NCT04765293

Brief Summary

The aim of the study was to examine the effect of GRAVITY system therapy on chronic disc-related pain in lumbar spine. Investigators made a hypothesis that patients who regularly perform core strengthening exercises based on gravity system will decrease pain and disability, and increase muscle strength in higher extent comparing to control group, that receive passive physical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 17, 2021

Last Update Submit

February 19, 2021

Conditions

Physical TherapyLow Back PainChronic Pain

Keywords

gravity systemstrengthening exercisesdisability

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Visual Analogue Scale (0-10)

    4 weeks

Secondary Outcomes (2)

  • Disability

    4 weeks

  • Abdominal muscle strength

    4 weeks

Study Arms (2)

Gravity group

EXPERIMENTAL

GRAVITY® system exercise is conducted on a machine. The tasks were non-weight bearing, and the only external load was the body mass of the trainee. The degree of unloading (the level of exercise) was chosen depending on the patient's body mass, their current health and the difficulty of the exercise. The machine allowed for exercising any chosen muscle group at chosen setting of the bench, platform and ropes. GRAVITY® system exercise aimed at general posture improvement and at strengthening the desired movement path, along with strengthening the deep spinal and abdominal muscles. GRAVITY therapy group had therapy twice a week for 4 weeks for 40 minutes that made 2x40 minx 4 weeks=320 minutes.

Other: Physical Therapy

Control group

ACTIVE COMPARATOR

Control group had standard, two weeks ambulant every day physical therapy sessions ( laser therapy, cryotherapy, magnetotherpy, TENS and interference currents), 5 times a week 30 min, that is 10 sessions 30 min x10=300 min.

Other: Physical Therapy

Interventions

Physical TherapyOTHER

Physical Therapy Gravity strengthening exercises vs standard physical therapy

Also known as: Gravity vs standard physical therapy
Control groupGravity group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with chronic, local low back pain
  • diagnosed with lumbar spinal disc disease confirmed with medical examination and anamnesis by a physiotherapist/ neurosurgeon; current MRI scan,
  • no history of spinal surgery,
  • no earlier physiotherapy

You may not qualify if:

  • other spinal dysfunctions
  • history of spinal surgery,
  • physiotherapy attendance before the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizjokoncept

Warsaw, Masovian Voivodeship, 02-305, Poland

Location

Related Publications (3)

  • B Amorim A, Simic M, Pappas E, Zadro JR, Carrillo E, Ordonana JR, Ferreira PH. Is occupational or leisure physical activity associated with low back pain? Insights from a cross-sectional study of 1059 participants. Braz J Phys Ther. 2019 May-Jun;23(3):257-265. doi: 10.1016/j.bjpt.2018.06.004. Epub 2018 Jun 28.

    PMID: 31130170BACKGROUND

  • Arab AM, Shanbehzadeh S, Rasouli O, Amiri M, Ehsani F. Automatic activity of deep and superficial abdominal muscles during stable and unstable sitting positions in individuals with chronic low back pain. J Bodyw Mov Ther. 2018 Jul;22(3):627-631. doi: 10.1016/j.jbmt.2017.10.009. Epub 2017 Oct 25.

    PMID: 30100288BACKGROUND

  • Barr KP, Griggs M, Cadby T. Lumbar stabilization: core concepts and current literature, Part 1. Am J Phys Med Rehabil. 2005 Jun;84(6):473-80. doi: 10.1097/01.phm.0000163709.70471.42.

    PMID: 15905663BACKGROUND

MeSH Terms

Conditions

Low Back PainChronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor was blinded concerning participants therapy model and results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

September 1, 2019

Primary Completion

March 1, 2020

Study Completion

June 1, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

PL(1)