Subclinical Spinal Pain
Conditions
Brief summary
There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function.This study aims to investigate short term and long-term effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in children with subclinical spinal pain.
Detailed description
There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function. A single chiropractic adjustment session has been shown to alter pre-frontal cortex (PFC) activity in adults, but there is a lack of robust research investigating any long-term benefits of such PFC changes in children. This study aims to investigate short term and long-term effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in children with subclinical spinal pain. In this parallel-group randomized controlled trial, participants aged 10-18 years with subclinical spinal pain will be randomly allocated to receive either 12 weeks of CC intervention or control intervention. Primary outcomes include functional near-infrared spectroscopy, heart rate variability (HRV) and resting-state electroencephalography (EEG). The secondary outcomes include executive functions measured by cognitive testing, immune and inflammation status, and health-related quality of life. As data collected in the project is the combination of extrinsic (sociodemographic, clinical questionnaires etc.) and intrinsic physiological data (physiological measures like EEG, HRV etc.), we will utilize the advances in machine learning or artificial intelligence (AI) to help inform the development of optimal chiropractic care plans in future.
Interventions
OTHERChiropractic care
The mechanical properties of chiropractic adjustment have been investigated; and although the actual force applied to the patient's spine depends on the chiropractor, the patient, and the spinal location of the subluxation, the general shape of the force-time history of spinal adjustments is very consistent68 and the duration of the thrust is always less than 200 milliseconds.
OTHERControl Group
The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* aged between 10 and 18 years * have subclinical spinal pain
Exclusion criteria
* no evidence of spinal dysfunction is present * they are in current pain (above 3/10 on VAS) * have sought previous treatment for their spinal issues * are unable to perform the assessment procedures due to contraindications or movement limitations * diagnosed immune dysfunction * utilizing a prescribed immunosuppressive medication * have uncontrolled asthma * nasal polyps * use of an intranasal steroid spray one month or less before the study * are HIV-positive * are participating in another research study at the time of data collection * have any diagnosed comorbidity or concomitant disease * have allergies to yeast or yeast-derived products * have chronic sinusitis or recent (within the last six weeks) episode of acute sinusitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional near-infrared spectroscopy (fNIRS) | Base line | Functional near-infrared spectroscopy (fNIRS) is an optical imaging tool for noninvasive, continuous monitoring of regional blood flow and tissue oxygenation. It can measure two hemodynamic parameters, both deoxyhemoglobin (HHb) and oxyhemoglobin (HbO2), at the same time. It reflects changes in regional blood flow to areas of the brain involved in processing functional tasks (Cognitive tasks). A baseline assessment of a participant will be done before the start of the intervention. |
| Whole head EEG(sub-cohort of participants) | Base line | The EEG will be recorded from 40-scalp electrodes using the extended 10-20 system montage (Quick-Cap International). The participant will be seated comfortably in a chair with eyes closed throughout the entire recording. We will record a period of resting whole head EEG. We will use standardized low-resolution brain electromagnetic tomography (sLORETA) for the resting EEG to calculate potential changes (Spatio-spectral Analysis) in brain activity and communication post the chiropractic care intervention. A baseline assessment will be done before applying intervention. |
| Heart rate variability | Up to 16 Weeks | Heart rate variability (HRV) will be used as an objective assessment of psychological health and stress for the participants. High HRV is a marker of an adaptable, responsive nervous system that can detect sensory stimuli and appropriately increase or decrease the heart rate based on the needs of the individual. Low HRV and low parasympathetic activity is associated with chronic pain states, poor cardiovascular health and mood disorders. Heart Rate will be monitored throughout the session. Assessment of participants will be continued throughout the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paired Associate Learning (PAL) | Base line | Paired Associates Learning assesses visual memory and new learning Outcome measures include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed. A baseline assessment of a participant will be done before the start of the intervention. |
| Spatial working memory (SWM) | Base line | Spatial Working Memory requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory error. Outcome measures include errors (selecting boxes that have already been found to be empty and revisiting boxes that have already been found to contain a token) and strategy. Fewer errors mean good spatial working memory and vice versa for more errors. A baseline assessment of a participant will be done before the start of the intervention. |
| Reaction time (RTI) | Base line | Reaction Time provides assessments of motor and mental response speeds and measures of movement time, reaction time, response accuracy, and impulsivity. Outcome measures are divided into reaction time and movement time for both the simple and five-choice variants. It's a six-minute test that covers latency (response speed), correct responses and errors of commission and omission. More accurate reaction in less time inclines toward good reaction time. A baseline assessment of a participant will be done before the start of the intervention. |
| Stockings of Cambridge (SoC) | At Baseline | Stockings of Cambridge (SOC) is a test of spatial planning that requires individuals to use problem-solving strategies to match two sets of stimuli. A baseline assessment of a participant will be done before the start of the intervention. |
| Delayed Matching to Sample (DMS) | At Baseline | Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory for non-verbalizable patterns. A baseline assessment of a participant will be done before the start of the intervention. |
| Health-related quality of life | Base line | The health-related quality of life will be measured using the PROMIS Pediatric v2.0 profile 25, which assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. PROMIS Pediatric v2.0 profile 25 is a reliable and valid instrument that can be used to assess the impacts of health care interventions and track changes in health over time. A baseline assessment of a participant will be done before the start of the intervention. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Smartphone Gait and Balance Application | Baseline | The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject has to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and closed and standing on a compromised surface with eyes open and closed. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done at baseline. |
| Immune Function Questionnaire (IFQ) | At baseline | The Immune Function Questionnaire (IFQ) consists of 15 items that assess the frequency of various symptoms associated with poor immune function. There are 19 symptom items included on the questionnaire as signs of weakened immune system functioning: headaches, sore throat, eye infection, sinusitis, runny nose, flu, coughing, cold sores, boils, mild fever, pneumonia, bronchitis, warts/verrucas, sepsis, ear infection, diarrhea, meningitis, sudden high fever, and prolonged healing injuries. The IFQ score has been found to positively correlate with the number of visits to a General Medical Practitioner. A baseline assessment of a participant will be done before the start of the intervention. Calculate the sum score of the 7 IFQ items. To obtain the final IFQ score, translate the raw IFQ scores as follows: Interpretation: 0 = very poor, 10 excellent perceived immune status. |
| Hair Cortisol | Baseline | Cortisol can alter cytokine levels (such as increasing IL-6 pro-inflammatory cytokines) that then alter the levels of inflammation throughout the body. Cortisol could be measured from Hair samples. Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. Assessment of participants will be done at the baseline of the study. |
| Saliva Cortisol | Base line | Cortisol can alter cytokine levels (such as increasing IL-6 pro-inflammatory cytokines) that then alter the levels of inflammation throughout the body. Cortisol could be measured from saliva samples. Cortisol (otherwise known as the stress hormone) is made in the adrenal glands. It's elevated when we experience heightened anxiety or stress, and it's lowered when we're in a relaxed state. A baseline assessment of a participant will be done before the start of the intervention. |
| Inflammation markers from Fitbit data | Up to 16 Weeks | Fitbit can be used to measure the autonomic nervous system (ANS). Heart rate variability (HRV) has become a validated marker of autonomic function. In a large population-based study it was found that strong and independent relationships between HR and HRV with a broad set of inflammatory biomarkers. The recording will be done for up to 16 weeks. |
Countries
Pakistan
Outcome results
None listed