Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation

NCT ID: NCT06036849

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2024-11-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neck pain participants: spinal manipulation first

Spinal manipulation will be delivered first (followed by spinal mobilization at 72 hours).

Group Type: EXPERIMENTAL

Spinal manipulation

Intervention Type: PROCEDURE

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.

Spinal mobilization

Intervention Type: PROCEDURE

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).

Neck pain participants: spinal mobilization first

Spinal mobilization will be delivered first (followed by spinal manipulation at 72 hours).

Group Type: EXPERIMENTAL

Spinal manipulation

Intervention Type: PROCEDURE

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.

Spinal mobilization

Intervention Type: PROCEDURE

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).

Healthy controls

Participants will attend a single session and no intervention will be performed but all experimental procedures will be identical to those occurring in the neck pain cohort. Measurements in individuals without neck pain are necessary for the assessment of potential baseline differences in the outcomes of interest between the patient cohort (with neck pain) and those without neck pain. Without this information, it is not possible to determine if the measured responses to spinal manipulation are due to the intervention or, systematic differences in the baseline outcomes of interest in the symptomatic cohort.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

All participants:

• 18-65 years of age
• English and/or French and/or German proficiency (to guarantee proper understanding of instructions and informed consent)
• Provision of informed consent

People with neck pain:

• Mechanical neck pain located inferior to the superior nuchal line and inferior border of the mandible and superior to the superior border of the clavicle, suprasternal notch and scapular spines bilaterally
• Neck pain of ≥ 12 weeks duration
• Neck pain not associated with an identified pathological cause
• Who have not received treatment for their neck pain (e.g. spinal manipulation, spinal mobilization, massage etc) in the previous 2 weeks

Exclusion Criteria

All participants:

• Unable to provide informed consent (e.g. due to language difficulties)
• Any neurological condition
• Any major medical or psychiatric condition (e.g. cardiovascular disease, diabetes, autoimmune disorders, major depressive disorder)
• Conditions and/or medications that could affect heart rate variability signals (e.g. hypertension, obesity (body mass index > 30), the current use of pain medications, steroids, antidepressants and/or β-blockers)
• Any chronic pain condition other than neck pain (e.g. low back pain)
• Pregnancy (all females will be asked verbally if there is a chance they are pregnant during screening)

People without neck pain:

• Acute pain
• Neck pain (> 3 consecutive days) in the last year

People with neck pain:

• Neck pain that does not originate from the cervical spine
• Who have received treatment for their neck pain (e.g. spinal manipulation, spinal mobilization, massage etc) in the previous 2 weeks
• Who have taken medication within the past 24 hours prior to the first visit and during their participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: collaborator

Balgrist University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Schweinhardt Petra

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsay Gorrell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zürich and Balgrist University Hospital

Locations

Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

CCRF Project

Identifier Type: -

Identifier Source: org_study_id