Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy.

NCT ID: NCT05793918

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2023-09-15

Brief Summary

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The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of awareness about the options of the physiotherapist treatment. It is necessary to do studies about effectiveness of therapeutic percutaneous electrolysis and neuromodulation. This technique enables treatment of the tendinopathies. To analyze the effectiveness of therapeutic percutaneou electrolysis and neuromodulation in the treatment of supraspinatus muscle tendinopathy. Single center randomized controlled trial, parallel treatment design. A specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants will be randomly assigned to receive treatmen for 4 weeks: percutaneou electrolysis and neuromodulation associated with eccentric exercises or conventional treatment of Physiotherapy with the same eccentric exercises. Both interventions were performed under ultrasound guidance with a portable ultrasound (General Electric LogicE). Data will be collected by a blinded evaluator.

Detailed Description

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Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions. Participants were asked to perform the exercise program on an individual basis twice every day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal abduction (concentric phase) and a slow return to the initial position (eccentric phase) included first the concentric phase, and the eccentric phase was slowly conducted. The exercise program was taught by a physiotherapist in the first session and monitored in the subsequent sessions.

Conditions

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Supraspinatus Tendinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A specialist physician will be diagnosed the supraspinatus tendinopathy.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Single (Outcomes Assessor)

Study Groups

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Percutaneous Electrolysis and neuromodulation.

The intervention for this group consisted of Therapeutic Percutaneous Electrolysis and neuromodulation. Patient received once week for four weeks associated with eccentric exercises device at home.

Group Type EXPERIMENTAL

Therapeutic Percutaneous Electrolysis an neuromodulation

Intervention Type OTHER

Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.

Control group

The multimodal physical therapy program includes 10 sessions of:

Ultrasound pulsatil therapy (US) for 10 minutes , transcutaneous electric nerve stimulation (TENS) for 20 minutes ans associated with eccentric exercises device at home.

Group Type ACTIVE_COMPARATOR

Conventional group

Intervention Type OTHER

Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.

Interventions

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Therapeutic Percutaneous Electrolysis an neuromodulation

Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.

Intervention Type OTHER

Conventional group

Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with supraspinatus tendinopathies that do not improve with conventional physiotherapy or pharmacological therapy protocols.
* Subjects who are in an active state of pain, who present painful symptoms in a sensitive and painful area of the tendon of insertion of the supraspinatus muscle in the humerus.

Exclusion Criteria

* Individuals who have received surgery intervention in the same shoulder, or have suffered fractures or dislocations in the same shoulder.
* Individuals have received the proposed treatment in one month´s period previously.
* Individuals who suffering from cervical radiculopathies, fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
* Pregnant women can not receive this treatment intervention.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Manuel Rodriguez Huguet

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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manuel rodriguez huguet, Physiotherapy

Role: STUDY_DIRECTOR

University of Cádiz

Locations

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Policlínica Santa María

Cadiz, Cádiz, Spain

Site Status

Countries

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Spain

References

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Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009 Jun;43(6):409-16. doi: 10.1136/bjsm.2008.051193. Epub 2008 Sep 23.

Reference Type BACKGROUND
PMID: 18812414 (View on PubMed)

McCreesh K, Lewis J. Continuum model of tendon pathology - where are we now? Int J Exp Pathol. 2013 Aug;94(4):242-7. doi: 10.1111/iep.12029.

Reference Type BACKGROUND
PMID: 23837792 (View on PubMed)

Khan KM, Cook JL, Maffulli N, Kannus P. Where is the pain coming from in tendinopathy? It may be biochemical, not only structural, in origin. Br J Sports Med. 2000 Apr;34(2):81-3. doi: 10.1136/bjsm.34.2.81. No abstract available.

Reference Type BACKGROUND
PMID: 10786860 (View on PubMed)

Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.

Reference Type BACKGROUND
PMID: 25122629 (View on PubMed)

Arias-Buria JL, Truyols-Dominguez S, Valero-Alcaide R, Salom-Moreno J, Atin-Arratibel MA, Fernandez-de-Las-Penas C. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2015;2015:315219. doi: 10.1155/2015/315219. Epub 2015 Nov 15.

