Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group

NCT03263585 | Completed

• 1 other identifier: dnr 2011/142-31/3
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Back pain and osteoporosis with vertebral fractures are common conditions in elderly women and significantly affect their quality of life. A common complication of osteoporosis are vertebral fractures. Treatment with bone-specific drugs does often not help the pain condition caused by the vertebral fractures even when the progress of the disease has decreased. Vertebral fractures often result in deformation of the spine and poorer quality of life of the individual. The spinal kyphosis also affects the lung function and the effect of the kyphosis itself is severe. Alternative treatments of back pain may lead to reduced drug demand for pain. Physical activity is one of the most important factors that regulates bone mass and can also affect balance and fall risk positively. The back orthosis that we intend to use in the treatment study has been shown in some previous scientific studies to strengthen the muscles in the back and also decrease the pain. Purpose: The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating functional orthosis versus treatment with a group of physiotherapeutic tools and a control group for a six-month treatment period and follow-up after 12 months from the start of study. The aim was also to study elderly women with osteoporosis and back pain in a follow-up study of a cohort of women at high risk of osteoporotic fractures, with focus on back pain, functional capacity and quality of life. The aim was to study the effect of treatment with activating functional orthosis versus physiotherapeutic treatment in a group and a control group without treatment. The main outcomes will be the experienced perceived back pain and back extensor strength. Additional outcomes will be quality of life, balance, lung function and kyphosis. Biochemical markers for pain will be measured in the RCT (Randomized Controlled Trial). Significance: Evaluation of alternative treatment methods such as exercise by a physiotherapist and treatment with a functional orthosis will give new additional treatment options for our patients. An activating functional orthosis could reduce the use of analgesics and increase the quality of life of the affected women.

Conditions

Osteoporosis; Vertebral Fracture; Back Pain; Elderly Women

Keywords

Osteoporosis; Vertebral Fracture; Back Pain; Spinal orthosis; Elderly women

Outcome Measures

Primary Outcomes (1)

• Back pain

  Measured with Visual Analogue Scale

  Baseline and six months

Secondary Outcomes (17)

• Back muscle extensor strength

  Baseline and six months

• Borg CR-10

  Baseline and six months

• Kyphosis

  Baseline and six months

• Substance P

  Baseline and six months

• CGRP Calcitonin Gene Related Peptide

  Baseline and six months

Study Arms (3)

Spinal orthosis group

ACTIVE COMPARATOR

Women wearing the spinal orthosis Spinomed for 6 months at least 2 hours a day.

Device: Spinal orthosis Spinomed

Equipment training group

ACTIVE COMPARATOR

Women training once a week in an equipment training group led by a physiotherapist for six months.

Other: Equipment training

Control

NO INTERVENTION

Women in the control group get no intervention for six months.

Interventions

Spinal orthosis Spinomed DEVICE

Spinal orthosis group

Equipment training OTHER

Equipment training group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman aged ≥ 60 years
• Osteoporosis according to DXA (Dual X-Ray Absorptiometry) hip (femoral neck or total hip) or lumbar spine.
• Back pain.

You may not qualify if:

• Diagnosed symptomatic spinal stenosis
• Difficulty to participate in the activities included in the study due to health problems.
• Difficulty to participate in equipment training group.
• Inability to be able to complete wearing the spinal orthosis.
• Language difficulties
• Cognitive difficulties
• Visual problems

Sponsors & Collaborators

• Helena Salminen: lead
• Medi GmbH & Co.KG: collaborator

Study Sites (2)

Rehab City

Stockholm, 11361, Sweden

Location

Liljeholmen Academic Health Centre

Stockholm, 11763, Sweden

Location

Related Publications (21)

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  PMID: 16391579 BACKGROUND

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• Kaijser Alin C, Uzunel E, Grahn Kronhed AC, Alinaghizadeh H, Salminen H. Effect of treatment on back pain and back extensor strength with a spinal orthosis in older women with osteoporosis: a randomized controlled trial. Arch Osteoporos. 2019 Jan 9;14(1):5. doi: 10.1007/s11657-018-0555-0.

  PMID: 30623268 DERIVED

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures; Back Pain

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eeva Helena S Salminen, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: August 28, 2017
• Study Start: May 3, 2012
• Primary Completion: November 22, 2012
• Study Completion: December 22, 2014
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)