Clinical Trials in Degenerative Diseases

RESEARCH ARTICLE
Year
: 2018  |  Volume : 3  |  Issue : 2  |  Page : 59--65

Three methods for reducing back pain in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine: protocol for a non-randomized controlled trial with 2-year follow-up and preliminary results


Kai Wang, Chun-Liang Li, Hai-Yong Zhu, Yu Wang, Zhi-Jin Zhang 
 Qinghai Provincial People’s Hospital, Xining, Qinghai Province, China

Correspondence Address:
Chun-Liang Li
Qinghai Provincial People’s Hospital, Xining, Qinghai Province
China

Abstract

Background and objectives: Osteoporotic vertebral compression fracture of the thoracolumbar spine manifests clinically as back pain. Percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) are the preferred treatment methods for this disorder. Our previous studies have shown that both procedures effectively reduce back pain at 6 months post-surgery in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine. Little is documented about longer-term pain relief after PKP and PVP. The aim of this prospective, single-center, non-randomized, controlled trial is to investigate long-term and medium-term back pain relief after PKP, PVP, and non-surgical treatment of this condition and to analyze risk factors for ongoing back pain. Design: A prospective, single-center, non-randomized, controlled trial. Methods: This study will include 900 patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine scheduled to receive treatment at Qinghai Provincial People’s Hospital. Patients will be assigned to receive PKP, PVP, or nonsurgical treatment (rehabilitation and traditional Chinese medicine; n = 300 per treatment method). Patients will have follow-up evaluation at 1 week and 1, 3, 6, 12, and 24 months. Outcome measures and preliminary results: The primary outcome measure is the prevalence of back pain 24 months post-surgery. Secondary outcome measures are prevalence of back pain at other time points; Visual Analogue Score, Oswestry Disability Index, Japanese Orthopedic Association score, and X-ray morphology before surgery and at all postoperative time points; and incidence of adverse events at each postoperative time point. A pilot study of 621 patients with osteoporotic vertebral compression fracture of the thoracolumbar spine revealed that Visual Analogue Score and Oswestry Disability Index were significantly lower 6 months postoperatively than prior to PKP or PVP, with only 15% of patients having ongoing back pain. Risk factors for back pain were bone cement leakage (direction, volume, and scope) and adverse reactions (P < 0.05). This study’s findings will help clarify the optimal treatment for back pain relief in patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine. Ethics and dissemination: The study protocol was approved by Medical Ethics Committee, Qinghai Provincial People’s Hospital of China in April 2017 (approval No. RM006G). This study will be performed in strict accordance with the Declaration of Helsinki developed by the World Medical Association. Written informed consent will be obtained from each patient. The study protocol was designed in March 2017. Patient recruitment and data collection will begin in September 2018. Patient recruitment will end in September 2019. Data analysis will be performed in October 2021. The whole study will end in November 2021. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016493). Protocol version: 1.0.



How to cite this article:
Wang K, Li CL, Zhu HY, Wang Y, Zhang ZJ. Three methods for reducing back pain in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine: protocol for a non-randomized controlled trial with 2-year follow-up and preliminary results.Clin Trials Degener Dis 2018;3:59-65


How to cite this URL:
Wang K, Li CL, Zhu HY, Wang Y, Zhang ZJ. Three methods for reducing back pain in older adults with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine: protocol for a non-randomized controlled trial with 2-year follow-up and preliminary results. Clin Trials Degener Dis [serial online] 2018 [cited 2024 Mar 28 ];3:59-65
Available from: https://www.clinicaltdd.com/text.asp?2018/3/2/59/235149


