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| Name | Class |
|---|---|
| Torbay and South Devon NHS Foundation Trust | OTHER |
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The approach of this study will be to answer the question does high-frequency stimulation Trans-Cutaneous Electrical Nerve Stimulation (TENS) alleviate the pain experienced during the bone marrow sampling procedure in addition to the standard analgesia given (ie. local anaesthetic with or without inhaled nitrous oxide).
Null hypothesis: TENS does not alleviate the pain experienced during the bone marrow sampling procedure in addition to the standard analgesia given
Patients in whom a bone marrow biopsy is planned will be randomised to one of two groups - a control-TENS group where the TENS machine will be set at the lowest sensory threshold and an intervention-TENS group where the TENS machine will be set at a recognised analgesic level (>50 Hertz (Hz) and below the pain threshold for the patient) (Bennett et al. 2011). The identity of the TENS type will be concealed from both the patient and the doctor performing the biopsy. The primary outcome will be pain and this will be recorded by the patient immediately after the procedure using a validated numerical scale (0-10). All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide).
The benefit of this study is to establish whether or not TENS can benefit patients as an additional, safe, non-invasive and inexpensive method of pain relief during this frequently painful procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans-cutaneous Electrical Nerve Stimulation (TENS) | Active Comparator | The Intervention-TENS group will have 2 electrodes applied proximal to the painful area along neuro-anatomical distribution (electrode-one placed 5cm superior and 2cm medial to the posterior superior iliac spine and electrode-two placed 5cm medial to the posterior superior iliac spine) in the same way as the control-TENS group. The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a "strong but comfortable sensation". From previous studies, this is likely to be 50-110Hz. The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study. All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) |
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| Trans-cutaneous Electric Nerve Stimulation (TENS) | Placebo Comparator | Patients in the CT group will have 2 gel-electrodes applied proximal to the sampling area (usually the right posterior superior iliac crest). The Control-TENS device will be identical in appearance to the "Intervention-TENS" device with a functioning display panel. The concealed electrical parameter in this group will be titrated to and set at the sensory detection. All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-cutaneous Electrical Nerve Stimulation (TENS) | Device | Patients in whom a bone marrow biopsy is planned will be randomised to one of two groups - a Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient). |
| Measure | Description | Time Frame |
|---|---|---|
| Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | To establish the effect of high-frequency stimulation TENS on the pain experienced by patients undergoing a bone-marrow biopsy, using standard technique with local anaesthetic. The perception of pain will be measured using a pain scale directly after and 24 hours after bone-marrow sampling in patients randomly allocated and blinded to the use of intervention-TENS (IT) or control-TENS (CT) in addition to local anaesthesia. | Post procedure and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon AJ Rule, MBChB, MPhil | University Hospital Plymouth NHS Trust | Study Director |
| Sarah L Poplar, MB ChB | University Hospital Plymouth NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plymouth Hospitals NHS Trust | Plymouth | Devon | PL6 8DH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21435786 | Background | Bennett MI, Hughes N, Johnson MI. Methodological quality in randomised controlled trials of transcutaneous electric nerve stimulation for pain: low fidelity may explain negative findings. Pain. 2011 Jun;152(6):1226-1232. doi: 10.1016/j.pain.2010.12.009. Epub 2011 Mar 23. | |
| 25759407 | Derived | Tucker DL, Rockett M, Hasan M, Poplar S, Rule SA. Does transcutaneous electrical nerve stimulation (TENS) alleviate the pain experienced during bone marrow sampling in addition to standard techniques? A randomised, double-blinded, controlled trial. J Clin Pathol. 2015 Jun;68(6):479-83. doi: 10.1136/jclinpath-2015-202908. Epub 2015 Mar 10. |
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70 patients were randomised, thirty five patients received TENS impulses at a strong but comfortable amplitude (intervention group) and 35 patients received TENS impulses just above the sensory threshold (control group)
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| ID | Title | Description |
|---|---|---|
| FG000 | TENS Intervention | The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a "strong but comfortable sensation". From previous studies, this is likely to be 50-110Hz. The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study. All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) | Drug | All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) |
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| FG001 | TENS Placebo Comparator | Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient). Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain |
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| NOT COMPLETED |
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Patients were >18 years & required a bone marrow for diagnosis, staging or disease monitoring. Patients with known adverse reaction to TENS or electrode gel pads and patients with a cardiac pacemaker or implantable defibrillator in-situ were excluded from the trial. There was no upper age limit.
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| ID | Title | Description |
|---|---|---|
| BG000 | TENS Intervention | The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a "strong but comfortable sensation". From previous studies, this is likely to be 50-110Hz. The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study. All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) |
| BG001 | TENS Placebo Comparator | Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient). Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | To establish the effect of high-frequency stimulation TENS on the pain experienced by patients undergoing a bone-marrow biopsy, using standard technique with local anaesthetic. The perception of pain will be measured using a pain scale directly after and 24 hours after bone-marrow sampling in patients randomly allocated and blinded to the use of intervention-TENS (IT) or control-TENS (CT) in addition to local anaesthesia. | Posted | Mean | 95% Confidence Interval | Numerical Pain Severity Scale (0-10) | Post procedure and 24 hours |
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11 months
As per protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TENS Intervention | The concealed electrical parameter in this group will be within the therapeutic window, that is, well above the sensory detection threshold but below the pain threshold giving a "strong but comfortable sensation". From previous studies, this is likely to be 50-110Hz. The device will be activated prior to entry into the treatment room and 2 minutes before administration of local anaesthetic and for 2 minutes after removal of the biopsy needle. This will cover the expected duration of pain as assessed in the pilot study. All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) | 0 | 35 | 0 | 35 | 0 | 35 |
| EG001 | TENS Placebo Comparator | Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient). Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide): All patients will receive standard pain | 0 | 35 | 0 | 35 | 0 | 35 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Tucker | Plymouth Hospitals NHS Trust | 01752 432595 | david.tucker1@nhs.net |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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