Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis

NCT05955430 | Unknown

• 1 other identifier: KOA1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Physiotherapy; Physical Therapy; Conditioned Pain Modulation; Temporal Summation of pain; Knee pain; PENS; Percutaneous electrical stimulation; Pain education

Outcome Measures

Primary Outcomes (7)

• Change from baseline to one month in WOMAC

  The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.

  At baseline and at one month

• Change from baseline to three months in WOMAC

  The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.

  At baseline and at three months

• Change from baseline to six months in WOMAC

  The Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.

  At baseline and at six months

• Change from baseline to immediately after the first session in VAS

  The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.

  At baseline and immediately after the first session

• Change from baseline to one month in VAS

  The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.

  At baseline and at one month

• Change from baseline to three months in VAS

  The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.

  At baseline and at three months

• Change from baseline to six months in VAS

  The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.

  At baseline and at six months

Secondary Outcomes (45)

• Change from baseline to immediately after the first session in PPT

  At baseline and immediately after the first session

• Change from baseline to one month in PPT

  At baseline and at one month

• Change from baseline to three months in PPT

  At baseline and at three months

• Change from baseline to six months in PPT

  At baseline and at six months

• Change from baseline to immediately after the first session in CPM

  At baseline and immediately after the first session

Study Arms (3)

Exercise, education and PENS

EXPERIMENTAL

Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of percutaneous electrical stimulation (PENS).

Other: Therapeutic exercise; Other: Pain education; Other: Percutaneous electrical stimulation

Exercise, education and TENS

ACTIVE COMPARATOR

Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of transcutaneous electrical stimulation (TENS).

Other: Therapeutic exercise; Other: Pain education; Other: Transcutaneous electrical stimulation

Exercise, education and placebo stimulation

PLACEBO COMPARATOR

Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of placebo stimulation.

Other: Therapeutic exercise; Other: Pain education; Other: Placebo stimulation

Interventions

Therapeutic exercise OTHER

It consists of strengthening exercises and gradual walking. The lower limb strengthening exercises are individualized and progressive for each patient for twelve weeks. There will be eight face-to-face sessions over four weeks. And then the patient will continue with those exercises for eight more weeks. In addition, they must perform twelve weeks of progressive walking until they are walking at least 30 minutes, 5 days a week at a moderate intensity (defined as moderate shortness of breath while walking).

Exercise, education and PENS; Exercise, education and TENS; Exercise, education and placebo stimulation

Pain education OTHER

A therapeutic pain education program for patients will be implemented. There will be four 30-minute face-to-face sessions (one session per week). The objective is to change the participants' conceptualization of pain. From seeing pain as a marker of tissue damage to a marker of the body's perceived need for protection. Contents include basic structure of the nervous system, distinction between nociception and pain, peripheral and central sensitization, neuroplasticity and benefits of exercise.

Exercise, education and PENS; Exercise, education and TENS; Exercise, education and placebo stimulation

Percutaneous electrical stimulation OTHER

A TENS (100 Hz 100 ms) current will be applied through four needles located in the knee for 30 minutes. Eight sessions will be held during a month (two per week). The distribution of the channels will be for the first channel anode in lateral anterior zone and cathode in medial anterior zone and for the second channel anode in Hoffa's fat and cathode in goose foot. Participants will be able to adjust the amplitude to a strong and manageable sensory stimulation intensity that was not strong enough to cause muscle contraction.

Exercise, education and PENS

Transcutaneous electrical stimulation OTHER

A TENS (100 Hz 100 ms) current will be applied through four patches located in the knee for 30 minutes. Eight sessions will be held during a month (two per week). The distribution of the channels will be for the first channel anode in lateral anterior zone and cathode in medial anterior zone and for the second channel anode in Hoffa's fat and cathode in goose foot. Participants will be able to adjust the amplitude to a strong and manageable sensory stimulation intensity that was not strong enough to cause muscle contraction.