Reference Type BACKGROUND
PMID: 26649058 (View on PubMed)

Rodriguez-Huguet M, Gongora-Rodriguez J, Rodriguez-Huguet P, Ibanez-Vera AJ, Rodriguez-Almagro D, Martin-Valero R, Diaz-Fernandez A, Lomas-Vega R. Effectiveness of Percutaneous Electrolysis in Supraspinatus Tendinopathy: A Single-Blinded Randomized Controlled Trial. J Clin Med. 2020 Jun 12;9(6):1837. doi: 10.3390/jcm9061837.

Reference Type BACKGROUND
PMID: 32545583 (View on PubMed)

Lewis JS. Rotator cuff tendinopathy. Br J Sports Med. 2009 Apr;43(4):236-41. doi: 10.1136/bjsm.2008.052175. Epub 2008 Sep 18.

Reference Type BACKGROUND
PMID: 18801774 (View on PubMed)

Osborne JD, Gowda AL, Wiater B, Wiater JM. Rotator cuff rehabilitation: current theories and practice. Phys Sportsmed. 2016;44(1):85-92. doi: 10.1080/00913847.2016.1108883. Epub 2015 Nov 7.

Reference Type BACKGROUND
PMID: 26548634 (View on PubMed)

Garcia Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30.

Reference Type BACKGROUND
PMID: 28135129 (View on PubMed)

Rodriguez-Huguet M, Gongora-Rodriguez J, Lomas-Vega R, Martin-Valero R, Diaz-Fernandez A, Obrero-Gaitan E, Ibanez-Vera AJ, Rodriguez-Almagro D. Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial. J Clin Med. 2020 Jul 1;9(7):2068. doi: 10.3390/jcm9072068.

Reference Type BACKGROUND
PMID: 32630241 (View on PubMed)

Littlewood C, Ashton J, Chance-Larsen K, May S, Sturrock B. Exercise for rotator cuff tendinopathy: a systematic review. Physiotherapy. 2012 Jun;98(2):101-9. doi: 10.1016/j.physio.2011.08.002. Epub 2011 Oct 5.

Reference Type BACKGROUND
PMID: 22507359 (View on PubMed)

Dejaco B, Habets B, van Loon C, van Grinsven S, van Cingel R. Eccentric versus conventional exercise therapy in patients with rotator cuff tendinopathy: a randomized, single blinded, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):2051-2059. doi: 10.1007/s00167-016-4223-x. Epub 2016 Jun 28.

Reference Type BACKGROUND
PMID: 27351548 (View on PubMed)

Heron SR, Woby SR, Thompson DP. Comparison of three types of exercise in the treatment of rotator cuff tendinopathy/shoulder impingement syndrome: A randomized controlled trial. Physiotherapy. 2017 Jun;103(2):167-173. doi: 10.1016/j.physio.2016.09.001. Epub 2016 Sep 21.

Reference Type BACKGROUND
PMID: 27884499 (View on PubMed)

Kinsella R, Cowan SM, Watson L, Pizzari T. A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2017 Nov 14;3:45. doi: 10.1186/s40814-017-0190-3. eCollection 2017.

Reference Type BACKGROUND
PMID: 29163981 (View on PubMed)

Lin ML, Chiu HW, Shih ZM, Lee PY, Li PZ, Guo CH, Luo YJ, Lin SC, Lin KY, Hsu YM, Pang A, Pang W. Two Transcutaneous Stimulation Techniques in Shoulder Pain: Transcutaneous Pulsed Radiofrequency (TPRF) versus Transcutaneous Electrical Nerve Stimulation (TENS): A Comparative Pilot Study. Pain Res Manag. 2019 Feb 4;2019:2823401. doi: 10.1155/2019/2823401. eCollection 2019.

Reference Type BACKGROUND
PMID: 30863472 (View on PubMed)

Other Identifiers

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Percutaneous Electrolysis

Identifier Type: -

Identifier Source: org_study_id

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