The Effects of Chiropractic Care and Children With Subclinical Spinal Pain

Riphah International University

Status: Completed

Conditions: Subclinical Spinal Pain

Treatments: Other: Chiropractic care; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05369143

REC/01286 Imran Amjad

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 2 patient groups, including a placebo group

Chiropractic care Group

Experimental group

Description:

A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor with at least five years of clinical experience.The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. Chiropractors use these biomechanical characteristics as clinical indicators of spinal dysfunction and vertebral subluxation.

Treatment:

Other: Chiropractic care

Control Group

Placebo Comparator group

Description:

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 control 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. No spinal adjustment will be performed during any control intervention. This control intervention is not intended to act as a sham treatment session

Treatment:

Other: Control Group