NCT02947451

Brief Summary

Patients with knee Osteoarthritis have high prevalence of pain , requiring ever more precise interventions in their management. This study aims to investigate the immediate effects of manual therapy and TENS on pain in patients with knee Osteoarthritis. Knowledge of best interventions favors reducing spending on health and safety for the patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

September 6, 2016

Last Update Submit

July 6, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity in Visual Analogic Scale

    It consists of 11 points, ranging from 0 ( no pain) to 10 ( maximum possible pain ), the volunteer instructed to quantify their knee pain present at the time of evaluation.

    Immediately

  • Pressure Pain Threshold in Algometer

    They will be scored 7 points, the first being located at the apex of the patella, the second three cm medial to the apex of the patella, the third two centimeters higher than the second, the fourth two centimeters lower than the second, the fifth three centimeters lateral to the apex of the patella, the sixth two centimeters above the fifth and seventh two centimeters below the fifth. Participants will be instructed to report to the appraiser whenever the feeling in the stimulus site becomes clearly painful. There will be two measurements at each point, each starting from point 1 to 7. It shall be considered the average of each isolated point and the average of the averages of the points how test result.

    Immediately

Secondary Outcomes (3)

  • Global Rating of Change Scale

    Immediately and 72 hours after intervention

  • Pain intensity in Visual Analogic Scale 72 hours after intervention

    72 hours after intervention

  • Pressure Pain Threshold in Algometer 72 hours after intervention

    72 hours after intervention

Study Arms (2)

Manual therapy

EXPERIMENTAL

In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee, in a single application.

Other: Manual Therapy

TENS

EXPERIMENTAL

In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application.

Other: TENS

Interventions

In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee. Stretching, myofascial release and mobilizations will be held for 30 seconds, with three repetitions of each. The intervention will be applied only once.

Manual therapy
TENSOTHER

In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application. The intensity will be defined by the patient, should the stimulus be considered intense, but pleasant to it.

Also known as: Transcutaneous electrical nerve stimulation
TENS

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis diagnosed by clinical criteria established by the American College of Rheumatology and radiological criteria of Kelgren-Lawrence
  • Age over 50 years
  • Pain intensity above 2 on the VAS

You may not qualify if:

  • Other systemic inflammatory disease
  • Changes in sensitivity
  • Use of anti-inflammatory steroids, tranquillizers and/or antidepressants in the last month
  • Analgesic in last 24 hours
  • Use of cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Ceara

Fortaleza, Ceará, 60430-160, Brazil

Location

Related Publications (25)

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    PMID: 15640302BACKGROUND
  • Deyle GD, Gill NW, Allison SC, Hando BR, Rochino DA. Knee OA: which patients are unlikely to benefit from manual PT and exercise? J Fam Pract. 2012 Jan;61(1):E1-8.

    PMID: 22220299BACKGROUND
  • Alshami AM. Knee osteoarthritis related pain: a narrative review of diagnosis and treatment. Int J Health Sci (Qassim). 2014 Jan;8(1):85-104. doi: 10.12816/0006075.

    PMID: 24899883BACKGROUND
  • French HP, Brennan A, White B, Cusack T. Manual therapy for osteoarthritis of the hip or knee - a systematic review. Man Ther. 2011 Apr;16(2):109-17. doi: 10.1016/j.math.2010.10.011. Epub 2010 Dec 13.

    PMID: 21146444BACKGROUND
  • Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.

    PMID: 16305269BACKGROUND
  • Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.

    PMID: 3741515BACKGROUND
  • KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.

    PMID: 13498604BACKGROUND
  • Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis JC, Campbell AJ; MOA Trial team. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis Cartilage. 2013 Apr;21(4):525-34. doi: 10.1016/j.joca.2012.12.014. Epub 2013 Jan 8.

    PMID: 23313532BACKGROUND
  • Brantingham JW, Bonnefin D, Perle SM, Cassa TK, Globe G, Pribicevic M, Hicks M, Korporaal C. Manipulative therapy for lower extremity conditions: update of a literature review. J Manipulative Physiol Ther. 2012 Feb;35(2):127-66. doi: 10.1016/j.jmpt.2012.01.001.

    PMID: 22325966BACKGROUND
  • Jansen MJ, Viechtbauer W, Lenssen AF, Hendriks EJ, de Bie RA. Strength training alone, exercise therapy alone, and exercise therapy with passive manual mobilisation each reduce pain and disability in people with knee osteoarthritis: a systematic review. J Physiother. 2011;57(1):11-20. doi: 10.1016/S1836-9553(11)70002-9.

    PMID: 21402325BACKGROUND
  • Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.

    PMID: 16777467BACKGROUND
  • Pollard H, Ward G, Hoskins W, Hardy K. The effect of a manual therapy knee protocol on osteoarthritic knee pain: a randomised controlled trial. J Can Chiropr Assoc. 2008 Dec;52(4):229-42.

    PMID: 19066697BACKGROUND
  • Basedow M, Williams H, Shanahan EM, Runciman WB, Esterman A. Australian GP management of osteoarthritis following the release of the RACGP guideline for the non-surgical management of hip and knee osteoarthritis. BMC Res Notes. 2015 Oct 5;8:536. doi: 10.1186/s13104-015-1531-z.

    PMID: 26438323BACKGROUND
  • McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.

    PMID: 24462672BACKGROUND
  • Bjordal JM, Johnson MI, Lopes-Martins RA, Bogen B, Chow R, Ljunggren AE. Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials. BMC Musculoskelet Disord. 2007 Jun 22;8:51. doi: 10.1186/1471-2474-8-51.

    PMID: 17587446BACKGROUND
  • Nnoaham KE, Kumbang J. WITHDRAWN: Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2014 Jul 10;(7):CD003222. doi: 10.1002/14651858.CD003222.pub3. No abstract available.

    PMID: 25010718BACKGROUND
  • 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: 22466027BACKGROUND
  • Mascarin NC, Vancini RL, Andrade ML, Magalhaes Ede P, de Lira CA, Coimbra IB. Effects of kinesiotherapy, ultrasound and electrotherapy in management of bilateral knee osteoarthritis: prospective clinical trial. BMC Musculoskelet Disord. 2012 Sep 22;13:182. doi: 10.1186/1471-2474-13-182.

    PMID: 22999098BACKGROUND
  • Bellamy N. Osteoarthritis clinical trials: candidate variables and clinimetric properties. J Rheumatol. 1997 Apr;24(4):768-78.

    PMID: 9101516BACKGROUND
  • Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

    PMID: 20046623BACKGROUND
  • Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)--validation of a Swedish version. Scand J Med Sci Sports. 1998 Dec;8(6):439-48. doi: 10.1111/j.1600-0838.1998.tb00465.x.

    PMID: 9863983BACKGROUND
  • Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

    PMID: 9699158BACKGROUND
  • Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.

    PMID: 20418016BACKGROUND
  • Cheing GL, Tsui AY, Lo SK, Hui-Chan CW. Optimal stimulation duration of tens in the management of osteoarthritic knee pain. J Rehabil Med. 2003 Mar;35(2):62-8. doi: 10.1080/16501970306116.

    PMID: 12691335BACKGROUND
  • Law PP, Cheing GL. Optimal stimulation frequency of transcutaneous electrical nerve stimulation on people with knee osteoarthritis. J Rehabil Med. 2004 Sep;36(5):220-5. doi: 10.1080/16501970410029834.

    PMID: 15626162BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Musculoskeletal ManipulationsTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationElectric Stimulation TherapyAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

September 6, 2016

First Posted

October 27, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2018

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations