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Tenopathy; Lower LimbNCT04935398

Efficacy of Manual Therapy Combined With an Exercise Programme VS Combined Electrotherapy on Football Players With Adductor Tendinopathy

A study testing Physiotherapy in people with Tenopathy; Lower Limb, run by Universidad Católica de Ávila at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Groin pain associated with adductor tendinopathy is the second cause of muscle pathology in a football player (20%), so a good treatment taking into account both internal and external factors that may influence the pathology of our patient, would be the key to an improvement in the symptoms he may have. Read more about this study

Who is it for?
Ages 15 to 30 years, men only
Conditions the study is for
Tenopathy; Lower Limb
What is being tested?
Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
1 Mar 2021to 27 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 30 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age range between 15 and 30 years old.
  • Third division and third year national youth football players.
  • Males.
  • Average of 3 training sessions and 1 match per week.
  • Pain when performing the Copenhagen test or Squeeze test for 5 seconds (s).
  • Pain on palpation of the proximal insertion of the adductors.

Who cannot join

  • Players over 30 years of age and under 15 years of age.
  • Players with previous adductor surgery.
  • Players with inguinal hernia.
  • Players with signs or symptoms of urinary or genital pathology.
  • Players unable to attend study treatment sessions.
  • Players on medication during treatment.
  • Players who are undergoing other treatment for groin pathology or have had previous treatment of less than one month.
  • previous treatment of less than one month.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Católica de Ávila

    Ávila, 05005

Other trials in Spain

About this study

Official title: Efficacy of Manual Therapy Combined With an Exercise Programme Versus Combined Electrotherapy on Football Players With Adductor Tendinopathy: Randomised Clinical Trial

Background: Groin pain associated with adductor tendinopathy is the second cause of muscle pathology in a football player (20%), so a good treatment taking into account both internal and external factors that may influence the pathology of our patient, would be the key to an improvement in the symptoms he may have. Material and methods: Firstly, the pain threshold is measured by performing the Copenhagen compression test, and in a palpation at the proximal level of the adductors, the hip joint range (ROM) is measured and the HAGOS questionnaire is passed. Then, a sample of 20 participants (N = 20) is selected and randomly divided into two groups, a control group of 10 participants (n = 10), with a treatment based on electrotherapy combined with an exercise programme; and an experimental group of 10 participants (n = 10) with a treatment based on manual therapy combined with an exercise programme. Finally, they performed all measurements.

Being tested
Physiotherapy
Keywords
manual therapy,, electrotherapy,, groin pain and adductors.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhysiotherapyOther

    The aim is to test two treatment techniques against each other to see how effective they are.

Study groups in NCT04935398
Study groupRoleWhat they receive
Manual therapyExperimentalFootball players with adductor tendinopathy undergoing treatment consisting of manual therapy and therapeutic exercise.
Receives: Other: Physiotherapy
ElectrotherapyExperimentalFootballers with adductor tendinopathy undergoing electrotherapy treatment
Receives: Other: Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction assessed by the Visual Analogue Scale

    Visual analogue scale that measures the subjective pain of each individual. It is distributed from zero to ten, where zero is the minimum pain reported by the individual and ten is the maximum pain endured.

    Measured: 30 days

Secondary outcomes (2)

  1. Range of motion, articular

    Observe range of motion, articular

    Measured: 30 days

  2. Rate of functionality

    Measuring functionality after treatment in adductor tendinopathy

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start1 Mar 2021
  3. Primary completion1 May 2021
  4. Study completion27 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04935398
Sponsor's protocol ID
28/05/2021
Status last verified
Jun 2021
First submitted
28 May 2021
Last updated
23 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In the future, it is planned to share the research study with the rest of the scientific community through a paper submitted to a leading research journal.

Publications

  • Hopp SJ, Culemann U, Kelm J, Pohlemann T, Pizanis A. Osteitis pubis and adductor tendinopathy in athletes: a novel arthroscopic pubic symphysis curettage and adductor reattachment. Arch Orthop Trauma Surg. 2013 Jul;133(7):1003-9. doi: 10.1007/s00402-013-1777-7. Epub 2013 May 21.