Exercise, education and TENS

Placebo stimulation OTHER

To perform the dry needling placebo, modified needles will be used according to the validation performed by Mitchell et al. 2018, since they generate more puncture sensation than normal needles, which has been shown to generate more analgesia and to be more effective as a placebo. To perform placebo TENS, the protocol established by Rakel et al. 2010 will be used, which consists of applying a TENS of 100 Hz and 100 ms for 30 seconds and then lowering the intensity during the following 15 seconds. Eight sessions will be held during a month (two per week).

Exercise, education and placebo stimulation

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years
• Have activity related joint pain
• Have morning stiffness ≤30 min
• Knee pain of at least 6 months duration
• OA diagnosis by physician
• Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (\< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire)

You may not qualify if:

• Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease).
• Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)
• Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke).
• Inflammatory arthritis (including rheumatoid arthritis)
• Fibromyalgia
• Previously operated knee is the most painful knee
• Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia)
• Severe depression
• Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire)
• Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist)
• Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)

Sponsors & Collaborators

• Josue Fernandez Carnero: lead

Study Sites (1)

Universidad Rey Juan Carlos

Madrid, 28047, Spain

RECRUITING

Related Publications (10)

• Stanton TR, Braithwaite FA, Butler D, Moseley GL, Hill C, Milte R, Ratcliffe J, Maher C, Tomkins-Lane C, Pulling BW, MacIntyre E, Esterman A, Stanford T, Lee H, Fraysse F, Metcalf B, Mouatt B, Bennell K. The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis. BMC Musculoskelet Disord. 2021 Aug 28;22(1):738. doi: 10.1186/s12891-021-04561-6.

  PMID: 34454458 BACKGROUND

• Rakel B, Cooper N, Adams HJ, Messer BR, Frey Law LA, Dannen DR, Miller CA, Polehna AC, Ruggle RC, Vance CG, Walsh DM, Sluka KA. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain. 2010 Mar;11(3):230-8. doi: 10.1016/j.jpain.2009.07.007. Epub 2009 Nov 27.

  PMID: 19945354 BACKGROUND

• Mitchell UH, Stoneman P, Larson RE, Page GL. The Construction of Sham Dry Needles and Their Validity. Evid Based Complement Alternat Med. 2018 Jun 14;2018:9567061. doi: 10.1155/2018/9567061. eCollection 2018.

  PMID: 30013605 BACKGROUND

• Fingleton C, Smart K, Moloney N, Fullen BM, Doody C. Pain sensitization in people with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Jul;23(7):1043-56. doi: 10.1016/j.joca.2015.02.163. Epub 2015 Mar 5.

  PMID: 25749012 BACKGROUND

• Shim JW, Jung JY, Kim SS. Effects of Electroacupuncture for Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2016;2016:3485875. doi: 10.1155/2016/3485875. Epub 2016 Oct 13.

  PMID: 27818699 BACKGROUND

• Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.

  PMID: 29864043 BACKGROUND

• Pisters MF, Veenhof C, van Meeteren NL, Ostelo RW, de Bakker DH, Schellevis FG, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007 Oct 15;57(7):1245-53. doi: 10.1002/art.23009.

  PMID: 17907210 BACKGROUND

• Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.

  PMID: 26051220 BACKGROUND

• Kroon FP, van der Burg LR, Buchbinder R, Osborne RH, Johnston RV, Pitt V. Self-management education programmes for osteoarthritis. Cochrane Database Syst Rev. 2014 Jan 15;2014(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.

  PMID: 24425500 BACKGROUND

• Stanton TR, Karran EL, Butler DS, Hull MJ, Schwetlik SN, Braithwaite FA, Jones HG, Moseley GL, Hill CL, Tomkins-Lane C, Maher C, Bennell K. A pain science education and walking program to increase physical activity in people with symptomatic knee osteoarthritis: a feasibility study. Pain Rep. 2020 Sep 24;5(5):e830. doi: 10.1097/PR9.0000000000000830. eCollection 2020 Sep-Oct.

  PMID: 33490835 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Josué Fernández Carnero, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo Rodríguez Lagos, MSc

CONTACT

914888949; l.rodriguezla.2019@alumnos.urjc.es

Josué Fernández Carnero, PhD

CONTACT

914888949; josue.fernandez@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 21, 2023
• Study Start: July 6, 2023
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)