Abstract
Objectives This feasibility study aimed to inform the development of a protocol for a single-blind randomised controlled trial (RCT) investigating the efficacy of OldPain2Go® for the treatment of chronic low back pain (CLBP).
Design Single arm feasibility study.
Setting One private physiotherapy practice.
Participants Twenty two individuals with CLBP were recruited and 15 completed the study providing full data sets (11 female, 4 male, mean age 49.3, range 18-71 years).
Intervention OldPain2Go®, a novel talking therapy for pain. Participants received up to two individual treatment sessions with one therapist.
Main Outcome Measures Pain (0-10 pain Numerical Rating Scale) and function (Roland Morris Disability Questionnaire, 0-24, higher score indicates poorer levels of function), measured before and after all sessions and at 3-week follow-up.
Results The study recruited to target, only one participant withdrew from the study (unrelated to the study) and there were no adverse events/reactions attributed to the intervention. Of 15 participants, five received one treatment session and 10 received two sessions. Improvements in pain and function were seen in all those who completed the study with average improvements above the pre-set minimal clinically important change.
Conclusions: Important methodological information was obtained, which will inform a future large-scale RCT of this intervention. As this was a feasibility study no claims about efficacy can be made. Future research to investigate the efficacy of this intervention is warranted.
Trial registration: ClinicalTrials.gov Identifier: NCT03804567
Contribution of the Paper
• OldPain2Go® is a new treatment for chronic pain which is growing in popularity but there is no scientific literature on its safety or efficacy.
• A large scale RCT of the efficacy and effectiveness of OldPain2Go® as an intervention for people with CLBP is warranted
Key words Chronic Pain; Pain Perception; Complementary Therapies; Low back pain; Feasibility Study
Design Single arm feasibility study.
Setting One private physiotherapy practice.
Participants Twenty two individuals with CLBP were recruited and 15 completed the study providing full data sets (11 female, 4 male, mean age 49.3, range 18-71 years).
Intervention OldPain2Go®, a novel talking therapy for pain. Participants received up to two individual treatment sessions with one therapist.
Main Outcome Measures Pain (0-10 pain Numerical Rating Scale) and function (Roland Morris Disability Questionnaire, 0-24, higher score indicates poorer levels of function), measured before and after all sessions and at 3-week follow-up.
Results The study recruited to target, only one participant withdrew from the study (unrelated to the study) and there were no adverse events/reactions attributed to the intervention. Of 15 participants, five received one treatment session and 10 received two sessions. Improvements in pain and function were seen in all those who completed the study with average improvements above the pre-set minimal clinically important change.
Conclusions: Important methodological information was obtained, which will inform a future large-scale RCT of this intervention. As this was a feasibility study no claims about efficacy can be made. Future research to investigate the efficacy of this intervention is warranted.
Trial registration: ClinicalTrials.gov Identifier: NCT03804567
Contribution of the Paper
• OldPain2Go® is a new treatment for chronic pain which is growing in popularity but there is no scientific literature on its safety or efficacy.
• A large scale RCT of the efficacy and effectiveness of OldPain2Go® as an intervention for people with CLBP is warranted
Key words Chronic Pain; Pain Perception; Complementary Therapies; Low back pain; Feasibility Study
| Original language | English |
|---|---|
| Pages (from-to) | 40-47 |
| Journal | Pain and Rehabilitation: The Journal of the Physiotherapy Pain Association |
| Volume | 2023 |
| Issue number | 53 |
| Publication status | Published - 18 Apr 2023 |