NCT05970003

Brief Summary

Groin pain that relates to the adductor muscle usually represents in the groin region specifically in superior internal thigh. Tears or strains may happen within the muscles itself, tears or strains mainly occurs at musculotendinous junctions or within the tendons. Adductor strain is a familiar but mostly ignored cause of groin injury and pain among athletes. Risk factors include past hip or groin injury, age, weak adductors, muscle fatigue, lessen range of motion, and deficient stretching of the adductor muscle complex.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

June 27, 2023

Last Update Submit

April 29, 2024

Conditions

Keywords

Holmich protocolCopenhagen exercisesgroin painadductor strain

Outcome Measures

Primary Outcomes (3)

  • Numerical pain rating scale (NPRS)

    Numeric Pain Rating Scale for Pain In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.

    upto 4th weeks

  • Lower Extremity Functional Scale (LEFS)

    Lower Extremity Functional Scale (LEFS) The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The final version of the LEFS consists 20 items, each with a maximum score of 4. The total possible score of 80 indicates a high functional level (Appendix). The scale is one page, can be filled out by most patients in less than 2 minutes, and is scored by tallying the responses for all of the items. Scoring is performed without the use of a calculator or computer and requires approximately 20 seconds

    upto 4th weeks

  • Manual Muscle Testing

    MMT grades are usually labelled with the following terms: "zero," "trace," "poor," "fair," "good," and "normal." In addition, manual muscle testing grades can be further described using a numerical scale from 0 through 5.

    upto 4th weeks

Study Arms (2)

Group A: Copenhagen exercise

ACTIVE COMPARATOR

Group A will receive the Copenhagen exercise, also known as the adductor strengthening protocol, is a dynamic and high-intensity exercise. It doesn't require any special equipment and can be done in any training center. There are 3 different levels of exercise were performed by players. 1. Level 1: Side-lying hip adduction exercise. 2. Level 2: Copenhagen adduction exercises while both arms support at the knee. 3. Level 3: Copenhagen adduction exercise - primary support at the ankle and minor support at the knee.

Other: Copenhagen exercises

Group B : Holmich Exercises

ACTIVE COMPARATOR

Group B will receive Holmich continues to provide the strongest evidence for the efficacy of exercise as an ARGP treatment. The Holmich treatment protocol exercise includes static and dynamic and/or isometric and isotonic strengthening exercises for hip adductors and abductors and also for abdominal muscles. There are 6 Different types of exercises were performed by players who were a participant with 3 sets of 10 repetitions with 15 sec recovery period.

Other: Holmich exercises

Interventions

Group A performs copenhagen exercises Both groups will perform their routine warm ups and cool downs the total duration of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10 repetitions with 15 sec recovery period. Hip extensor and flexor stretching and strengthening.

Group A: Copenhagen exercise

The Holmich treatment protocol exercise includes static and dynamic and/or isometric and isotonic strengthening exercises for hip adductors and abductors and also for abdominal muscles. There are 6 Different types of exercises were performed by players who were a participant with 3 sets of 10 repetitions with 15 sec recovery period. Both groups will perform their routine warm ups and cool downs the total duration of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10 repetitions with 15 sec recovery period. Hip extensor and flexor stretching and strengthening.

Group B : Holmich Exercises

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male soccer player age group 18-30 years
  • Groin pain during or after game
  • Persistent groin pain over 2-3 weeks
  • Pain at palpation of groin
  • Positive pain with Adductor squeeze test

You may not qualify if:

  • Low back pain
  • Infection (UTI)
  • Malignancy
  • Recent fractures or injuries
  • Hip osteoarthritis
  • Inguinal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Sports Board

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • Mercurio M, Corona K, Galasso O, Cerciello S, Morris BJ, Guerra G, Gasparini G. Soccer players show the highest seasonal groin pain prevalence and the longest time loss from sport among 500 athletes from major team sports. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):2149-2157. doi: 10.1007/s00167-022-06924-5. Epub 2022 Mar 8.

    PMID: 35258646BACKGROUND
  • Haroy J, Clarsen B, Wiger EG, Oyen MG, Serner A, Thorborg K, Holmich P, