Clinical trial NCT03263585: Treatment With a Spinal Orthosis Compared to Equipment Group Training and a Control Group
Official title: Identification and Treatment of Back Pain in Elderly Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Vertebral Fracture
Back Pain
Elderly Women
Keywords: Osteoporosis
Vertebral Fracture
Back Pain
Spinal orthosis
Elderly women
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Medi GmbH & Co.KG
First posted: 2017-08-28
Enrollment: 113
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: The aims: 1. Identification in a population-based cohort of elderly women the occurrence of vertebral fractures, back pain and their impact on quality of life.

2. To study the effect of treatment with a functional activating orthotic and physiotherapy in an equipment training group, both in comparison with a control group, on the perceived pain, back extensor muscle strength, quality of life, balance and incidence of falls, lung function and kyphosis.

3. Qualitative study of how participants experienced treatment and exercise in an activating orthotic. The investigators hypothesis was that a functional orthotic could be a complementary treatment method that could reduce the use of analgesics and increase the quality of life.

The purpose of the study was to evaluate the effect of treatment of back pain in elderly women with an activating spinal orthotic versus treatment with a physiotherapy equipment training group and a control group for a six-month treatment period and a follow-up six months after the end of treatment. The aim was also to identify the occurrence of vertebral fractures in a cohort of elderly women and to investigate their perceived quality of life.

Background: Osteoporosis is a condition in the skeleton that is characterized by reduced bone density and an increased risk of fractures \[1\]. Back pain and osteoporosis with vertebral fractures are common conditions in elderly women that significantly affect their quality of life. Vertebral fractures are the most common type of osteoporotic fracture \[2\]. Vertebral fractures are underdiagnosed and are a major problem. It is estimated that only one third of vertebral fractures are clinically detected \[3\]. The lifetime risk for a Swedish postmenopausal woman to get a clinically detected vertebral fracture is approximately 15% \[4\].

In the acute phase, a vertebral fracture is very painful and in the aftermath the vertebral fracture often leads to chronic back pain, increased kyphosis mainly located to the thoracic and lumbar spine, reduction in body height and impaired lung function. There exists a correlation between increased kyphosis and increased risk of falls \[5\]. Vertebral fractures can affect important daily activities and provide a lower health-related quality of life \[6-8\].

Treatment with bone-specific drugs does not relieve the back pain caused by the vertebral fractures despite improvement in the state of the disease. The kyphosis also affects lung function, and the effects of the kyphosis itself have previously been considered as very severe.

An important part in the treatment of patients with osteoporosis is physical therapy with an equipment training group. The goal is to maintain or increase mobility, strength and balance that can improve health-related quality of life and prevent fractures. Training of the back extensor muscles have shown to have a positive impact on health-related quality of life, reduce back pain, and training could also affect fear of falling positively \[5, 9\].

A German randomized controlled study from 2004 and one from 2011 has shown a positive effect of treatment with an activating spinal orthotic on body posture, back extensor muscular strength and quality of life in elderly women with osteoporosis and vertebral fractures \[10, 11\]. It was shown that wearing the spinal orthotic, back extensor muscle strength was increased through biofeedback. Training with the spinal orthotic also resulted in a significant decrease of the kyphosis, which also affected lung function and body height positively.

The investigators now intend, in a randomized controlled study, to compare training in an activating spinal orthotic with training in an equipment training group, led by a physiotherapist, to see if positive results can be obtained in reduced back pain, increased muscle strength in back extensor muscle, increasing mobility, and decreased kyphosis in the thoracic and lumbar spine. It can also lead to improved lung capacity, and further increased health-related quality of life. If the training method in the activating spinal orthotic appears to work, it would improve the possibilities to train and treat patients with osteoporosis, vertebral fractures and back pain.

Design A. A cross-sectional study of cohort elderly women regarding the occurrence of vertebral fractures and their impact on health related quality of life and back pain.

B. A randomized controlled study where the effect of treatment with an activating spinal orthotic is compared with training in an equipment training group led by a physiotherapist and with an untreated control group for a six-month treatment period and a follow-up six months after the end of the treatment period.

C. A qualitative study with interviews in focus groups were the participating women may describe their experiences of training in an activating spinal orthotic and how they experience health related quality of life during the treatment period.

Methods Cross-sectional study All 186 women who participated in the follow-up study of the Primos project, a population-based cohort study in Stockholm were invited to participate in the current study \[12-15\]. All these women have been re-examined clinically in a longitudinal follow-up study with bone density measurements of the hip, lumbar spine, whole body and heel, clinical risk markers for osteoporosis and metabolic disease, nutritional status and a balance tests in 2007-2009.

Women interested in participating in the study got an invitation to a study visit. During the study visit, written and oral information about the study was being given and then the women signed an informed consent.

Examinations in the cross sectional study

1. Clinical examination of the back, assessment of kyphosis, body weight and height, assessment of quality of life with SF-36 (Short Form-36) Health Survey) \[16, 17\], Qualeffo-41(Quality of life questionnaire of the European Foundation for Osteoporosis) \[18, 19, 20\] and EQ-5D (EuroQol-5Dimensions) Manual Balance Test, assessment of Back Extensor muscle strength. Evaluation of hand grip strength with a JAMAR hydraulic hand dynamometer.

   Assessment of physical performance and back pain using questionnaires, VAS (Visual Analogue Scale) scale and Borg CR-10 (Categoric Rate). Previous frequency of falls. Use of drugs and analgesics. Examination with spirometry and PEF (Peak Expiratory Flow).
2. Referral to X-ray of the thoracic and lumbar spine for assessment of the occurrence of vertebral fractures.

