NCT06036849

Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation

Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation: a Randomized Mechanistic Cross-over Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Balgrist University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The investigators aim to investigate the relationship between delivery kinetics, physiological responses and clinical outcomes following spinal manipulation. Neck pain participants will be randomised to attend two intervention sessions and will receive either a single cervical spine manipulation or mobilization (one set of central posterior-anterior mobilizations applied with either a crossed-thumb or pisiform contact) at the most painful level. Participants without neck pain will attend a single experimental session, where all measurement procedures will be the same as for neck pain participants with the exception that no treatment will be delivered.

Detailed description

For participants with neck pain, physiological responses \& clinical outcomes associated with cervical spine manipulation and mobilization will be recorded. Both treatments will be delivered by several registered, practicing and experienced clinicians. A targeted history \& physical examination will be conducted at the beginning of each experimental session to ensure it is ethical to proceed. Pre-treatment questionnaires regarding pain and treatment expectation will be completed. The participant will be instrumented with electromyographic and galvanic skin response sensors and required to wear a chest strap to measure heart rate variability. The participant will then lie in a quiet room for 10-15 minutes while baseline data is recorded. Following this, the treatment will be delivered \& responses measured. After the treatment, the participant will again lie in a quiet room for 10-15 minutes while post-treatment data is recorded. Before leaving, all sensors will be removed and post-treatment questionnaires will be completed. The participant will return after 72 hours, at the same time of day, for the second session with the alternate treatment. Participants without neck pain will attend a single experimental session, where all procedures will be the same as described above with the exception of treatment delivery and questionnaires describing neck pain changes following treatment. Each visit will take approximately 2-3 hours and will be performed at the Balgrist University Hospital.

Conditions

• Neck Pain

Interventions

Type	Name	Description
PROCEDURE	Spinal manipulation	The manipulation will be delivered to the articular pillar of the most painful level of the cervical spine, as determined by the patient history \& physical examination, by a registered and practicing chiropractor. The participant will be positioned supine with the head supported by the clinician's hands. The articular process of the involved vertebra will be contacted by the antero-lateral aspect of the proximal phalanx of the second digit of the clinician's index finger. The head will be taken into flexion, ipsilateral lateral flexion and contralateral rotation to the pre-manipulative position. A rapid, controlled low-amplitude thrust will be applied in a further posterior-anterior line of drive. Ipsilateral in this instance means the same side as the primary contact i.e. for manipulation applied to the right side, the right side of the participant's neck will be contacted.
PROCEDURE	Spinal mobilization	The mobilization will consist of one set of posterior-anterior spinal mobilization applied with either a crossed-thumb or pisiform contact centrally over the spinous process of the most painful level of the cervical spine by a registered and practicing health care practitioner (i.e. physiotherapist).

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-11-10
• Completion: 2024-11-12
• First posted: 2023-09-14
• Last updated: 2025-01-29

Locations

1 site across 1 country: Switzerland