Full Text

 Introduction



Background

Osteoporosis is a systemic metabolic disease that occurs frequently in elderly people and postmenopausal women. The incidence of age-related osteoporotic vertebral compression fracture of the thoracolumbar spine is very high because osteoporosis increases bone fragility, and the thoracolumbar spine is the focal point for mechanical stresses.[1],[2],[3],[4] Most older adults with age-related osteoporosis have concurrent diseases such as hypertension and diabetes, which may directly influence the effects of treatment for vertebral compression fracture of the thoracolumbar spine. For example, post-fracture bed rest affects the rehabilitation and treatment of systemic diseases, and intraoperative trauma and stress may influence the treatment of osteoporosis.[5],[6] Osteoporotic vertebral compression fracture of the thoracolumbar spine can cause severe back pain that greatly restricts a patient’s movement, even causing patients to be bedridden or unable to care for themselves, and greatly influences quality of life.[7],[8]

The principles of treatment of osteoporotic vertebral compression fracture of the thoracolumbar spine are to reduce pain, improve quality of life, increase bone strength and bone density, avoid ongoing vertebral compression, and restore vertebral body height.[7],[8] There is controversy regarding the best treatment for osteoporotic vertebral compression fracture of the thoracolumbar spine. Some scholars recommend drug treatment because of its minimal invasion and few complications. Others prefer surgical treatment because of rapid onset of action and encouraging efficacy. Percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) are the major treatments for osteoporotic vertebral compression fracture of the thoracolumbar spine. These two treatment methods can rapidly reduce pain and improve quality of life.[9],[10],[11],[12] [Table 1] lists the clinical trials of treatments for osteoporotic vertebral compression fracture of the thoracolumbar spine in China.[13],[14],[15]{Table 1}

Features of this study

Our previous results revealed that PKP and PVP effectively reduced back pain in patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine at 6 months post-surgery. Little is documented about longer-term back pain relief after PKP and PVP.[16] This prospective, single-center, non-randomized, controlled trial will investigate the longer-term effects of PKP and PVP on back pain relief.

Study objective

The aim of this study is to investigate differences in medium- and long-term back pain relief after PKP, PVP, and non-surgical treatment of age-related osteoporotic vertebral compression fracture of the thoracolumbar spine in older adults.

 Methods/Design



Study design

A prospective, single-center, non-randomized controlled 2-year follow-up trial.

[INLINE:1]

Study setting

Qinghai Provincial People’s Hospital, Xining, China.

Recruitment

Recruitment will be performed using posters on a bulletin board that advertises to patients in the clinics and wards at Qinghai Provincial People’s Hospital. Posters will provide detailed information regarding the trial. Patients interested in participation or their close relatives will contact the project manager by telephone, e-mail, or WeChat. After completing the necessary paperwork, eligible patients will be considered for inclusion. Included patients will be treated and followed up regularly according to the treatment plan.

Eligibility criteria

A total of 900 older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine will be included in this study.

Diagnostic criteria of osteoporosis

Osteoporosis will be diagnosed as –2.0 SD or 25% reduction in bone mass and bone mineral density < 80 mg/cm[3] as determined by quantitative CT, in accordance with the Expert Consensus on the Diagnosis of Osteoporosis in Chinese Population (3rd ed., 2014).[17]

Diagnostic criteria of osteoporotic vertebral compression fracture of the thoracolumbar spine[18]:

- Presence of osteoporosis

- Change in the signal of fractured vertebral body on MRI, suggesting edema, decreased vertebral height, endplate collapse, visible fracture line or fluid in the vertebral body; collapse of the endplate, visible fracture line, or fluid in the vertebral body on CT

- Clinical manifestations of lumbar movement disorder, posterior deformity, and inability to tolerate long-term bed rest

Inclusion criteria

Patients with all of the following will be considered for inclusion:

- Meeting the above diagnostic criteria

- Age > 65 years

- Fracture occurrence within previous 1 week

- Tight compliance and provision of written informed consent

Exclusion criteria

Patients with any of the following conditions will be excluded from this study:

- Tumor in the vertebral body

- Vertebral burst fracture

- Vertebral tuberculosis

- Suppurative infection

- Old fracture

Grouping and blinding

Nine hundred older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine will be divided into three groups according to treatment method (PKP, PVP, or nonsurgical treatment), on the basis of the patient’s condition and wishes (n = 300/group). Patients in the PKP and PVP groups will undergo PKP and PVP, respectively. Patients in the nonsurgical treatment group will receive rehabilitation training and traditional Chinese medicine. Randomization and blind grouping will not be used in this study.

