NCT04284982

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2017

Shorter than P25 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

September 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 24, 2020

Last Update Submit

February 24, 2020

Conditions

Keywords

Exercise therapyResistance training

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    16 weeks

Study Arms (1)

Heavy resistance training program

EXPERIMENTAL
Behavioral: 16-week supervised heavy resistance training program with weekly undulating periodization

Interventions

Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks

Heavy resistance training program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trondheim, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jorunn Helbostad, prof

    Dept Neuromedicine and Movement Science, Fac MH, NTNU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

September 4, 2017

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Collected data and research protocol are available from the corresponding author on reasonable request.

Locations