TENS for Testicular Pain (ICO): A Randomized Controlled Trial

NCT04866784 | Completed FDA Device

• 1 other identifier: 202004356
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic Chronic Orchialgia (i.e., testicular pain) is a challenging condition to treat, with unresolved testicular pain leading to distress, diminished activities of daily living and decreased quality of life. Testicular Pain may be caused by a tumor, hernia, infection, trauma, vein compression, cysts, and/or postoperative or radiating pain, though is often times unknown. Non-pharmacologic, conservative pain reduction interventions include heat, ice, scrotal support, physical therapy, and/or counseling, and should often be used as first line of defense. More aggressive, invasive, and non-conservative medical treatment options include medications, nerve blocks, and/or surgery, each of which may be effective, but may be invasive and/or cause serious side effects. However, there is no standard of care for managing the testicular pain and many men do not respond to current biomedical or nonpharmacologic treatment options. Novel, non-invasive treatment options are needed for ICO to improve distress, daily living activities, and quality of life. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacologic intervention for acute and chronic pain. This treatment involves the application of electric current through the skin; it is safe, easy to use, and inexpensive. Despite the impact and distress associated with Testicular Pain, only one known study examined the efficacy of TENS for this condition. A 2018 double-blind, randomized controlled study of people with Testicular Pain reported that TENS improved pain and quality of life significantly more than the control condition (analgesia only). This 2018 study lacked a placebo control condition (i.e., unknown whether pain relief was due to the placebo effect, where knowing an intervention is happening leads to an expectation that pain will decrease, and therefore pain perception decreases independent of the intervention). Thus, the aim of this study is to examine the efficacy of TENS on Testicular Pain using a randomized, placebo-controlled design. The results of this study will be used to inform a larger, federally-funded study. i. Primary Aim: To assess the efficacy of TENS for Testicular Pain ii. Secondary Aim: To assess the feasibility of TENS for Testicular Pain iii. Third Aim: To assess the tolerability of TENS for Testicular Pain iii. To assess associations between dispositional pain catastrophizing on responsiveness to the TENS intervention.

Conditions

Pain Management

Keywords

Transcutaneous electric nerve stimulation; Idiopathic chronic orchialgia; Testicular Pain; Chronic Pain; Testicular; Scrotum

Outcome Measures

Primary Outcomes (2)

• Change in Short-Form McGill Pain Questionnaire (MPQ) Pain Scores

  Qualitative (e.g.sharp, distressing) and quantitative pain scales. Quantitative pain scale consists of 15 descriptors (11 sensory, 4 affective) which are rated on an intensity scale of 0 = none, 1=mild, 2=moderate, 3=severe.

  This outcome measure will be used within 10 minutes of the start of each visit (right before TENS is applied) and 30 minutes after TENS is applied (within visit MPQ change) to assess the within visit change in MPQ pain.

• Change in 10-point Numeric Pain Intensity Rating Scale (NRS) pain scores

  Quantitative pain scale ranging from 0 (no pain) to 10 (worst pain imaginable)

  This outcome measure will be used within 10 minutes of the start of each visit (right before TENS is applied) and 30 minutes after TENS is applied (within visit NRS change) to assess the within visit change in NRS pain.

Secondary Outcomes (1)

• Pain Catastrophizing Scale (PCS)

  This outcome measure will be used at the start of the study (after they consent; baseline). PCS scores range from 0-52 and higher scores mean worse catastrophizing. A decrease in PCS scores is a good outcome.

Study Arms (3)

High Sensation TENS

EXPERIMENTAL

Active TENS is delivered for 30mins at a frequency of 100 Hz and pulse duration of 100μsec using the EMPI Select TENS unit (calibrated using an oscilloscope prior to study). The intensity will be increased until patients feel a "maximally strong but comfortable sensation" to ensure an analgesic effect.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Low Sensation TENS

PLACEBO COMPARATOR

Placebo TENS parameters will be identical to Active TENS (100 Hz and 100 μsec), but a novel placebo TENS unit, previously tested and validated will be used (Rakel et al., 2010). The placebo device provides a current for 30sec and ramps off over 15sec to zero output. An indicator light remains on so it appears to the subject that the unit is still producing current. This unit has demonstrated nearly 100% blinding of investigators such that the investigator applying the TENS is unable to distinguish between the active and the placebo unit; approximately \~50% of subjects are successfully blinded using this unit.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