Interventions

PKP group

Preoperative preparation: To avoid accidents and the need for first-aid treatment, intravenous channels will be established before surgery and ECG monitoring will be performed. Lidocaine will be used for local anesthesia. Patients will be placed in the prone position. Soft pillows will be placed under the patient’s chest and thighs. A 0.5-cm incision will be made in the skin for puncture through a pedicle approach. Puncture: The vertebral body to be operated will be identified with C-arm fluoroscopy. If puncture is performed via the left pedicle, the entry point will be at the 10:00 o’clock position relative to the outer edge of the pedicle. If the puncture is performed via the right pedicle, the entry point will be at the 2 o’clock position relative to the outer edge of the pedicle. Needle insertion: In the anterior-posterior approach, the tip of needle will be inserted at the established position at the outer edge of the pedicle. In the lateral approach, the tip of the needle will pass across the pedicle. With the anterior–posterior approach, when the needle tip nears the inner edge of the pedicle, the tip of the needle in the lateral approach should have passed through the pedicle and across the posterior edge of the vertebral body. At that time, an expansion balloon will be placed and an injection device will be connected to expand the balloon. The balloon will be removed at appropriate pressure, and bone cement will be injected into the vertebral body at the stage of wire withdrawal. Bone cement will not be injected until satisfactory filling is achieved. Surgical devices will then be removed as soon as possible to avoid removal difficulty from solidified bone cement. PKP procedure is shown in [Table 1].

PVP group

PVP will be performed in accordance with a previously described method.[19] The main differences from the above procedure are that in the anterior–posterior projection, the drill will be close to the centrum of the vertebral body; in the lateral projection, the drill will be close to the anterior edge of the vertebral body. Then the drill bit will be removed and bone cement will be directly injected.

Nonsurgical treatment group

Rehabilitation training: Professional rehabilitation training will be performed by rehabilitation therapists from the Department of Rehabilitation of Qinghai Provincial People’s Hospital. The rehabilitation training includes horizontal traction (with waist and back muscles relaxed, the lower limbs will be gradually raised to put the waist and back in a hyperextended state and the fractured area will be pressed and gently massaged with the palm); functional training and reposition training; and physical therapy (local acupuncture with moxibustion and acupoint dressing). Drug treatment: Fufang Duzhong Jiangu Keli (CR Double-Crane Pharmaceuticals Co., Ltd., China), taken after mixing with boiling water, 12 g per dose, three times per day, for 1 month as one treatment session.

Outcome measures

Primary outcome measure

Prevalence of back pain at 24 months post-surgery: The number of patients having back pain at 24 months post-surgery will be counted. Prevalence of back pain = the number of patients with back pain/total number of patients × 100%.

Secondary outcome measures

- Prevalence of back pain at 1 week and 1, 3, 6, and 12 months post-surgery: Evaluation criteria are the same as above.

- Visual Analogue Score (VAS) at baseline (prior to surgery) and at 1 week and 1, 3, 6, 12, and 24 months post-surgery: VAS scores range from 0 to 10 points. Higher scores indicate more severe back pain.[20]

- Oswestry Disability Index (ODI) at baseline and at 1 week and 1, 3, 6, 12, and 24 months post-surgery: The ODI will be used to evaluate patients’ motor function recovery. The ODI questionnaire includes 10 parameters, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each parameter has six choices. The highest score for each parameter is 5 points. Higher scores indicate more severe disability and greater effects on quality of life.[21]

- Japanese Orthopedic Association (JOA) score at baseline and at 1 week and 1, 3, 6, 12, and 24 months post-surgery: The JOA score ranges from 0 to 29. Lower scores indicate more severe dysfunction.[22]

- X-ray morphology of the thoracolumbar spine at baseline and at 1 week and 1, 3, 6, 12, and 24 months post-surgery: The morphology of the thoracolumbar spine will be observed on X-ray images.

