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Groin InjuryNCT05589623

The Effectiveness of the Copenhagen Adduction Exercise on Soccer Players With Groin Pain or Injury

A study testing Copenhagen adduction exercise and Usual rehabilitation program in people with Groin Injury, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

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

Groin injuries are among the three most common and time-consuming injuries in soccer, accounting for 19% of all injuries, with 0.1-2.1 injuries per 1000 hours of play. The Copenhagen Adduction Exercise (CAE) has been showing promising results in improving Eccentric Hip Adduction Strength (EHADS), leading to reducing… Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Groin Injury
What is being tested?
Copenhagen adduction exercise and Usual rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSaudi Arabia
Study dates
15 Jan 2023to 27 Apr 2023
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 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Soccer players aged between 18 to 40 years.
  • They have groin pain or injury within two months during sports.
  • Pain or tenderness on palpation of adductors in clinical examination.
  • Pain on resisted hip adduction movement in clinical examination.
  • Desire to continue the sport at the same level.

Who cannot join

  • Groin pain or injury not involving the adductors on clinical examination.
  • They have any clinical finding indications of femoral or inguinal hernia.
  • Evidence of prostatitis, chronic urinary tract disease.
  • Evidence of hip joint osteoarthritis or hip joint disease.
  • Bursitis of the hip or groin region.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Imam Abdulrahman Bin Faisal University

    Dammam

Other trials in Saudi Arabia

About this study

Official title: Adding the Copenhagen Adductor Exercise to Standard Groin Injury Rehabilitation: A Randomized Controlled Trial

Groin injuries are among the three most common and time-consuming injuries in soccer, accounting for 19% of all injuries, with 0.1-2.1 injuries per 1000 hours of play. The Copenhagen Adduction Exercise (CAE) has been showing promising results in improving Eccentric Hip Adduction Strength (EHADS), leading to reducing the risk of groin pain and injury. This clinical trial aims to evaluate the effects of CAE on adductors strength, hip joint range of motion (ROM), and Patient-reported outcome measures among athletes with groin pain or injury.

The main question it aims to answer is:

Read more

Does the CAE improve EHAD strength, hip joint ROM, and patient-reported outcome measures among soccer players with groin pain or injury?

Researchers will assess the participants' pre and post-intervention to determine the effects of CAE on adductors strength, hip joint ROM, and Patient-reported outcome measures.

Read the detailed description

Study design: A Double-Blinded Randomized Controlled Trial.

Researchers will allocate a specific number for each participant for randomization. Then, an online website will be applied to randomize these numbers into two groups, intervention and control groups. An independent person not involved in the study will allocate the participants using concealed opaque envelopes.

Study setting:

This study will be held at different physical therapy and rehabilitation clinic, ministry of health, Saudi Arabia

Recruitment and study population:

Participants will be recruited from physical therapy outpatient clinics in the South region.

Participants will be recruited and randomized into two groups, intervention (CAE) and control. Participants assigned to the intervention group will receive the CAE in addition to the regular physical therapy rehabilitation program for eight weeks. Due to the heaviness and the high dynamic demands of CAE, a modified progressive Copenhagen adduction (MPCA) program has been created. The MPCA was adapted from the original CAE to lessen the risk of delayed onset muscle soreness (DOMS) and facilitate high participant compliance.

Participants assigned to the control group will receive the same physical therapy rehabilitation program as the intervention group except for the CAE.

Time plan of the study:

Recruitment is expected to commence in January 2023 and conclude in April 2023. After completing the recruitment process, data will be collected for eight weeks. After the last inclusion, the intervention will continue for eight weeks.

Assessment:

An experienced physiotherapist, blinded to the study, will perform all assessments to guarantee that the tests are consistent and that the process is standardized. Assessments will be at baseline and post-intervention. The duration between the baseline assessment and the start of the intervention should not exceed two weeks. After the assessment, every participant will receive the proper group intervention according to his/her randomization. Participants will be told not to reveal their group assignments to the assessor during the study period.

Demographic variables and descriptive:

The investigators will document the following variables: age, sex, height, BMI, Sports level, duration of symptoms, and location of symptoms as recommended by the minimum reporting criteria for clinical research on groin pain in athletes.

Sample size estimation:

The sample size calculation for this study was performed using G*Power software (v. 3.1, Heinrich-Heine-Universität, Düsseldorf, Germany), with an alpha level of 0.05 and a power (1-β) of 80%. Based on a previous study examining the effects of exercise therapy on adductor-related groin pain in athletes, it required 15 participants per group to detect an expected between-group difference of 0.15 Nm/kg and a standard deviation (SD) of 0.54 Nm/kg.

