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| Name | Class |
|---|---|
| Royal Prince Alfred Hospital, Sydney, Australia | OTHER |
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This study aims to test the efficacy of the ActiPatch® device by means of a randomized double blind controlled trial in a convenience sample of chronic low back pain patients at RPAH pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.
This study aims to test the efficacy of the ActiPatch® device by means of a randomised double blind controlled trial in a convenience sample of chronic low back pain patients at Royal Prince Alfred Hospital (RPAH) pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Pulsed Shortwave therapy | Active Comparator | Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain. |
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| Placebo Pulsed Shortwave therapy | Placebo Comparator | Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Shortwave Therapy | Device | Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) Short Form | The BPI-SF is a questionnaire - self-administered or by interview - that assesses both pain intensity and pain interference in common aspects of one's life. It has reliability & validity across cultural and language groups & is one of the standard measures used by the national Electronic Persistent Pain Outcomes Collaboration (ePPOC) that collates data from various Pain Management Centres to evaluate outcomes in pain clinics Australia wide. Scoring Question answers are complied into two categories:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Central Sensitisation Inventory - short form (CSI-9) | Central Sensitisation (CS) is thought to be one underlying mechanism for the prevalence of chronic pain and the ActiPatch® device is believed to reduce central sensitization. Use of the CSI-9 will be used to assess the extent to which central sensitization is present in the study cohort and if use of the device produces a change in CS. This will then allow appraisal of the role of central sensitization in any outcomes achieved. Scoring, scores are totaled from the assessment Five severity levels (subclinical = 0-29, mild = 30-39, moderate = 40-49, severe = 50-59, and severe = 60-100) central sensitization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graeme Campbell | Contact | (02) 95159016 | graeme.campbell1@health.nsw.gov.au | |
| Arun Aggarwal, Prof | Contact | 02 9515 9870 | arun.a@sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Graeme Campbell | Royal Prince Alfred Hospital, Sydney, Australia | Principal Investigator |
| Arun Aggarwal, Professor | Royal Prince Alfred Hospital, Sydney, Australia | Study Chair |
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Active medical device and and identical dummy device (placebo) that does not emit the pulsed shortwave signal.
| Placebo Pulsed Shortwave Therapy | Device | Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day |
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| 30 days |
| Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance | The interaction between sleep disturbance and chronic pain is widely reported in the literature, and is thought to be a two way interaction. Use of the PSQ-3 will be used to assess the extent to which perceived sleep disturbance is present in the study cohort and if use of the ActiPatch® device is associated with a change in sleep quality. Addressing sleep quality may help to treat chronic pain including LBP and thereby have clinical treatment applications. Scoring 0-30, 0 no sleep disturbance and 30 worst sleep disturbance Three visual analog scales of 0-10 | 30 days |