- Incidence of adverse events at 1 week and 1, 3, 6, 12, and 24 months post-surgery. Adverse events (bone cement leakage, infection, wound nonunion, and recurrence of vertebral body fracture) will be recorded at each time point. Incidence of adverse events = number of patients with adverse events/total number of patients × 100%.

Primary and secondary outcome measures and schedules are shown in [Table 2].{Table 2}

Adverse events

The adverse events occurring during the follow-up period will be recorded. The first onset time, severity, and management of adverse events will be recorded and reported to the project manager and the study’s ethics committee within 24 hours.

Trial procedure

A total of 900 older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine will be included in this study [Figure 2].{Figure 1}{Figure 2}

Sample size

In accordance with our previous results 16 and clinical experience, we hypothesized that the incidence of back pain after surgery in the PKP and non-surgical treatment groups will be 5% and 15%, respectively. Assuming β = 0.2, power = 80%, α = 0.05 (two-sided), a final sample size of n = 250 per group was calculated using the PASS 11.0 software (PASS, Kaysville, UT, USA). Assuming a participant loss rate of 20%, we will require a sample size of n = 300 per group. Therefore, a total sample size of 224 will be used in this study.

Statistical analysis

Data description

All data will be statistically processed using the SPSS 19.0 software (IBM, Armonk, NY, USA) following the intention-to-treat principle. Normally distributed measurement data will be expressed as means and standard deviations. Non-normally distributed data will be expressed as lower quartiles (q1), medians, and upper quartiles (q3). Count data will be expressed as percentages.

Selection of statistical methods

A chi-square test for association will be performed to compare the incidences of back pain and adverse events between PKP, PVP and non-surgical treatment groups at various time points. Two-way repeated measures analysis of variance will be performed to compare the VAS, ODI, and JOA scores between three groups at various time points. The least significant difference will be used for comparison between groups. Main effects and interactions will be calculated. Multivariate Logistic regression analysis will be used to analyze the risk factors. OR and 95% CI values will be calculated. An inspection level of α = 0.05 (bilateral) will be considered.

Data sets

The patients included in the final analysis are mainly the population assigned to the per protocol set.

Data collection and management

Data collection

Case report forms will be filled by the investigators accurately, completely, and on time. Written records will be transferred to an electronic format by professional staff using a double data entry strategy.

Data management

Research data will be statistically analyzed and reported by professional statisticians. A final report will be made by principle investigators and the database will be locked. All data relating to this study will be preserved by Qinghai Provincial People’s Hospital, China.

Monitoring

Independent Data Monitoring Committee composition

The role and responsibilities of the Independent Data Monitoring Committee relative to the investigators and ethics committee will be identified. The role and responsibilities of the Independent Data Monitoring Committee will be relative to the project steering committee, clinical pharmacologists and/or toxicologists, epidemiologists, statisticians, clinical trial managers, and ethics experts.

Investigator qualification

All surgeons participating in this study have a wealth of experience in similar operations and can skillfully perform surgical procedures. All surgeries will be performed by senior orthopedic surgeons. Physicians responsible for pain scoring and imaging evaluation should have underwent professional training and have abundant experience in this research field.

Auditing

The monitors will visit the trial institute regularly or according to the actual situation to carry out clinical quality audit work. The monitors will report the progress of the trial to the Ethics Committee every 2 months and update the trial progress in the registration database.

Compensation to patients

Patients included in the clinical trial will be followed up closely by professional medical teams without charge. They can be compensated in follow-up-related examination and registration fees.

Ethics and dissemination

This study was approved by Medical Ethics Committee, Qinghai Provincial People’s Hospital, China (approval No. RM006G).