Statistical analysis:

All analyses will be performed using the Statistical Package for the Social Sciences version 27. The study's findings will be presented following the Consolidated Standards of Reporting Trials (CONSORT). Shapiro-Wilk test will be used to test for normality. The statistical analysis test will be carried out based on the collected data. Demographic data will be presented as mean and standard deviation. The suggested statistical analysis measure will be the repeated measures analysis of variance (ANOVA), calculated for each dependent variable. Each repeated measure ANOVA will have one within factor (test: pre and post) and one between factor (group: training and control). Results will be significant at P value <0.05 and a Confidence Interval (CI) of 95%. A statistician will be consulted for further correction after data collection.

Conditions
Groin Injury
Being tested
Copenhagen adduction exercise, Usual rehabilitation program
Keywords
Copenhagen Adduction Exercise, Eccentric Hip Adduction Strength, Groin injury, groin pain, Soccer. athletes

What participants receive

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

  • Copenhagen adduction exerciseOther

    The CAE is a progressive eccentric training program that enhances hip adduction. The fact that exercises are done with a partner and do not require special equipment makes them more useful in a team setting. The MPCA program, adapted from the original CAE, included six progressive levels for eight weeks, beginning with an assisted isometric adduction hold (level 1) and progressing incrementally to a complete CAE as the original exercise (level 6). The progression in levels will depend on a pain score ≤ 4/10 numeric rating scale (NRS) in the adductor squeeze test and post-session DOMS score ≤ 4/10 NRS.

  • Usual rehabilitation programOther

    The usual rehabilitation program will include leg swings extension/flexion, leg swings abduction/adduction, standing hip circles, isometric standing hip adduction using elastic bands, stretching exercises, balance training on a wobble board, and single leg coordination exercises. Difficulty and volume are progressing incrementally.

Study groups in NCT05589623
Study groupRoleWhat they receive
Copenhagen adduction exerciseExperimentalThe CAE is a body-weight exercise that mainly works the groin and hip adductors. It has a significant eccentric component, meaning the muscles work while lengthening. The CAE is a simple isolated eccentric exercise that does not require special equipment. Due to the heaviness and the high dynamic demands of CAE, a modified progressive Copenhagen adduction (MPCA) program has been created. The MPCA exercise was adapted from the original CAE to lessen the risk of delayed onset muscle soreness (DOMS) and facilitate high participant compliance. An experienced physical therapist will include the MPCA in the usual rehabilitation program for eight weeks, twice weekly. Sessions will last between 30 and 120 minutes.
Receives: Other: Copenhagen adduction exercise
Usual rehabilitation programActive comparatorThe rehabilitation program will be an active exercise based on the available literature and considers the clinical experience in managing groin injuries. An experienced physical therapist will supervise the rehabilitation program for two sessions weekly for eight weeks, with difficulty and volume progressing incrementally. Sessions will last between 30 and 120 minutes.
Receives: Other: Usual rehabilitation program

What is being measured

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

  1. Change in eccentric hip adduction strength from baseline

    A portable hand-held dynamometer (microFET2) will be used for the test. A blind physiotherapist will perform pre and post-testing. Each patient's affected leg will be tested. The examiner will position the hand-held dynamometer 5 cm proximal to the most prominent part of the medial malleolus. Eccentric hip adduction strength will be measured in a break test with the patient in a side-lying position, with the leg being tested in a straight position. The participant will perform a 3-5 second isometric maximum voluntary contraction against the dynamometer before the physiotherapist performs a contraction break to determine the eccentric hip adduction strength. The patient will complete one practice trial before three maximal tests are performed, with the best result recorded. The standardized command by the examiner will be "go ahead-push-push-push-push-push." Leg length will be used to calculate torque and be adjusted to body mass (Nm/kg).

    Measured: At the end of the intervention sessions (8 weeks)

  2. Change in hip joint range of motion measures from baseline

    Hip joint ROM can be reliably assessed using a goniometer. The assessor will perform an internal and external hip joint range of motion testing with the subject supine and the hip and knee in 90 degrees of flexion pre-and post-testing will be performed. An assistant will be used to ensure that the hip and knee remain in their proper positions. The affected leg will be rotated to the maximum range of passive internal rotation (IR), external rotation (ER), and abduction movement (ABD). The standard goniometer will be used to make the measurements, and the testing period will be approximately ten minutes.

    Measured: At the end of the intervention sessions (8 weeks)

Secondary outcomes (1)
  1. Change in the Copenhagen Hip and Groin Outcome Score

    The Copenhagen Hip and Groin Outcome Score (HAGOS) was created as a patient-reported outcome questionnaire, primarily targeting young-aged to middle-aged, physically active individuals with long-standing hip and groin pain. HAGOS, was existed for specifically assessing those reporting groin pain. The HAGOS comprises six subscales that assess pain, symptoms, physical function in daily life, physical function in sport and recreation, participation in physical activities, and hip and/or groin-related quality of life (QOL). Scores for each subscale range from 0 (extreme hip/groin problems) to 100 (no hip/groin problems). The Arabic version of HAGOS has been recommended for assessing symptoms, activity limitations, participation restrictions, and quality of life in physically active, young, middle-aged patients with hip and/or groin pain.

