- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04284982
Periodized Resistance Training for Persistent Non-specific Low Back Pain
February 24, 2020 updated by: Norwegian University of Science and Technology
Periodized Resistance Training for Persistent Non-specific Low Back Pain: A Mixed Methods Feasibility Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Trondheim, Norway
- Dept of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heavy resistance training program
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Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low back pain intensity on 0-10 Numerical Pain Rating Scale
Time Frame: 8 weeks
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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
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8 weeks
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Low back pain intensity on 0-10 Numerical Pain Rating Scale
Time Frame: 16 weeks
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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
|
16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jorunn Helbostad, prof, Dept Neuromedicine and Movement Science, Fac MH, NTNU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2017
Primary Completion (Actual)
December 21, 2017
Study Completion (Actual)
December 21, 2017
Study Registration Dates
First Submitted
February 24, 2020
First Submitted That Met QC Criteria
February 24, 2020
First Posted (Actual)
February 26, 2020
Study Record Updates
Last Update Posted (Actual)
February 26, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Collected data and research protocol are available from the corresponding author on reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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