The study protocol was developed based on the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statements (Additional file 1 [SUPPORTING:1]). This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from each patient. When the investigators discover that there are risks beyond expectations in the clinical trials, they will modify the contents of the informed consent together with the sponsors. After the approval of relevant working procedures has been achieved from the ethics committee, the affected patients or their guardians will re-sign the modified informed consent forms. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Anonymized trial data will be published at www.figshare.com.

Preliminary results

At the time of submission, the results of 621 older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine have been acquired.[16]

Data retrieval: Clinical data of 621 patients with osteoporotic vertebral compression fracture of the thoracolumbar spine who received treatment at our hospital between January 2013 and January 2016 were retrospectively analyzed. All 621 patients underwent PKP or PVP. Comparisons of VAS and ODI before versus 6 months after surgery: The mean VAS and ODI were significantly lower after surgery than before surgery (P < 0.05). After surgery, 94 (15%) of 621 patients had persistent back pain. One-way analysis of back pain at 6 months post-surgery: Age, preoperative VAS score for back pain, preoperative bone mineral density, amount of bone cement injected into a single vertebral body, bone cement leakage, number of foci, direction and scope of bone cement leakage, and postoperative complications were closely associated with back pain in older adult patients with osteoporotic vertebral compression fracture of the thoracolumbar spine (P < 0.05). Multiple-factor logistic regression analysis of back pain at 6 months post-surgery: Postoperative bone cement leakage, leakage direction, amount and scope of bone cement, and complications were risk factors for back pain in patients with osteoporotic vertebral compression fracture of the thoracolumbar spine (P < 0.05).

 Discussion



Previous contributions and existing problems

PKP and PVP are the major surgical methods for the treatment of osteoporotic vertebral compression fracture of the thoracolumbar spine. The therapeutic efficacy of these procedures has been confirmed.[9],[10],[11],[12] However, back pain persists in some patients after surgery. Our previous studies revealed that both PKP and PVP can greatly reduce back pain in patients with osteoporotic vertebral compression fracture of the thoracolumbar spine. However, postoperative leakage of bone cement and complications may cause back pain.[16]

Novelty of this study

We previously investigated back pain 6 months after surgery in patients with osteoporotic vertebral compression fracture of the thoracolumbar spine who underwent PKP or PVP.16 In the present proposed study, we will lengthen the follow-up period to 24 months and investigate medium- and long-term back pain in patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine who undergo PKP, PVP, or non-surgical treatment.

Limitations of this study

In this study, patients will be divided according to the treatment method used. Randomized grouping will not be used. This study design may influence the accuracy of results to some degree, a limitation that will be addressed in future studies.

Significance of this study

This study will identify whether PKP, PVP, or non-surgical treatment results in better long-term effects in reducing back pain in older adults with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine.

Additional file

Additional file 1: SPIRIT checklist.

Author contributions

Conception and design of this study: KW; patient recruitment: CLL and HYZ; data collection and analysis: YW and ZJZ. All authors approved the final version of this manuscript.

Conflicts of interest

There are no conflicts of interest.

Financial support

None.

Institutional review board statement

This study protocol will be performed in strict accordance with the Declaration of Helsinki. This study was approved by Medical Ethics Committee, Qinghai Provincial People’s Hospital, China in April 2017 (approval No. RM006G). Surgeons participating in this trial should have met the qualification requirements for ultrasound and magnetic resonance imaging examination.

Declaration of patient consent

The authors certify that they will obtain all appropriate patient consent forms. In the form the patients will give their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Reporting statement

This study follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statements.

Biostatistics statement

The statistical methods of this study were reviewed by the biostatisticians of Qinghai Provincial People’s Hospital, China.

Copyright license agreement

The Copyright License Agreement has been signed by all authors before publication.

Data sharing statement

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. Study protocol and informed consent will be available immediately after publication, no end date. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Anonymized trial data will be available indefinitely at http://www.clinicaltdd.com.

Plagiarism check

Checked twice by iThenticate.

Peer review

Externally peer reviewed.

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