average low back pain intensity last two weeks >= 4 on numerical pain rating scale (0-10 scale)
  • no experience with heavy resistance training.

Exclusion Criteria:

  • previous surgery of the low back
  • radiculopathy
  • structural spinal changes and/or specific spinal conditions that limit function (spinal stenosis, ankylosing spondylitis, spondylolisthesis/spondylolysis, protrusion, structural scoliosis)
  • autoimmune and systemic inflammatory diseases
  • cardiovascular disease
  • neurological diseases
  • severe osteoporosis.

Sites / Locations

  • Dept of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heavy resistance training program

Arm Description

Outcomes

Primary Outcome Measures

Low back pain intensity on 0-10 Numerical Pain Rating Scale
From questionnaire: current pain, pain the last two weeks and pain the last four weeks, scale from 0-10 were 0 equals no pain and 10 equals the worst pain imaginable
Low back pain intensity on 0-10 Numerical Pain Rating Scale
From questionnaire: current pain, pain the last two weeks and pain the last four weeks, scale from 0-10 were 0 equals no pain and 10 equals the worst pain imaginable

Secondary Outcome Measures

Full Information

First Posted
February 24, 2020
Last Updated
February 24, 2020
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04284982
Brief Title
Periodized Resistance Training for Persistent Non-specific Low Back Pain
Official Title
Periodized Resistance Training for Persistent Non-specific Low Back Pain: A Mixed Methods Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study the feasibility is investigated of a 16-week supervised heavy resistance training program with weekly undulating periodization for individuals with persistent non-specific low-back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Exercise therapy, Resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heavy resistance training program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
16-week supervised heavy resistance training program with weekly undulating periodization
Intervention Description
Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks
Primary Outcome Measure Information:
Title
Low back pain intensity on 0-10 Numerical Pain Rating Scale
Description
From questionnaire: current pain, pain the last two weeks and pain the last four weeks, scale from 0-10 were 0 equals no pain and 10 equals the worst pain imaginable
Time Frame
8 weeks
Title
Low back pain intensity on 0-10 Numerical Pain Rating Scale
Description
From questionnaire: current pain, pain the last two weeks and pain the last four weeks, scale from 0-10 were 0 equals no pain and 10 equals the worst pain imaginable
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: persistent non-specific low back pain with a duration >3 months average low back pain intensity last two weeks >= 4 on numerical pain rating scale (0-10 scale) no experience with heavy resistance training. Exclusion Criteria: previous surgery of the low back radiculopathy structural spinal changes and/or specific spinal conditions that limit function (spinal stenosis, ankylosing spondylitis, spondylolisthesis/spondylolysis, protrusion, structural scoliosis) autoimmune and systemic inflammatory diseases cardiovascular disease neurological diseases severe osteoporosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorunn Helbostad, prof
Organizational Affiliation
Dept Neuromedicine and Movement Science, Fac MH, NTNU
Official's Role
Study Director
Facility Information:
Facility Name
Dept of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Collected data and research protocol are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
32411374
Citation
Tjosvoll SO, Mork PJ, Iversen VM, Rise MB, Fimland MS. Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study. BMC Sports Sci Med Rehabil. 2020 May 8;12:30. doi: 10.1186/s13102-020-00181-0. eCollection 2020.
Results Reference
derived

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Periodized Resistance Training for Persistent Non-specific Low Back Pain

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