Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation
- Conditions
- Neck Pain
- Interventions
- Procedure: Spinal manipulationProcedure: Spinal mobilization
- Registration Number
- NCT06036849
- Lead Sponsor
- Balgrist University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Neck pain participants: spinal manipulation first Spinal mobilization Spinal manipulation will be delivered first (followed by spinal mobilization at 72 hours). Neck pain participants: spinal mobilization first Spinal manipulation Spinal mobilization will be delivered first (followed by spinal manipulation at 72 hours). Neck pain participants: spinal mobilization first Spinal mobilization Spinal mobilization will be delivered first (followed by spinal manipulation at 72 hours). Neck pain participants: spinal manipulation first Spinal manipulation Spinal manipulation will be delivered first (followed by spinal mobilization at 72 hours).
- Primary Outcome Measures
Name Time Method Change in pressure pain threshold 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 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.
Change in numerical pain rating score 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.
Patient global impression of change following treatment 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.
- Secondary Outcome Measures
Name Time Method Change in heart rate variability Immediately pre and immediately post intervention 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.
Electromyographic root-mean-squared magnitude For 7 minutes pre-intervention, during the intervention (approximately 30 seconds) and for 7 minutes post-intervention 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.
Trial Locations
- Locations (1)
Balgrist University Hospital
🇨ðŸ‡Zurich, Switzerland