Randomized controlled trial: The investigators expect to recruit at least 108 women, randomized to three treatment arms with approximately 36 women in each arm.

1. Treatment with the activating spinal orthotic Spinomed (Medi-Bayreuth, Bayreuth Germany), maximum of two hours per day with gradual escalation of the time initially. Adaptation of the spinal orthotic is to be performed by an orthopedic technician.
2. Equipment training group led by a physiotherapist once a week with a special training program tailored to elderly women with osteoporosis and back pain.
3. Control group. Power calculation Primary endpoints in the treatment study are a change in experienced back pain, measured with VAS scale and Borg CR-10.

With a sample size of 99 subjects, I e 33 women in each arm analyzed by ANOVA, 88% power at the alpha 5% level is able to detect if there is a difference between the groups. With a possible anticipated drop-out of about 10% of the participants during the study, the investigators have decided to include 36 women in each group, I e a total of 108 women.

Recruitment

1. Participation is offered to women aged ≥ 60 years from the Primos project.
2. Recruitment through an invitation of women aged ≥ 60 years who participated in osteoporosis school in the last five years at Rehab City Kungsholmen.
3. Recruitment through advertisements in daily newspapers and ads in appropriate web forums (eg website for the National Association of Osteoporotic ROP) Flow chart Baseline

1. Clinical examination of the back, assessment of spinal curvature and of muscle strength of the back extensors, measurement of weight and height, assessment of health related quality of life with SF-36 \[16, 17\], Qualeffo-41 \[18, 19, 20\] and EQ-5D \[21\]. Manual balance test. Evaluation of hand grip strength with JAMAR dynamometer.

Assessment of physical performance and perceived pain using questionnaires, VAS scales and Borg CR-10. Examination with spirometry and PEF. Assessment of previous falls during the last year and other risk factors for osteoporotic fractures. Use of drugs and analgesics.

2. Referral to X-ray of the thoracic and lumbar spine for assessment of the occurrence of vertebral fractures. 3. Blood sample of 20 ml venous blood for analysis of substance P and CGRP (Calcitonin Gene Related Peptide) and IL-6 (Interleukin-6). Storage of samples: frozen in -70gr freezer until analyzes at a special research laboratory where one of the co-worker in the study is responsible for the analyzes.

Collaboration with the same radiological clinic at Karolinska University Hospital Solna for all X-ray examinations.

Follow-up after 1 month Pain drawing, pain measured by VAS-scale and Borg CR-10. For the spinal orthotic group adjustment of the spinal orthotic. Report of falls during last month. Use of drugs and analgesics.

Visit 2 after 3 months Clinical examination: functional assessment of the back, muscle strength of the back extensors, hand grip strength with JAMAR, pain drawing, manual balance test, back pain measured by VAS scale and Borg CR-10, EQ-5D, SF-36, Qualeffo-41. Adjustment of spinal orthotic. Spirometry. Weight and height. Report of falls since visit 1. Use of drugs and analgesics.

Visit 3 after 6 months Clinical examination: Functional assessment of the back. Manual balance test, muscle strength of the back extensors, grip strength with JAMAR, pain drawing, back pain measured by VAS-scale and Borg CR-10, EQ-5D, SF-36, Qualeffo-41. Spirometry. Weight and height. Assessment of spinal curvature. Report of falls since 3 month visit. Use of drugs and analgesics. Blood sample for substance P, IL-6 and CGRP analysis (Calcitonin Gene Related Peptide).

Qualitative group interviews in the Spinomed groups, using a semi-structured interview guide will be performed after the participants have completed their participation in the RCT.

Follow-up 12 months after study start Women in the group treated with the spinal orthotic Spinomed may continue to use the orthotic on their own initiative between 2 hours to a maximum of 4 hours per day, but without follow-up until after six months. Follow-up with reporting falls in a logbook once a week.

Women in the equipment training group receive a home exercise program they can continue at home, but without follow-up until after six months Visit 4 six months after end of treatment Clinical examination: Functional assessment of the back, manual balance test, muscle strength of the back extensors, hand grip strength with JAMAR, pain drawing, back pain measured with VAS scale and Borg CR-10. EQ-5D, Qualeffo-41, SF-36, Spirometry, Weight and height. Falls frequency. Assessment of spinal curvature. Use of drugs and analgesics.

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

* 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

Primary outcomes:
measure: Back pain
timeFrame: Baseline and six months
Secondary outcomes:
measure: Back muscle extensor strength
timeFrame: Baseline and six months
measure: Borg CR-10
timeFrame: Baseline and six months
measure: Kyphosis
timeFrame: Baseline and six months
measure: Substance P
timeFrame: Baseline and six months
measure: CGRP Calcitonin Gene Related Peptide
timeFrame: Baseline and six months
measure: IL-6 Interleukin
timeFrame: Baseline and six months
measure: Lung function
timeFrame: Baseline and six months
measure: Balance
timeFrame: Baseline and six months
measure: Gait speed
timeFrame: Baseline and six months
measure: SF-36
timeFrame: Baseline and six months
measure: QUALEFFO-41
timeFrame: Baseline and six months
measure: EQ-5D
timeFrame: Baseline and six months
measure: Hand grip strength
timeFrame: Baseline and six months
measure: Height
timeFrame: Baseline and six months
measure: Log book
timeFrame: Baseline and six months
measure: Paindrawing
timeFrame: Baseline and six months
measure: Falls
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Rehab City
city: Stockholm
country: Sweden
facility: Liljeholmen Academic Health Centre
Study officials:
affiliation: Karolinska Institutet
name: Eeva Helena S Salminen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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