N/A
N=70
Does Trans-Cutaneous Electrical Nerve Stimulation (TENS) Alleviate The Pain Experienced During Bone Marrow Sampling?
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02005354 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain — 5.6; 5.7; 1.9; 1.9 Numerical Pain Severity Scale (0-10)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trans-cutaneous Electrical Nerve Stimulation (TENS) (Device); Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital Plymouth NHS Trust
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain |
5.6; 5.7; 1.9; 1.9 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02005354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.