No Treatment Control

NO INTERVENTION

The No Treatment Control includes application of TENS electrodes identical to the other 2 conditions, but the unit remains off. This condition will control for potential effects of repeat testing and any placebo effect.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacologic intervention for acute and chronic pain. This treatment involves the application of electric current through the skin; it is safe, easy to use, and inexpensive

High Sensation TENS; Low Sensation TENS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Only individuals with at least one descended testicle.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years to 99;
• Diagnosis of Idiopathic Chronic Orchialgia (ICO)
• English Speaking (does not need to be native language)

You may not qualify if:

• Pain intensity rating less than 2/10 at time of first session
• Inability to read or write
• Inability to follow directions
• Contraindications for TENS (Nickel allergy, pacemaker, open wound in TENS application area)
• \. TENS use in last 5 years.

Sponsors & Collaborators

• Jennifer E. Lee: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (9)

• Levine L. Chronic orchialgia: evaluation and discussion of treatment options. Ther Adv Urol. 2010 Oct;2(5-06):209-14. doi: 10.1177/1756287210390409.

  PMID: 21789076 BACKGROUND

• Granitsiotis P, Kirk D. Chronic testicular pain: an overview. Eur Urol. 2004 Apr;45(4):430-6. doi: 10.1016/j.eururo.2003.11.004.

  PMID: 15041105 BACKGROUND

• Belanger GV, VerLee GT. Diagnosis and Surgical Management of Male Pelvic, Inguinal, and Testicular Pain. Surg Clin North Am. 2016 Jun;96(3):593-613. doi: 10.1016/j.suc.2016.02.014.

  PMID: 27261797 BACKGROUND

• Kavoussi PK, Costabile RA. Orchialgia and the chronic pelvic pain syndrome. World J Urol. 2013 Aug;31(4):773-8. doi: 10.1007/s00345-013-1092-5. Epub 2013 May 5.

  PMID: 23645410 BACKGROUND

• Masarani M, Cox R. The aetiology, pathophysiology and management of chronic orchialgia. BJU Int. 2003 Mar;91(5):435-7. doi: 10.1046/j.1464-410x.2003.04094.x. No abstract available.

  PMID: 12603394 BACKGROUND

• Tojuola B, Layman J, Kartal I, Gudelogul A, Brahmbhatt J, Parekattil S. Chronic orchialgia: Review of treatments old and new. Indian J Urol. 2016 Jan-Mar;32(1):21-6. doi: 10.4103/0970-1591.173110.

  PMID: 26941490 BACKGROUND

• Lee JE, Anderson CM, Perkhounkova Y, Sleeuwenhoek BM, Louison RR. Transcutaneous Electrical Nerve Stimulation Reduces Resting Pain in Head and Neck Cancer Patients: A Randomized and Placebo-Controlled Double-Blind Pilot Study. Cancer Nurs. 2019 May/Jun;42(3):218-228. doi: 10.1097/NCC.0000000000000594.

  PMID: 29649082 BACKGROUND

• Osiri M, Welch V, Brosseau L, Shea B, McGowan J, Tugwell P, Wells G. Transcutaneous electrical nerve stimulation for knee osteoarthritis. Cochrane Database Syst Rev. 2000;(4):CD002823. doi: 10.1002/14651858.CD002823.

  PMID: 11034768 BACKGROUND

• Tantawy SA, Kamel DM, Abdelbasset WK. Does transcutaneous electrical nerve stimulation reduce pain and improve quality of life in patients with idiopathic chronic orchialgia? A randomized controlled trial. J Pain Res. 2017 Dec 27;11:77-82. doi: 10.2147/JPR.S154815. eCollection 2018.

  PMID: 29343983 BACKGROUND

MeSH Terms

Conditions

Agnosia; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Amy M Pearlman, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The experimenter and subject will be blinded to the treatment conditions. A second experimenter will administer the Active or Placebo TENS, or the Control to ensure appropriate blinding (to ensure no bias from knowing which TENS condition is given at each visit).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Model Details: The study is a prospective, randomized, double-blinded and placebo-controlled crossover design (all participants complete each of the 3 conditions) with randomization to: 1) Active TENS; 2) Placebo TENS; or 3) No Treatment Control. Each subject will receive the 3 TENS treatments in randomized order (one visit per week in three separate weeks). The visits do not have to take place in three consecutive weeks (will depend on participant scheduling preferences), but all three visits must take place within one year

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: April 30, 2021
• Study Start: December 23, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)