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Learn more about In Review
Study protocol
Ziping Li
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL) (7). It is often accompanied by arthralgia, stiffness and limited lumbar flexibility. Acupuncture is safe and effective for reducing the symptoms of AS, but the underlying mechanisms by which it does so are not fully understood. Therefore, to objectively assess acupuncture efficacy, which is critical for patients making informed decisions about appropriate treatments, we will use shear-wave elastography (SWE) and superb microvascular imaging (SMI) ultrasound techniques to evaluate elasticity of lumbar paraspinal muscles and blood flow to the sacroiliac joint (SIJ) in AS.
Methods: We will recruit a total of 70 participants diagnosed with AS and 30 healthy subjects. Participants will be randomly allocated 1:1 to either an acupuncture group or a sham control acupuncture group. Primary-outcome measures will be musculoskeletal ultrasound and the Bath Ankylosing Spondylitis Metrology Index (BASMI). Secondary-outcome measures will be the Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Function Index (BASFI), Fatigue Scale-14 (FS-14), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS). We will monitor the effect of acupuncture or sham acupuncture on blood flow and SIJ inflammation using SMI, lumbar-muscle stiffness using SWE and the lumbar paraspinal-muscle cross-sectional area (CSA) using two-dimensional (2D) grayscale imaging. QoL, physical function and fatigue will be assessed using an evaluation scale or questionnaire developed for this study, with outcomes measured by the ASQoL, BASMI, BASDAI, BASFI and FS-14. Mental state will be evaluated using the SAS and SDS. Healthy subjects will not receive acupuncture but undergo only musculoskeletal ultrasound at baseline. Acupuncture and sham control acupuncture interventions will be conducted for 30 min, 2–3 times/week for 12 weeks. Musculoskeletal ultrasound will be conducted at baseline and post-intervention, while other outcomes will be measured at baseline, 6 weeks and post-intervention. The statistician, outcome assessor and participants will be blinded to treatment allocation.
Discussion: The results of this single-blinded, randomized trial with sham controls could help demonstrate the efficacy of acupuncture and clarify whether musculoskeletal ultrasound could be used to evaluate AS.
Trial registration: Chinese Clinical Trial Registry, ChiCTR2000031476. Registered April 3, 2020. http://www.chictr.org.cn/index.aspx.
Keywords
Acupuncture, Ankylosing spondylitis, Musculoskeletal ultrasound, Physical dysfunction
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- SPIRITFillablechecklist15Aug2013.doc
SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents.
- InformationLeafletforInformedConsentinchinese.doc
Information Leaflet for Informed Consent (in Chinese).
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Ziping Li
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 25 Mar, 2021
No community comments so far
Editor assigned
On 21 Mar, 2021
Submission checks complete
On 21 Mar, 2021
First submitted
On 12 Jan, 2021
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL) (7). It is often accompanied by arthralgia, stiffness and limited lumbar flexibility. Acupuncture is safe and effective for reducing the symptoms of AS, but the underlying mechanisms by which it does so are not fully understood. Therefore, to objectively assess acupuncture efficacy, which is critical for patients making informed decisions about appropriate treatments, we will use shear-wave elastography (SWE) and superb microvascular imaging (SMI) ultrasound techniques to evaluate elasticity of lumbar paraspinal muscles and blood flow to the sacroiliac joint (SIJ) in AS.
Methods: We will recruit a total of 70 participants diagnosed with AS and 30 healthy subjects. Participants will be randomly allocated 1:1 to either an acupuncture group or a sham control acupuncture group. Primary-outcome measures will be musculoskeletal ultrasound and the Bath Ankylosing Spondylitis Metrology Index (BASMI). Secondary-outcome measures will be the Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Function Index (BASFI), Fatigue Scale-14 (FS-14), Self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS). We will monitor the effect of acupuncture or sham acupuncture on blood flow and SIJ inflammation using SMI, lumbar-muscle stiffness using SWE and the lumbar paraspinal-muscle cross-sectional area (CSA) using two-dimensional (2D) grayscale imaging. QoL, physical function and fatigue will be assessed using an evaluation scale or questionnaire developed for this study, with outcomes measured by the ASQoL, BASMI, BASDAI, BASFI and FS-14. Mental state will be evaluated using the SAS and SDS. Healthy subjects will not receive acupuncture but undergo only musculoskeletal ultrasound at baseline. Acupuncture and sham control acupuncture interventions will be conducted for 30 min, 2–3 times/week for 12 weeks. Musculoskeletal ultrasound will be conducted at baseline and post-intervention, while other outcomes will be measured at baseline, 6 weeks and post-intervention. The statistician, outcome assessor and participants will be blinded to treatment allocation.
Discussion: The results of this single-blinded, randomized trial with sham controls could help demonstrate the efficacy of acupuncture and clarify whether musculoskeletal ultrasound could be used to evaluate AS.
Trial registration: Chinese Clinical Trial Registry, ChiCTR2000031476. Registered April 3, 2020. http://www.chictr.org.cn/index.aspx.
Figure 1
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