Newton-Wellesley Hospital- Ambulatory Pain Service
Newton, Massachusetts, 02459, United States
NCT Number: NCT04865263
The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.
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Notify Me18 year and older
All sexes
Observational
Newton, Massachusetts, 02459, United States
Chronic pain is today an increasing health problem in both Europe and US, with an estimation of about 90 million people affected in Europe (Breivik, H. et al., 2006) and 100 million people in US (Relieving Pain in America, IOM Report 2011), or 20-30% of the adult population around the world. Chronic pain is defined as a condition that lasts for at least three to six months, after the normal healing period of an injury. Medical interventions offered in clinics around the globe are unfortunately not giving the results needed to give back the quality of life the patients had prior to the onset of the pain. The treatments offered today do sometimes reduce pain, but the effect is minor, and new treatment regimens are needed (Relieving Pain in America, 2011). Recent quality assurance registry measurements in Sweden has shown that patient taken part of multi modal treatment regimens, such as the acceptance and commitment therapy, (ACT) show that less then 40% of the patients have a decline in the pain level of 1 level on the VAS scale, 55% has no effect and 9 % has an increased level of pain after going through the program (Nationel Register for Pain Rehabilitation, Sweden 2017) The study objective is to evaluate how the use of a digital pain coach, based on artificial intelligence that improves the self-management of pain will decrease the pain interference and thereby increase QoL among chronic pain patients, as measured by PROMIS pain interference 6a. We will here compare the improvement of quality of life by a decrease in pain interference, measured by PROMIS, in patients who follow their traditional treatment plan provided by the Pain Clinic with the addition of using a web application for increased self management of pain. The theory behind the study and the development of the device is supported by previously known data, showing that self-management has an effect and is important to the treatment by helping patients to believe in their own capacity to control their pain.
The present investigation aims at exploring the effect of including digital tool as an add on to standard treatment and rehabilitation and will measure the effect it has on:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
18 years of age
Exclusion criteria
Self management digital tool for chronic pain
Time frame: 6 and 12 weeks from baseline
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a . Measure of the amount of interference pain causes in life; range 6-30; higher is worse
Time frame: 6 and 12 weeks from baseline
Change from Baseline in the 7 day average pain intensity. Measured by NRS using an 11-point Pain Intensity Numerical Rating Scale (NRS) (0=no pain, 10=pain as bad as you can imagine)
Time frame: 6 and 12 weeks from baseline
Change from baseline in physical function, measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Physical function 10a.
Measure of the impact of a condition on physical function; range 4-20; higher is worse
Time frame: 6 and 12 weeks from baseline
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression 4a.
Measures the extent to which patients experience depressive symptoms over the past 7 days. Raw scores range from 4-20 with lower scores representing less endorsement of depression
Time frame: 6 and 12 weeks from baseline
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety 4.
Measures the extent to which patients experience anxiety symptoms over the past 7 days. Raw scores range from 4-20 with lower scores representing less endorsement of anxiety.
Time frame: 6 and 12 weeks from baseline
The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing The theoretical range of the instrument is between 0 and 52, with low scores indicating low catastrophizing, and high values showing high catastrophizing.
Time frame: 6 and 12 weeks from baseline
Chronic Pain Acceptance Questionnaire-8 (CPAQ-8) CPAQ-8 is an 8-question survey that measures the level of patient acceptance of pain. The scale ranges from 0-48 and where a higher scores corresponds to greater acceptance of pain.
Lund University
Other
Digital Self-Management of Chronic Pain
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