    PubMed 23689650

  • Holmich P, Larsen K, Krogsgaard K, Gluud C. Exercise program for prevention of groin pain in football players: a cluster-randomized trial. Scand J Med Sci Sports. 2010 Dec;20(6):814-21. doi: 10.1111/j.1600-0838.2009.00998.x.

    PubMed 19883386

  • Jansen JA, Mens JM, Backx FJ, Kolfschoten N, Stam HJ. Treatment of longstanding groin pain in athletes: a systematic review. Scand J Med Sci Sports. 2008 Jun;18(3):263-74. doi: 10.1111/j.1600-0838.2008.00790.x. Epub 2008 Apr 6.

    PubMed 18397195

  • Paajanen H, Hermunen H, Karonen J. Pubic magnetic resonance imaging findings in surgically and conservatively treated athletes with osteitis pubis compared to asymptomatic athletes during heavy training. Am J Sports Med. 2008 Jan;36(1):117-21. doi: 10.1177/0363546507305454. Epub 2007 Aug 16.

    PubMed 17702996

  • Crane JD, Ogborn DI, Cupido C, Melov S, Hubbard A, Bourgeois JM, Tarnopolsky MA. Massage therapy attenuates inflammatory signaling after exercise-induced muscle damage. Sci Transl Med. 2012 Feb 1;4(119):119ra13. doi: 10.1126/scitranslmed.3002882.

    PubMed 22301554

  • Sefton JM, Yarar C, Carpenter DM, Berry JW. Physiological and clinical changes after therapeutic massage of the neck and shoulders. Man Ther. 2011 Oct;16(5):487-94. doi: 10.1016/j.math.2011.04.002. Epub 2011 May 12.

    PubMed 21570335

  • Machotka Z, Kumar S, Perraton LG. A systematic review of the literature on the effectiveness of exercise therapy for groin pain in athletes. Sports Med Arthrosc Rehabil Ther Technol. 2009 Mar 31;1(1):5. doi: 10.1186/1758-2555-1-5.

    PubMed 19331695

  • Pauli S, Willemsen P, Declerck K, Chappel R, Vanderveken M. Osteomyelitis pubis versus osteitis pubis: a case presentation and review of the literature. Br J Sports Med. 2002 Feb;36(1):71-3. doi: 10.1136/bjsm.36.1.71.

    PubMed 11867499

  • Weir A, Jansen JA, van de Port IG, Van de Sande HB, Tol JL, Backx FJ. Manual or exercise therapy for long-standing adductor-related groin pain: a randomised controlled clinical trial. Man Ther. 2011 Apr;16(2):148-54. doi: 10.1016/j.math.2010.09.001. Epub 2010 Oct 16.

    PubMed 20952244

  • Moreno-Perez V, Travassos B, Calado A, Gonzalo-Skok O, Del Coso J, Mendez-Villanueva A. Adductor squeeze test and groin injuries in elite football players: A prospective study. Phys Ther Sport. 2019 May;37:54-59. doi: 10.1016/j.ptsp.2019.03.001. Epub 2019 Mar 2.

    PubMed 30856592

  • Serner A, van Eijck CH, Beumer BR, Holmich P, Weir A, de Vos RJ. Study quality on groin injury management remains low: a systematic review on treatment of groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):813. doi: 10.1136/bjsports-2014-094256. Epub 2015 Jan 29.

    PubMed 25633830

  • Short S, Short G, Strack D, Anloague P, Brewster B. A COMBINED TREATMENT APPROACH EMPHASIZING IMPAIRMENT-BASED MANUAL THERAPY AND EXERCISE FOR HIP-RELATED COMPENSATORY INJURY IN ELITE ATHLETES: A CASE SERIES. Int J Sports Phys Ther. 2017 Nov;12(6):994-1010.

    PubMed 29158960

  • Schoberl M, Prantl L, Loose O, Zellner J, Angele P, Zeman F, Spreitzer M, Nerlich M, Krutsch W. Non-surgical treatment of pubic overload and groin pain in amateur football players: a prospective double-blinded randomised controlled study. Knee Surg Sports Traumatol Arthrosc. 2017 Jun;25(6):1958-1966. doi: 10.1007/s00167-017-4423-z. Epub 2017 Jan 16.

    PubMed 28093636

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy in people with Tenopathy; Lower Limb, run by Universidad Católica de Ávila at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction assessed by the Visual Analogue Scale (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04935398, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.

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