Pain
Conditions
Keywords
Pain, Bone marrow aspiration, trephine biopsy
Brief summary
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
Detailed description
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.
Interventions
DEVICETrans-cutaneous Electrical Nerve Stimulation (TENS)
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).
DRUGStandard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)
All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)
Sponsors
Torbay and South Devon NHS Foundation Trust
University Hospital Plymouth NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * Participants are those medical patients seen in the haematology outpatients clinic for whom a bone-marrow trephine biopsy is deemed necessary either for diagnosis, staging or disease monitoring purposes. Participants are either new patients or routine follow ups. * Participant is able (in the Investigators opinion) and willing to comply with all study requirements. * Participant is willing to allow his or her General Practitioner to be notified of participation in the study.
Exclusion criteria
* Any known adverse reaction to high-frequency TENS or electrode gel pads * Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | Post procedure and 24 hours | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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) | 35 |
| 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 | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | TENS Intervention | TENS Placebo Comparator | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 69 years | 69 years |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 32 Participants |
| Sex: Female, Male Male | 21 Participants | 17 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
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.
Time frame: Post procedure and 24 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TENS Intervention | Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | Mean Pain Score immediately post procedure | 5.6 Numerical Pain Severity Scale (0-10) |
| TENS Intervention | Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | Mean pain score 24 hours post procedure | 1.9 Numerical Pain Severity Scale (0-10) |
| TENS Placebo Comparator | Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | Mean Pain Score immediately post procedure | 5.7 Numerical Pain Severity Scale (0-10) |
| TENS Placebo Comparator | Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain | Mean pain score 24 hours post procedure | 1.9 Numerical Pain Severity Scale (0-10) |