Low Back PainNCT04284982
Periodized Resistance Training for Persistent Non-specific Low Back Pain
A study testing 16-week supervised heavy resistance training program with weekly undulating periodization in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- 16-week supervised heavy resistance training program with weekly undulating periodization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 4 Sep 2017to 21 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
Trondheim
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- 16-week supervised heavy resistance training program with weekly undulating periodization
- Keywords
- Exercise therapy, Resistance training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-week supervised heavy resistance training program with weekly undulating periodizationBehavioural
Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Heavy resistance training program | Experimental | Not described Receives: Behavioral: 16-week supervised heavy resistance training program with weekly undulating periodization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start4 Sep 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorunn Helbostad, prof, Study director, Dept Neuromedicine and Movement Science, Fac MH, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284982
- Sponsor's protocol ID
- 2017/905
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collected data and research protocol are available from the corresponding author on reasonable request.
Publications
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.
PubMed 32411374
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodized Resistance Training for Persistent Non-specific Low Back Pain: A Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT04284982
- Acronym / sponsor ID
- 2017/905
- Conditions
- Low Back Pain
- Keywords
- Exercise therapy, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heavy resistance training program | Experimental | Behavioral: 16-week supervised heavy resistance training program with weekly undulating periodization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16-week supervised heavy resistance training program with weekly undulating periodizationParticipants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks | Behavioural | Heavy resistance training program |
Primary outcome
Low back pain intensity on 0-10 Numerical Pain Rating Scale
Time frame: 8 weeks
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
Time frame: 16 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 32411374Tjosvoll 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.
- Individual participant dataSharing planned: Yes. Collected data and research protocol are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorunn Helbostad, prof study director
Dept Neuromedicine and Movement Science, Fac MH, NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16-week supervised heavy resistance training program with weekly undulating periodization in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain intensity on 0-10 Numerical Pain Rating Scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04284982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020; AzTrials last refreshed its copy on 31 Oct 2026.