The Effectiveness of the Copenhagen Adduction Exercise on Soccer Players With Groin Pain or Injury
Condition: Groin Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

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 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:

      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.
    

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.
    

Intervention name(s): Copenhagen adduction exercise; Usual rehabilitation program
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Copenhagen Adduction Exercise; Eccentric Hip Adduction Strength; Groin injury, groin pain; Soccer. athletes