Somatosensory Stimulation in Knee Osteoarthritis

NCT02854176 | Unknown Phase 2

• 1 other identifier: Somatosensory stimulation
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Worldwide, 9.6% of men and 18% of women aged over 60 years suffer from osteoarthritis (OA), most of which involve the knee. Within the OA patient population, 80% of the OA patients have limitations of movement, and 25% cannot perform the majority of their daily activities (WHO). Some of these symptoms contribute to arthrogenic muscle inhibition (AMI), a reflexive decrease in motor output to the muscles surrounding the affected joint. AMI is characterized by abnormal afferent information transmitted to the central nervous system, resulting in altered afferent feedback to the quadriceps motoneurons (MN) which in turn results in reduced excitability of that particular pool. The altered afferent input is suggested to stem from stimulation of mechanoreceptors, via joint effusion or excessive movements, nociceptors as a response to pain, or loss of joint receptors (Palmieri-Smith et al., 2009). Although the evidence concerning the role of the central nervous system is scarce, pre- and postsynaptic spinal mechanisms directly affecting alpha-MNs seem affected. Dysfunction of γ-loops also seems to be involved (Konishi et al., 2002). These mechanisms together result in AMI that manifests through aberrations in voluntary quadriceps torque, force control, and reflex excitability often measured by the H-reflex (Hopkins et al., 2000). Besides the evident role of motor efferents, sensory afferents also influence motor control (Gentilucci et al., 1997) and poor proprioceptive function is predictive of poor chair-stand performance (Sharma et al., 2003). Reduction of the sensory deficits could potentially increase motor function in knee OA. The present study aims to evaluate whether low-intensity peripheral electrical nerve stimulation, a form of increasing afferent input, could potentially improve OA patients' motor function. The most limiting factor in OA patients, however, is pain, experienced at rest and during movement. Although previous paradigms used high-frequency stimulation and the lack of physiological explanations concerning pain reductions after peripheral electrical nerve stimulation, it is possible that reductions in experienced pain are mediated by reduced analgesia, i.e., decreased excitability of nociceptive neurons.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Mean absolute deviation from a preprogrammed template during target tracking with the injured knee

  Change from before to after 60 minutes of somatosensory electrical stimulation applied to the femoral nerve

Secondary Outcomes (1)

• Quadriceps force accuracy and steadiness of the injured leg during isometric force at 50 and 100 Newton

  Change from before to after 60 minutes of somatosensory electrical stimulation applied to the femoral nerve

Study Arms (2)

Somatosensory electrical stimulation

EXPERIMENTAL

Procedure: Somatosensory electrical stimulation

Control

SHAM COMPARATOR

Procedure: Control

Interventions

Somatosensory electrical stimulation PROCEDURE

Somatosensory electrical stimulation

Control PROCEDURE

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 45 years.
• Unilateral symptomatic KOA.
• Patient in waitlist at the Schulthess Clinic for knee arthroplasty.
• Patient has mild to average pain levels
• Living place: Canton of Zurich or neighbouring Cantons.
• Signed written informed consent.

You may not qualify if:

• Symptomatic OA in lower extremity joints other than the knee.
• Bilateral symptomatic KOA.
• Usage of walking aids.
• Surgery to the lower limbs in the prior 12 months.
• BMI \>35 kg/m2.
• Disorders that affect visuomotor function.

Sponsors & Collaborators

• Menno Veldman: lead
• Schulthess Klinik: collaborator

Related Publications (24)

• Celnik P, Hummel F, Harris-Love M, Wolk R, Cohen LG. Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Arch Phys Med Rehabil. 2007 Nov;88(11):1369-76. doi: 10.1016/j.apmr.2007.08.001.

  PMID: 17964875 BACKGROUND

• Courtney CA, O'Hearn MA, Hornby TG. Neuromuscular function in painful knee osteoarthritis. Curr Pain Headache Rep. 2012 Dec;16(6):518-24. doi: 10.1007/s11916-012-0299-2.

  PMID: 23054978 BACKGROUND

• Gentilucci M, Toni I, Daprati E, Gangitano M. Tactile input of the hand and the control of reaching to grasp movements. Exp Brain Res. 1997 Mar;114(1):130-7. doi: 10.1007/pl00005612.

  PMID: 9125458 BACKGROUND

• Herzig D, Maffiuletti NA, Eser P. The Application of Neuromuscular Electrical Stimulation Training in Various Non-neurologic Patient Populations: A Narrative Review. PM R. 2015 Nov;7(11):1167-1178. doi: 10.1016/j.pmrj.2015.03.022. Epub 2015 Mar 31.

  PMID: 25839763 BACKGROUND

• Hopkins JT, Ingersoll CD, Edwards JE, Cordova ML. Changes in soleus motoneuron pool excitability after artificial knee joint effusion. Arch Phys Med Rehabil. 2000 Sep;81(9):1199-203. doi: 10.1053/apmr.2000.6298.

  PMID: 10987162 BACKGROUND

• Hortobagyi T, Garry J, Holbert D, Devita P. Aberrations in the control of quadriceps muscle force in patients with knee osteoarthritis. Arthritis Rheum. 2004 Aug 15;51(4):562-9. doi: 10.1002/art.20545.

  PMID: 15334428 BACKGROUND

• Hortobagyi T, Scott K, Lambert J, Hamilton G, Tracy J. Cross-education of muscle strength is greater with stimulated than voluntary contractions. Motor Control. 1999 Apr;3(2):205-19. doi: 10.1123/mcj.3.2.205.

