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The Effects of Chiropractic Care in Adults With Subclinical Spinal Pain

R

Riphah International University

Status

Completed

Conditions

Subclinical Spinal Pain

Treatments

Other: Control Group
Other: Chiropractic Care

Study type

Interventional

Funder types

Other

Identifiers

NCT05369156
REC/01288 Imran Amjad

Details and patient eligibility

About

This study aims to investigate long term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in adults with subclinical pain.

Full description

There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function. A single session of chiropractic adjustment has shown to alter pre-frontal cortex (PFC) activity, but there is a lack of robust research investigating the long-term benefits of such PFC changes. This study aims to investigate long term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in adults with subclinical pain. In these parallel-group randomized controlled trials, participants aged 18-60 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), serum Brain-Derived Neurotrophic Factors (BDNF) levels and resting-state electroencephalography (EEG). The secondary outcomes include PFC activity (measured by cognitive and behavioral testing), immune and inflammatory markers and health-related quality of life. As data collected in the project is a combination of extrinsic (sociodemographic, clinical questionnaires etc.) and intrinsic physiological data (physiological measures like EEG, HRV etc.), the machine learning or artificial intelligence (AI) will be used to help the development of optimal chiropractic care plans in future.

Enrollment

120 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • aged between 18 and 60 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
  • they have uncontrolled asthma
  • have nasal polyps
  • use of an intranasal steroid spray one month or less before the study
  • are HIV-positive
  • unable or unwilling to comply with the study protocol
  • a history of drug abuse
  • are participating in another research study during the time of data collection.
  • have any diagnosed comorbidity or concomitant disease
  • donated blood within last month
  • have allergies to yeast or yeast-derived products
  • have chronic sinusitis and/ or recent (within the last six weeks) episodes of acute sinusitis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 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

Trial contacts and locations

1

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Central trial contact

IMRAN AMJAD, PhD

Data sourced from clinicaltrials.gov

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