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.
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.
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:
- before starting the therapy cycle,
- 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).
- Conditions
- Physical Therapy, Low Back Pain, Chronic Pain
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analogue Scale (0-10)
Measured: 4 weeks
Secondary outcomes (2)
Disability
Oswestry Disability Index
Measured: 4 weeks
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.
- First posted21 Feb 2021
- Study start1 Sep 2019
- Primary completion1 Mar 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical TherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Truszczynska Baszak, Józef Piłsudski University of Physical Education
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 31130170Arab 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 30100288Barr 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of GRAVITY System Therapy on Chronic Low Back Pain in Disc Disease
- ClinicalTrials.gov ID
- NCT04765293
- Acronym / sponsor ID
- GRAVITY / Research Group no 4
- Conditions
- Physical Therapy, Low Back Pain, Chronic Pain
- Keywords
- gravity system, strengthening exercises, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 21 Feb 2021 (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.
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.
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:
- before starting the therapy cycle,
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gravity group | Experimental | Other: Physical TherapyGRAVITY® 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. |
| Control group | Active comparator | Other: Physical TherapyControl 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- other spinal dysfunctions
- history of spinal surgery,
- physiotherapy attendance before the start of the study
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 |
|---|---|---|
| Physical TherapyAlso: Gravity vs standard physical therapyPhysical Therapy Gravity strengthening exercises vs standard physical therapy | Other | Control group, Gravity group |
Primary outcome
Pain intensity
Time frame: 4 weeks
Visual Analogue Scale (0-10)
2 secondary outcomes
Disability
Time frame: 4 weeks
Abdominal muscle strength
Time frame: 4 weeks
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 21 Feb 2021.
- Background: PubMed 31130170B 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.
- Background: PubMed 30100288Arab 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.
- Background: PubMed 15905663Barr 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.
- Individual participant dataSharing planned: Undecided. row results data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.