Linking Physiological Responses to Clinical Outcomes Following Cervical

Status Recruiting

Clinical 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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Neck Pain

Clinical Trial Details

NCT number	NCT06036849
Study type	Interventional
Source	Balgrist University Hospital
Contact	Lindsay Gorrell, PhD
Phone	+41 44 510 73 82
Email	lindsaymary.gorrell@uzh.ch
Status	Recruiting
Phase	N/A
Start date	September 12, 2023
Completion date	July 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Linking Physiological Responses to Clinical Outcomes Following Cervical Spine Manipulation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms