Oxytocin in Chronic Neck and Shoulder Pai

Phase 2

Completed

• Conditions: Musculoskeletal neck and/or shoulder pain that has lasted for a minimum of 12 months; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616000532404
• Lead Sponsor: Dr Melita Giummarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Chronic pain participants: English speaking patients aged 18-60 living with musculoskeletal neck and/or shoulder pain that has lasted for at least twelve months and who have been constant in their pain and symptoms for the last 6 months.

Healthy volunteers will be recruited as control participants and will be subject to the same inclusion/exclusion criteria as the chronic pain participants, with the exception of the presence of the neck and/or shoulder pain.

Exclusion Criteria

Any form of current active treatment (e.g. physiotherapy, manual therapy); past or current history of medical conditions known to affect autonomic functioning (e.g. diabetes, dysthyroidism); past or current history of cancer or other malignancies, asthma or any other chronic respiratory condition, psychological or psychiatric conditions (identified as at risk” of moderate depression, anxiety, or suicidal ideation (as indicated by scores higher than 20 on the Beck Depression Inventory II (BDI-II), scores greater than 15 on the Beck Anxiety Inventory (BAI), or a score of 2 or more on item 9 of the BDI-II)) , alcohol or substance abuse disorders, hypertension or heart disease, neurodegenerative diseases, colour blindness, moderate-severe traumatic brain injury; medications known to affect the autonomic nervous system (e.g. beta blockers, selective serotonin reuptake inhibitors, opioids, benzodiazepines, tricyclic antidepressants, anticholinergics, antiarrhythmics); pregnancy or breastfeeding; any known allergies; incapable of walking; bedridden.

Healthy volunteers will be recruited as control participants and will be subject to the same inclusion/exclusion criteria as the chronic pain participants, with the exception of the presence of the neck and/or shoulder pain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum change in heart rate measured by a 5 lead electrocardiograph system between anticipation and stimulus delivery periods of pain anxiety paradigm. The heat stimuli are delivered by device that can deliver a controlled amount of heat to the skin to cause a burning sensation.[Heart rate is monitored continuously during the completion of Task 1 and Task 4 in both testing sessions.];Maximum change in skin conductance measured by skin conductance finger electrodes between anticipation and stimulus delivery periods of pain anxiety paradigm. The heat stimuli are delivered by device that can deliver a controlled amount of heat to the skin to cause a burning sensation.[Skin conductance is monitored continuously during the completion of Task 1 and Task 4 in both testing sessions.];Subjective ratings of anticipatory anxiety using an 11-point numerical rating scale (NRS) in response to the presentation of a visual cue in pain anxiety paradigm.[Measured in 12 seconds following stimulus delivery.]