Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain (PSWT)
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|ClinicalTrials.gov Identifier: NCT03828864|
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Device: Pulsed Shortwave Therapy Device: Placebo Pulsed Shortwave Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Active medical device and and identical dummy device (placebo) that does not emit the pulsed shortwave signal.|
|Official Title:||Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Active Comparator: Active Pulsed Shortwave therapy
Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.
Device: Pulsed Shortwave Therapy
Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Other Name: ActiPatch
Placebo Comparator: Placebo Pulsed Shortwave therapy
Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.
Device: Placebo Pulsed Shortwave Therapy
Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
Other Name: Placebo ActiPatch
- Brief Pain Inventory (BPI) Short Form [ Time Frame: 30 days ]
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.
Question answers are complied into two categories:
- Pain severity is 0 - 10, with 10 being worst pain possible
- Pain inference score is 0 - 10, with 10 being worst possible pain inference
- Central Sensitisation Inventory - short form (CSI-9) [ Time Frame: 30 days ]
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
- Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance [ Time Frame: 30 days ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828864
|Contact: Graeme Campbell||(02) email@example.com|
|Contact: Arun Aggarwal, Prof||02 9515 firstname.lastname@example.org|
|Principal Investigator:||Graeme Campbell||Royal Prince Alfred Hospital, Sydney, Australia|
|Study Chair:||Arun Aggarwal, Professor||Royal Prince Alfred Hospital, Sydney, Australia|