OsteopeniaNCT04854629
Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.
A study testing Spinomed active in people with Osteopenia and Kyphosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Osteoporotic vertebral fractures often lead to postural changes, chronic spinal pain conditions and limited functionality. Orthoses that straighten the spine have been shown in studies to have a positive effect on pain, posture and the functional state of patients with a fresh vertebral fracture. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteopenia, Kyphosis
- What is being tested?
- Spinomed active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 7 Apr 2021to 15 Jan 2022
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Living independently in the community
- ≥ 1 low-traumatic vertebral fracture ≥ 3 months ago
- Chronic back pain according to the national guideline for low back pain
- Mean back pain intensity NPS ≥ 1 (1-10 scale)
- Hyperkyphosis, kyphosis angle according to Debrunner >40°
- Intact skin or adequate wound coverage in the area of the contact surface of the orthosis
Who cannot join
- Secondary osteoporosis (as determined by study physician)
- Expected change in overall pain therapy during the study period
- Structurally fixed kyphosis, lack of extension ability of the thoracic spine
- Kyphoplasty, vertebroplasty
- Use of back orthoses during the last 6 months
- Depression
Show all 10Show fewer
- Dementia, cognitive impairment (Mini Mental Test < 25)
- Fresh neurological deficits; incontinence > grade 1
- Body dimensions that do not allow for adjustment of the back orthosis
- Absence during baseline and follow-up assessments
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, 91052
About this study
Official title: Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.
Osteoporotic vertebral fractures often lead to postural changes, chronic spinal pain conditions and limited functionality. Orthoses that straighten the spine have been shown in studies to have a positive effect on pain, posture and the functional state of patients with a fresh vertebral fracture.
The planned study investigates the effect of the orthosis "Spinomed active" in patients aged ≥ 65 years with at least one non-acute osteoporotic vertebral fracture (at least 3 months ago) and chronic back pain.
- Conditions
- Osteopenia, Kyphosis
- Being tested
- Spinomed active
- Medical subject headings
- Bone Diseases, Metabolic, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinomed activeOther
Wearing of the orthosis 2-3 h/twice a day for 16 weeks Supplementation of a maximum of 1000 mg/d calcium and 800 IE/d vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Spinomed active orthosis | Experimental | Wearing the orthosis for 16 weeks Receives: Other: Spinomed active |
| Control group | No intervention | No intervention: non spinomed active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain
Change in back pain (mean intensity over 4 weeks on the "numeric pain scale (NPS) "0-10").
Measured: At baseline and after 16 weeks (i.e. over 16 weeks)
Secondary outcomes (6)
Trunk strength/performance
Changes of maximum dynamic trunk strength (index of trunk extension/flexion/lateral flexion) as determined by a dynamic testing device
Measured: At baseline and after 16 weeks (i.e. over 16 weeks)
Kyphosis angle
Changes of kyphosis angle as determined by angle measurement
Measured: At baseline and after 16 weeks (i.e. over 16 weeks)
Functional capacity
Changes in Chair-Rise-Test
Measured: At baseline and after 16 weeks (i.e. over 16 weeks)
Pulmonary function
Changes in vital capacity as determined by a pulmonary function monitor
Measured: At baseline and after 16 weeks (i.e. over 16 weeks)
Everyday life skills
Changes of everyday life skills as determined by a questionnaire (late-life function and disability instrument)
Measured: At baseline and after 16 weeks (i.e. over 16 weeks)
Balance capacity
Changes in Body Sway as determined by a balance sensor device
Measured: At baseline and after 16 weeks (i.e. over 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start7 Apr 2021
- Primary completion15 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two study groups in parallel: (1) Spinomed active orthosis or 16 weeks (2) non spinomed active orthosis control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- medi GmbH & Co. KG, Bayreuth, Germany
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kemmler, PhD, Study chair, Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854629
- Sponsor's protocol ID
- Orthosis Spinomed active
- Status last verified
- Jan 2022
- First submitted
- 13 Apr 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available on request from the corresponding researcher (SW)
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.
- ClinicalTrials.gov ID
- NCT04854629
- Acronym / sponsor ID
- Orthosis Spinomed active
- Conditions
- Osteopenia, Kyphosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- medi GmbH & Co. KG, Bayreuth, Germany
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 22 Apr 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.
Osteoporotic vertebral fractures often lead to postural changes, chronic spinal pain conditions and limited functionality. Orthoses that straighten the spine have been shown in studies to have a positive effect on pain, posture and the functional state of patients with a fresh vertebral fracture.
The planned study investigates the effect of the orthosis "Spinomed active" in patients aged ≥ 65 years with at least one non-acute osteoporotic vertebral fracture (at least 3 months ago) and chronic back pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two study groups in parallel: (1) Spinomed active orthosis or 16 weeks (2) non spinomed active orthosis control
| Arm | Type | Receives |
|---|---|---|
| Spinomed active orthosis | Experimental | Other: Spinomed activeWearing the orthosis for 16 weeks |
| Control group | No intervention | –No intervention: non spinomed active control |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Living independently in the community
- ≥ 1 low-traumatic vertebral fracture ≥ 3 months ago
- Chronic back pain according to the national guideline for low back pain
- Mean back pain intensity NPS ≥ 1 (1-10 scale)
- Hyperkyphosis, kyphosis angle according to Debrunner >40°
Key exclusion criteria (10 listed)
- Secondary osteoporosis (as determined by study physician)
- Expected change in overall pain therapy during the study period
- Structurally fixed kyphosis, lack of extension ability of the thoracic spine
- Kyphoplasty, vertebroplasty
- Use of back orthoses during the last 6 months
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 |
|---|---|---|
| Spinomed activeWearing of the orthosis 2-3 h/twice a day for 16 weeks Supplementation of a maximum of 1000 mg/d calcium and 800 IE/d vitamin D | Other | Spinomed active orthosis |
Primary outcome
Back pain
Time frame: At baseline and after 16 weeks (i.e. over 16 weeks)
Change in back pain (mean intensity over 4 weeks on the "numeric pain scale (NPS) "0-10").
6 secondary outcomes
Trunk strength/performance
Time frame: At baseline and after 16 weeks (i.e. over 16 weeks)
Kyphosis angle
Time frame: At baseline and after 16 weeks (i.e. over 16 weeks)
Functional capacity
Time frame: At baseline and after 16 weeks (i.e. over 16 weeks)
Pulmonary function
Time frame: At baseline and after 16 weeks (i.e. over 16 weeks)
Everyday life skills
Time frame: At baseline and after 16 weeks (i.e. over 16 weeks)
Balance capacity
Time frame: At baseline and after 16 weeks (i.e. over 16 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 19 Jan 2022.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available on request from the corresponding researcher (SW)
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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.
Wolfgang Kemmler, PhD study chair
Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinomed active in people with Osteopenia and Kyphosis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 6 inclusion and 10 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 19 Jan 2022. 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 Germany. 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?
Back pain (time frame: At baseline and after 16 weeks (i.e. over 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.