    Measured: At the end of the intervention sessions (8 weeks)

Timeline

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

  1. First posted21 Oct 2022
  2. Study start15 Jan 2023
  3. Primary completion3 Apr 2023
  4. Study completion27 Apr 2023

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05589623
Sponsor's protocol ID
IRB-PGS-2023-03-011
Status last verified
Jul 2023
First submitted
14 Oct 2022
Last updated
6 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Delahunt E, Thorborg K, Khan KM, Robinson P, Holmich P, Weir A. Minimum reporting standards for clinical research on groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):775-81. doi: 10.1136/bjsports-2015-094839.

    PubMed 26031644
  • Haroy J, Thorborg K, Serner A, Bjorkheim A, Rolstad LE, Holmich P, Bahr R, Andersen TE. Including the Copenhagen Adduction Exercise in the FIFA 11+ Provides Missing Eccentric Hip Adduction Strength Effect in Male Soccer Players: A Randomized Controlled Trial. Am J Sports Med. 2017 Nov;45(13):3052-3059. doi: 10.1177/0363546517720194. Epub 2017 Aug 14.

    PubMed 28806100
  • Ishoi L, Sorensen CN, Kaae NM, Jorgensen LB, Holmich P, Serner A. Large eccentric strength increase using the Copenhagen Adduction exercise in football: A randomized controlled trial. Scand J Med Sci Sports. 2016 Nov;26(11):1334-1342. doi: 10.1111/sms.12585. Epub 2015 Nov 21.

    PubMed 26589483
  • 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
  • Mosler AB, Crossley KM, Thorborg K, Whiteley RJ, Weir A, Serner A, Holmich P. Hip strength and range of motion: Normal values from a professional football league. J Sci Med Sport. 2017 Apr;20(4):339-343. doi: 10.1016/j.jsams.2016.05.010. Epub 2016 Aug 23.

    PubMed 28185809
  • Serner A, Jakobsen MD, Andersen LL, Holmich P, Sundstrup E, Thorborg K. EMG evaluation of hip adduction exercises for soccer players: implications for exercise selection in prevention and treatment of groin injuries. Br J Sports Med. 2014 Jul;48(14):1108-14. doi: 10.1136/bjsports-2012-091746. Epub 2013 Mar 19.

    PubMed 23511698
  • Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.

    PubMed 21478502
  • Thorborg K, Tijssen M, Habets B, Bartels EM, Roos EM, Kemp J, Crossley KM, Holmich P. Patient-Reported Outcome (PRO) questionnaires for young to middle-aged adults with hip and groin disability: a systematic review of the clinimetric evidence. Br J Sports Med. 2015 Jun;49(12):812. doi: 10.1136/bjsports-2014-094224. Epub 2015 Jan 13.

    PubMed 25586913
  • Nussbaumer S, Leunig M, Glatthorn JF, Stauffacher S, Gerber H, Maffiuletti NA. Validity and test-retest reliability of manual goniometers for measuring passive hip range of motion in femoroacetabular impingement patients. BMC Musculoskelet Disord. 2010 Aug 31;11:194. doi: 10.1186/1471-2474-11-194.

    PubMed 20807405
  • Holmich P, Uhrskou P, Ulnits L, Kanstrup IL, Nielsen MB, Bjerg AM, Krogsgaard K. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet. 1999 Feb 6;353(9151):439-43. doi: 10.1016/S0140-6736(98)03340-6.

    PubMed 9989713
  • Alsirhani AA, Muaidi QI, Nuhmani S, Thorborg K, Husain MA, Al Attar WSA. The effectiveness of the Copenhagen adduction exercise on improving eccentric hip adduction strength among soccer players with groin injury: a randomized controlled trial. Phys Sportsmed. 2024 Oct;52(5):497-506. doi: 10.1080/00913847.2024.2321958. Epub 2024 Mar 1.

    PubMed 38376593

Questions about this trial

What is this clinical trial studying?

A study testing Copenhagen adduction exercise and Usual rehabilitation program in people with Groin Injury, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

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 5 inclusion and 5 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 6 Jul 2023. 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 Saudi Arabia. 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?

Change in eccentric hip adduction strength from baseline (time frame: At the end of the intervention sessions (8 weeks)). The study lists 2 primary outcomes in all. 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 NCT05589623, which also lists 11 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 6 Jul 2023.

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