Does Trans-Cutaneous Electrical Nerve Stimulation (TENS) Alleviate The Pain Experienced During Bone Marrow Sampling?

NCT02005354 | Completed Results

• 1 other identifier: 13/P/168
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

Pain; Bone marrow aspiration; trephine biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Device: Trans-cutaneous Electrical Nerve Stimulation (TENS); Drug: Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)

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)

Device: Trans-cutaneous Electrical Nerve Stimulation (TENS); Drug: Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)

Interventions

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).

Trans-cutaneous Electric Nerve Stimulation (TENS); Trans-cutaneous Electrical Nerve Stimulation (TENS)

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)

Trans-cutaneous Electric Nerve Stimulation (TENS); Trans-cutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead
• Torbay and South Devon NHS Foundation Trust: collaborator

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 21435786 BACKGROUND

• 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.

  PMID: 25759407 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr David Tucker
• Organization: Plymouth Hospitals NHS Trust

david.tucker1@nhs.net

01752 432595

Study Officials

• Simon AJ Rule, MBChB, MPhil

  University Hospital Plymouth NHS Trust

  STUDY DIRECTOR

• Sarah L Poplar, MB ChB

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 8, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Locations

GB (1)