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

September 27, 2019 updated by: University Hospital Plymouth NHS Trust

Does Trans-Cutaneous Electrical Nerve Stimulation (TENS) Alleviate The Pain Experienced During Bone Marrow Sampling in Addition to Standard Techniques?A Randomised, Double-Blinded, Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Plymouth Hospitals Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trans-cutaneous Electrical Nerve Stimulation (TENS)

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)
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).
Drug: Standard 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)
Placebo Comparator: Trans-cutaneous Electric Nerve Stimulation (TENS)

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)
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).
Drug: Standard 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 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.
Post procedure and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Plymouth NHS Trust

Collaborators

Torbay and South Devon NHS Foundation Trust

Investigators

  • Study Director: Simon AJ Rule, MBChB, MPhil, University Hospital Plymouth NHS Trust
  • Principal Investigator: Sarah L Poplar, MB ChB, University Hospital Plymouth NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/P/168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Trans-cutaneous Electrical Nerve Stimulation (TENS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe