Neck PainNCT06036849
Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation
A study testing Spinal manipulation and Spinal mobilization in people with Neck Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Spinal manipulation and Spinal mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Sep 2023to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
- All contraindications to the application of spinal manipulation and mobilization (e.g. personal or family history of a connective tissue disorder, current use of anticoagulant therapy, history of recent surgery and/or neck trauma, facial or intra-oral anesthesia or paresthesia, visual disturbances, dizziness and/or vertigo). Such contraindications will be screened during the medical history and physical examination performed by a registered health care clinician (e.g. chiropractor). Any participant not meeting the inclusion and exclusion criteria will be excluded from the study. As in routine daily clinical practice at the Balgrist University Hospital Chiropractic Polyclinic, the ultimate decision whether it is appropriate to deliver an intervention to the participant (spinal manipulation and/or mobilization) will be determined by the clinician delivering the treatment. The investigator is responsible for coordinating adequate medical care if complications occur. Possible subsequent medical care is contingent on the nature of the complication and could range from referral to the on-site Chiropractic Department Polyclinic for follow-up treatment of muscle soreness to referral to the Emergency Department of the Balgrist University Hospital (not expected).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation: a Randomized Mechanistic Cross-over Trial
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.
Read the 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
- Being tested
- Spinal manipulation, Spinal mobilization
- Keywords
- Spinal Manipulation, Spinal Mobilization, Biomechanics, Physiological Responses, Clinical Outcomes
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationProcedure or surgery
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 mobilizationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Neck pain participants: spinal manipulation first | Experimental | Spinal manipulation will be delivered first (followed by spinal mobilization at 72 hours). Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately pre and immediately post intervention
Secondary outcomes (2)
Electromyographic root-mean-squared magnitude
Electromyographic root-mean-squared magnitudes are used to quantify the electrical activity of muscles. Bipolar sensors (Kendall) will be placed over specific portions of three muscles (sternocleidomastoid, upper trapezius and tibialis anterior) according to the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) guidelines. Larger root-mean-squared values indicate greater electrical activity of the muscle. Differences between pre and post-intervention resting values will be measured, allowing for a quantification of the electrical activity of the muscle. Additionally, the electrical activity of the muscle associated with spinal manipulation and mobilization will be measured during the intervention.
Measured: For 7 minutes pre-intervention, during the intervention (approximately 30 seconds) and for 7 minutes post-intervention
Change in heart rate variability
Heart rate variability measures the instantaneous change in heart rate. It is measured using a three-lead electrocardiogram protocol and a respiratory belt (ADInstruments). Larger variability in heart rate is reported to be associated with better health. Heart rate variability will be measured with the participant in 'quiet lying' pre and post-intervention.
Measured: Immediately pre and immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start12 Sep 2023
- Primary completion10 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, mechanistic, cross-over clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université du Québec à Trois-Rivières
- Responsible party
- Principal investigator, Schweinhardt Petra, Balgrist University Hospital
- Investigators
- Lindsay Gorrell, PhD, Principal investigator, University of Zürich and Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036849
- Sponsor's protocol ID
- CCRF Project
- Status last verified
- Mar 2024
- First submitted
- 24 Aug 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation: a Randomized Mechanistic Cross-over Trial
- ClinicalTrials.gov ID
- NCT06036849
- Acronym / sponsor ID
- CCRF Project
- Conditions
- Neck Pain
- Keywords
- Spinal Manipulation, Spinal Mobilization, Biomechanics, Physiological Responses, Clinical Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Université du Québec à Trois-Rivières
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, mechanistic, cross-over clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Neck pain participants: spinal manipulation first | Experimental | Procedure: Spinal manipulation, Procedure: Spinal mobilizationSpinal manipulation will be delivered first (followed by spinal mobilization at 72 hours). |
| Neck pain participants: spinal mobilization first | Experimental | Procedure: Spinal manipulation, Procedure: Spinal mobilizationSpinal mobilization will be delivered first (followed by spinal manipulation at 72 hours). |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal manipulationThe 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 or surgery | Neck pain participants: spinal manipulation first, Neck pain participants: spinal mobilization first |
| Spinal mobilizationThe 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). | Procedure or surgery | Neck pain participants: spinal manipulation first, Neck pain participants: spinal mobilization first |
Primary outcome
Patient global impression of change following treatment
Time frame: Immediately post intervention
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.
Change in numerical pain rating score
Time frame: Immediately pre and immediately post intervention
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.
Change in pressure pain threshold
Time frame: Immediately pre and immediately post intervention
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.
Change in active cervical spine range of motion
Time frame: Immediately pre and immediately post intervention
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.
2 secondary outcomes
Electromyographic root-mean-squared magnitude
Time frame: For 7 minutes pre-intervention, during the intervention (approximately 30 seconds) and for 7 minutes post-intervention
Change in heart rate variability
Time frame: Immediately pre and immediately post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Gorrell, PhD principal investigator
University of Zürich and Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal manipulation and Spinal mobilization in people with Neck Pain, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient global impression of change following treatment (time frame: Immediately post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.