Vol 4-3 Research Article

Is there a correlation between hypermobility of the spine and chronic neck/back pain in young adults?

This cross-sectional study aimed to explore the correlation between hypermobility of the spine and chronic neck/back pain in a university-aged population. Chronic musculoskeletal pain, especially joint pain, is said to be the main complaint of individuals with symptomatic joint hypermobility. Generalized joint hypermobility is usually limited to a small number of joints, with increased range of motion of the lumbar spine the most common form of joint hypermobility. The study collected data over a six-year period from undergraduate Anatomy & Physiology students at a university in the United States, using an anonymous survey. Based on the data from 1,211 respondents the study found that: 1) young adult females are more likely to have hypermobility of the spine than young adult males; 2) young females with spine hypermobility are not more likely to report chronic neck/back pain than females without spine hypermobility; 3) young adult males with spine hypermobility are more likely to report chronic neck/back pain than males without spine hypermobility; 4) young females and males with spine hypermobility experience the same average levels of pain intensity for their chronic neck/back pain than their peers without spine hypermobility; 5) young females with and without spine hypermobility report higher levels of chronic pain intensity than males for chronic neck/back pain.

DOI: 10.29245/2767-5130/2023/3.1185 View / Download Pdf
Vol 4-3 Mini Review

Os Odontoideum - "MR documented Craniocervical Ligamentous Injury in Early Childhood with delayed formation of Os Odontoideum on Sequential Imaging". Case-based Review and Mini Database Analysis

The etiology of os odontoideum has been debated ever since its first description by Giacomini in 1886. There are proponents of congenital origin as well as reports of post-traumatic os odontoideum formation after early childhood craniovertebral junction (CVJ) trauma. We document CVJ ligamentous injury on MRI in an 18-month-old child with sequential imaging demonstrating the os odontoid formation. Our database of 260 surgically treated patients with os odontoideum was analyzed regarding etiology and associated abnormalities. The literature (1970-2022) is reviewed.

DOI: 10.29245/2767-5130/2023/3.1186 View / Download Pdf
Vol 4-3 Case Report

Posterior L5 Transversectomy and Decompression for Far-out Syndrome caused by Lumbosacral Transitional Vertebra: A Case Report

Far-out syndrome is an unusual type of Bertolotti’s syndrome refers to L5 nerve root compressed by osteophyte in the extraforaminal zone, which leads to radical pain of the leg by radiculopathy. Conservative treatment is generally ineffective and requires operative decompression. We present the case of a 19-years-old patient complained of pain in the right lumbosacral and lower leg, failed for 2 months of conservative treatment. The patient was confirmed as far-out syndrome by imaging examinations showed the right L5 nerve root compressed by osteophytes from pseud arthrosis between the L5 transverse process and sacral ala. The Visual analog scale (VAS) pain score was 6 and the Oswestry disability index (ODI) was 53.33%. Then the osteophytes and pseudarthrosis were surgical removed and the L5 nerve root was decompressed through a posterior approach. The patient’s symptoms were significantly relieved after surgery immediately. The VAS score was 1 and ODI was 15.56% at 1-month postoperatively. At 1-year follow up, the VAS pain score was 1 and ODI was 11.11% and complete military trainings was resumed.

DOI: 10.29245/2767-5130/2023/3.1182 View / Download Pdf
Vol 4-3 Research Article

A Modified Study Design for Blinded Randomized Controlled Trial in Orthobiologic Therapy

Background: The utility of cellular based therapeutic agents in management of various ailments and conditions is promising, particularly in the field of orthopedics. However, an evidence-based medicine approach must be implemented to validate these novel cellular based therapies before they can be translated into routine clinical practice. Given pain relief is a primary goal of novel treatments for orthopedic disease, future orthobiologic clinical trials will need to overcome challenges such as the placebo effect or the placebo response and difficult participant recruitment. In this paper, we describe a clinical study that evaluates the safety and efficacy of autologous stromal vascular fraction (SVF) cells that adheres to a patient blinded, randomized and placebo-controlled study design while still offering the patient the opportunity to participate in the therapeutic intervention by using cell preservation techniques.

Methods: This pilot clinical trial studies the safety and feasibility of intra-articular transplantation of SVF cells in patients with knee osteoarthritis with secondary outcomes of improving pain relief. The RCT aims to recruit 30 patients. Liposuction is performed on each patient to isolate SVF cells. 15 subjects are randomized to receive SVF injection in the same surgical procedure and 15 subjects receive placebo injection directly into their affected knee joint. The placebo group’s SVF cells are then frozen and preserved. At the 6-month follow-up visit, those who received the placebo are unblinded and have the option to receive the SVF injection as a condition for participation in the trial. Feasibility of liposuction, SVF manufacturing, cell preservation/thaw techniques and adverse outcomes are all primarily tracked. Secondary outcomes include standardized patient reported outcomes score responses to the treatments.

Discussion: The design of this pilot study offers study subjects the opportunity to receive a novel therapeutic intervention even within a placebo arm and enables the investigators to blind subjects without performing an unnecessary liposuction or discarding the resulting cellular product which could encourage hesitant individuals to participate in the trial. This may aid in overcoming the challenges associated with recruiting participants for cell therapy trials concerned with being randomized to a control arm. The results of this trial will help to assess both the safety and feasibility of SVF injections to treat knee osteoarthritis as well as help plan larger phase controlled trials.

However, precautionary measures are necessary to ensure the safety and well-being of patients receiving cell-based therapy. Proper handling and storage of the cellular product must be considered and are demonstrated here.

Trial Registration

ClinicalTrials.gov Identifier: NCT03940950

DOI: 10.29245/2767-5130/2023/3.1183 View / Download Pdf