  PMID: 10198150 BACKGROUND

• Kaelin-Lang A. Enhancing rehabilitation of motor deficits with peripheral nerve stimulation. NeuroRehabilitation. 2008;23(1):89-93.

  PMID: 18356592 BACKGROUND

• Kaelin-Lang A, Luft AR, Sawaki L, Burstein AH, Sohn YH, Cohen LG. Modulation of human corticomotor excitability by somatosensory input. J Physiol. 2002 Apr 15;540(Pt 2):623-33. doi: 10.1113/jphysiol.2001.012801.

  PMID: 11956348 BACKGROUND

• Konishi Y, Fukubayashi T, Takeshita D. Mechanism of quadriceps femoris muscle weakness in patients with anterior cruciate ligament reconstruction. Scand J Med Sci Sports. 2002 Dec;12(6):371-5. doi: 10.1034/j.1600-0838.2002.01293.x.

  PMID: 12453165 BACKGROUND

• Maffiuletti NA, Bizzini M, Schatt S, Munzinger U. A multi-joint lower-limb tracking-trajectory test for the assessment of motor coordination. Neurosci Lett. 2005 Aug 12-19;384(1-2):106-11. doi: 10.1016/j.neulet.2005.04.064.

  PMID: 15885904 BACKGROUND

• Palmieri-Smith RM, Thomas AC. A neuromuscular mechanism of posttraumatic osteoarthritis associated with ACL injury. Exerc Sport Sci Rev. 2009 Jul;37(3):147-53. doi: 10.1097/JES.0b013e3181aa6669.

  PMID: 19550206 BACKGROUND

• Poortvliet PC, Tucker KJ, Finnigan S, Scott D, Sowman P, Hodges PW. Cortical activity differs between position- and force-control knee extension tasks. Exp Brain Res. 2015 Dec;233(12):3447-57. doi: 10.1007/s00221-015-4404-8. Epub 2015 Aug 21.

  PMID: 26292962 BACKGROUND

• Radhakrishnan R, Sluka KA. Deep tissue afferents, but not cutaneous afferents, mediate transcutaneous electrical nerve stimulation-Induced antihyperalgesia. J Pain. 2005 Oct;6(10):673-80. doi: 10.1016/j.jpain.2005.06.001.

  PMID: 16202960 BACKGROUND

• Roos EM, Klassbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol. 1999;28(4):210-5. doi: 10.1080/03009749950155562.

  PMID: 10503556 BACKGROUND

• Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.

  PMID: 12801417 BACKGROUND

• Sharma L, Cahue S, Song J, Hayes K, Pai YC, Dunlop D. Physical functioning over three years in knee osteoarthritis: role of psychosocial, local mechanical, and neuromuscular factors. Arthritis Rheum. 2003 Dec;48(12):3359-70. doi: 10.1002/art.11420.

  PMID: 14673987 BACKGROUND

• Shirazi ZR, Shafaee R, Abbasi L. The effects of transcutaneous electrical nerve stimulation on joint position sense in patients with knee joint osteoarthritis. Physiother Theory Pract. 2014 Oct;30(7):495-9. doi: 10.3109/09593985.2014.903547. Epub 2014 Apr 3.

  PMID: 24697730 BACKGROUND

• Smith JW, Marcus RL, Peters CL, Pelt CE, Tracy BL, LaStayo PC. Muscle force steadiness in older adults before and after total knee arthroplasty. J Arthroplasty. 2014 Jun;29(6):1143-8. doi: 10.1016/j.arth.2013.11.023. Epub 2013 Dec 2.

  PMID: 24405624 BACKGROUND

• Tsauo JY, Cheng PF, Yang RS. The effects of sensorimotor training on knee proprioception and function for patients with knee osteoarthritis: a preliminary report. Clin Rehabil. 2008 May;22(5):448-57. doi: 10.1177/0269215507084597.

  PMID: 18441041 BACKGROUND

• Vance CG, Rakel BA, Blodgett NP, DeSantana JM, Amendola A, Zimmerman MB, Walsh DM, Sluka KA. Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial. Phys Ther. 2012 Jul;92(7):898-910. doi: 10.2522/ptj.20110183. Epub 2012 Mar 30.

  PMID: 22466027 BACKGROUND

• Veldman MP, Zijdewind I, Solnik S, Maffiuletti NA, Berghuis KM, Javet M, Negyesi J, Hortobagyi T. Direct and crossed effects of somatosensory electrical stimulation on motor learning and neuronal plasticity in humans. Eur J Appl Physiol. 2015 Dec;115(12):2505-19. doi: 10.1007/s00421-015-3248-z. Epub 2015 Sep 3.

  PMID: 26335625 BACKGROUND

• Veldman MP, Zijdewind I, Maffiuletti NA, Hortobagyi T. Motor Skill Acquisition and Retention after Somatosensory Electrical Stimulation in Healthy Humans. Front Hum Neurosci. 2016 Mar 16;10:115. doi: 10.3389/fnhum.2016.00115. eCollection 2016.

  PMID: 27014043 BACKGROUND

• Wu CW, Seo HJ, Cohen LG. Influence of electric somatosensory stimulation on paretic-hand function in chronic stroke. Arch Phys Med Rehabil. 2006 Mar;87(3):351-7. doi: 10.1016/j.apmr.2005.11.019.

  PMID: 16500168 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 3, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 3, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share