Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation

NCT06036849 | Completed

• 1 other identifier: CCRF Project
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

Spinal Manipulation; Spinal Mobilization; Biomechanics; Physiological Responses; Clinical Outcomes

Outcome Measures

Primary Outcomes (4)

• Patient global impression of change following treatment

  The self-report measure patient global impression of change reflects a patient's belief about the efficacy of treatment. It is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. It is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." Lower scores indicate better outcomes.

  Immediately post intervention

• Change in numerical pain rating score

  The numerical pain rating score is an 11-point pain scale, with 0 representing no pain and 10 representing the most intense pain tolerable. Participants are asked to rate their current pain on this scale. Larger change scores from pre to post-intervention indicate a greater reduction of pain.

  Immediately pre and immediately post intervention

• Change in pressure pain threshold

  Pressure pain thresholds are measured using an algometer (JTECH medical). The participant is instructed to say 'now' or 'stop' immediately when the sensation of pressure changes to pain. Lower values indicate a lower pain threshold and larger differences between pre and post-intervention measurements indicates greater changes in pain perception. Pressure pain thresholds will be performed bilaterally over the mastoid insertion of the sternocleidomastoid, the mid-belly of the upper trapezius and the upper third of the tibialis anterior three times, with the average used for statistical comparisons.

  Immediately pre and immediately post intervention

• Change in active cervical spine range of motion

  Active cervical spine range of motion is measured using a digital inclinometer (JTECH medical). The participant will be asked to move their head from a neutral position in a specified direction (i.e. flexion, extension, lateral flexion to both sides and rotation to both sides) as far as they are able. These movements will be performed (in each direction) three times, with the average used for statistical comparisons. Larger increases from pre to post-intervention indicate greater improvement in the participant's active range of motion.

  Immediately pre and immediately post intervention

Secondary Outcomes (2)

• Electromyographic root-mean-squared magnitude

  For 7 minutes pre-intervention, during the intervention (approximately 30 seconds) and for 7 minutes post-intervention

• Change in heart rate variability

  Immediately pre and immediately post intervention

Study Arms (3)

Neck pain participants: spinal manipulation first

EXPERIMENTAL

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

Procedure: Spinal manipulation; Procedure: Spinal mobilization

Neck pain participants: spinal mobilization first

EXPERIMENTAL

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

Procedure: Spinal manipulation; Procedure: Spinal mobilization

Healthy controls

NO INTERVENTION

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.

Interventions

Spinal manipulation 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.

Neck pain participants: spinal manipulation first; Neck pain participants: spinal mobilization first

Spinal mobilization 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 manipulation first; Neck pain participants: spinal mobilization first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead
• Université du Québec à Trois-Rivières: collaborator

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Lindsay Gorrell, PhD

  University of Zürich and Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to treatment allocation. It will not be possible to blind participants with respect to treatment allocation. However, participants will be blinded to the study hypothesis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Randomized, mechanistic, cross-over clinical trial.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 14, 2023
• Study Start: September 12, 2023
• Primary Completion: November 10, 2024
• Study Completion: November 12, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)