Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT04854629
• Collaborator: medi GmbH & Co. KG, Bayreuth, Germany (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia; Kyphosis	Other: Spinomed active	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial with two study groups in parallel: (1) Spinomed active orthosis or 16 weeks (2) non spinomed active orthosis controlRandomized controlled trial with two study groups in parallel: (1) Spinomed active orthosis or 16 weeks (2) non spinomed active orthosis control
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes assessor were unaware of participant status (i.e. spinomed active or control) and were not allowed to ask correspondingly
• Primary Purpose: Other
• Official Title: Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Osteoporotic Vertebral Bone Fracture and Hyperkyphosis.
• Actual Study Start Date: Apr 7, 2021
• Actual Primary Completion Date: Dec 15, 2021
• Actual Study Completion Date: Jan 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spinomed active orthosis Wearing the orthosis for 16 weeks	Other: Spinomed active; 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
No Intervention: Control group No intervention: non spinomed active control

Outcome Measures

Primary Outcome Measures

1. Back pain [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").

Secondary Outcome Measures

1. Trunk strength/performance [At baseline and after 16 weeks (i.e. over 16 weeks)]

   Changes of maximum dynamic trunk strength (index of trunk extension/flexion/lateral flexion) as determined by a dynamic testing device

2. Kyphosis angle [At baseline and after 16 weeks (i.e. over 16 weeks)]

   Changes of kyphosis angle as determined by angle measurement

3. Functional capacity [At baseline and after 16 weeks (i.e. over 16 weeks)]

   Changes in Chair-Rise-Test

4. Pulmonary function [At baseline and after 16 weeks (i.e. over 16 weeks)]

   Changes in vital capacity as determined by a pulmonary function monitor

5. Everyday life skills [At baseline and after 16 weeks (i.e. over 16 weeks)]

   Changes of everyday life skills as determined by a questionnaire (late-life function and disability instrument)

6. Balance capacity [At baseline and after 16 weeks (i.e. over 16 weeks)]

   Changes in Body Sway as determined by a balance sensor device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Medical Physics University of Erlangen-Nurnberg	Erlangen		Germany	91052

Sponsors and Collaborators

• University of Erlangen-Nürnberg Medical School
• medi GmbH & Co. KG, Bayreuth, Germany

Investigators

• Study Chair: Wolfgang Kemmler, PhD, Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT04854629
• Other Study ID Numbers: Orthosis Spinomed active
• First Posted: Apr 22, 2021
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bone Diseases, Metabolic; Kyphosis; Back Pain

Study Results

No Results Posted as of Jan 19, 2022