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Physical TherapyGRAVITYNCT04765293

GRAVITY System Therapy on Chronic Low Back Pain

A study testing Physical Therapy in people with Physical Therapy and Low Back Pain, run by Józef Piłsudski University of Physical Education at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Physical Therapy, Low Back Pain, Chronic Pain
What is being tested?
Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePoland
Study dates
1 Sep 2019to 1 Jun 2020
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 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Fizjokoncept

    Warsaw, Masovian Voivodeship, 02-305

Other trials in Poland

About this study

Official title: The Effect of GRAVITY System Therapy on Chronic Low Back Pain in Disc Disease

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.

Read the detailed description

GRAVITY therapy group had therapy twice a week for 4 weeks for 40 minutes that made 2x40 minx 4 weeks=320 minutes.

Clinical control group had standard, two weeks ambulant, every day, physical therapy sessions, 5 times a week 30 min, that is 10 sessions 30 min x10=300 min. So the total amount of treatment was comparable.

All participants in both groups completed the study. Investigators used the Oswestry Disability Index (ODI) to determine the disability level of patient with low back pain (Shah et al, 2016), and VAS scale (visual analogue scale) (0-10) to measure pain intensity.

The next stage of examination was the lumbopelvic complex stability test. The test comprised of several activities which had to be performed without lifting the lumbar region. The more difficult activity a patient was able to perform, the higher was assessed their muscle strength.

All the patients were examined twice:

  1. before starting the therapy cycle,
  2. and after the therapy. They were informed about the aim of the study, the study course and the possible risks. The participation in the study was voluntary and anonymous. The patients signed informed consent to participate in the study. The next step was the lumbopelvic complex stability test. Patients took it in lying position. The therapist placed their hand under the patient's lumbar region, with the patient's spinous processes resting on second do fifth metacarpal heads. Then, the therapist instructed the patient on the type of movement the patient was supposed to perform. The patient's task was to perform the task without lifting the lumbar region off the therapists' fingers. If the task was performed correctly, the next level task ensued. If the patient lifted their lumbar region, it meant that they did not have enough muscle strength for that level. The test was to be performed without pain, and if the patient felt pain, the test was discontinued and the patient was assigned muscle strength from the level without pain syndromes. Each correctly performed task translated into a given level of muscle strength.

Level 0.3 - lying on the back with the limbs flexed at the hips and knees. The patient drew the knee to the chest, then returned to the starting position. Level 0.4 - lying on the back, the patient held flexed leg with their arms at their chest, and then drew the other leg. Level 0.5 - the same exercise as in position 0.4, yet without stabilizing the leg with the arms. Level 1a - one leg flexed at the hip and the knee, the other leg was lying extended and then it was raised upwards, extended. Then, the patient swapped legs and repeated the task. Level 1b - patient position as in 1a, yet the extended leg was brought up to the flexed leg. Then the patient swapped legs and repeated the exercise. Level 2 - one leg was flexed at 90° at the hip and at the knee, the other leg was extended. The patient extended the flexed leg, sliding the heel on the ground. After the knee was fully extended, the leg returned to the starting position. Then the patient swapped legs. Level 3 - the patient flexed first one leg and then the other leg to 90°, and then extended first one leg and then the other leg and slid them out on the ground. After the knee was fully extended, the limb returned to the starting position. Level 4 - both legs were extended on the ground, then the patient flexed both limbs sliding their heel on the ground, and then lifted then, flexing the leg at the hip to 90° and returned to starting position. Level 5 - starting position as in level 4, the patient flexed legs at the hip and the knee and drew them to the chest, then the patient extended both legs simultaneously at the hip and the knee, thus returning to the starting position.

Therapy 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.

The training sessions started with manometer exercise - the manometer was placed under the lumbar region of the spine. As the patient exhaled and tensed their abdominal muscles, manometer membrane was pumped to 40 mmHg. This provided non-invasive biofeedback, making the patients aware if their deep smooth muscles maintained the desired tension. The patients were to conduct all exercises (knee bends on a sloping bench, lower limb abduction, upper and lower body exercise) while simultaneously maintaining abdominal muscles tension on the level.

Then, the patients conducted their training designed accordingly to their individual needs. The most common exercise set was the following: moving their arms from behind the head in the lying on the back position (2x12 repetitions), abductions to 90° in the lying position (3 sets of 10 repetitions for both the right and the left side), adduction of both arms in the sitting position facing the machine (2x12), pulling the bench (2x12), abdominal oblique muscle tension (2x10) (fig. 2), rotating the trunk in sitting position (2x10 on the right and on the left sides), plank (2x30s), knees to chest (2x10), heels-up on the platform (3x15 left leg, right leg, both feet), steps forward (2x10 right leg and left leg). While exercising, the patients were to maintain the right body posture actively by tensing their abdominal muscles. Each exercise could be performed in several variations, such as: both limbs working out simultaneously, or single limb workout, or increasing the level through making the exercise easier or more difficult to perform. At the end of each training session patients stretched individual muscle groups (e.g. posterior thigh muscles, quadriceps femoris muscle, and triceps surae muscle) or they used rollers.

In the clinical control group, the patients had physical therapy such as: laser therapy, cryotherapy, magnetotherpy, interference currents. They had therapy every day for the period of two weeks.

Both groups had different blinded clinicians supervising therapy. Another specialist collected and analysed the treatment results.

Patients from both groups did not received any other simultaneous treatments (e.g., pharmacological or psychological).

Being tested
Physical Therapy
Keywords
gravity system, strengthening exercises, disability
Medical subject headings
Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical TherapyOther

    Also called Gravity vs standard physical therapy

    Physical Therapy Gravity strengthening exercises vs standard physical therapy

Study groups in NCT04765293
Study groupRoleWhat they receive
Gravity groupExperimentalGRAVITY® 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.
Receives: Other: Physical Therapy
Control groupActive comparatorControl 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.
Receives: Other: Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity

    Visual Analogue Scale (0-10)

    Measured: 4 weeks

Secondary outcomes (2)
  1. Disability

    Oswestry Disability Index

    Measured: 4 weeks

  2. Abdominal muscle strength

    lumbopelvic complex stability test by Sahrmann

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start1 Sep 2019
  3. Primary completion1 Mar 2020
  4. Study completion1 Jun 2020

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04765293
Sponsor's protocol ID
Research Group no 4
Other IDs
SN 4
Acronym
GRAVITY
Status last verified
Feb 2021
First submitted
17 Feb 2021
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: row results data

Publications

  • 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.

    PubMed 31130170
  • 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.

    PubMed 30100288
  • 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.

    PubMed 15905663

Questions about this trial

What is this clinical trial studying?

A study testing Physical Therapy in people with Physical Therapy and Low Back Pain, run by Józef Piłsudski University of Physical Education at 1 site in Poland.

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 4 inclusion and 3 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 21 Feb 2021. 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 Poland. 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?

Pain intensity (time frame: 4 weeks). 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 NCT04765293, which also lists 3 linked publications.

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 21 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.

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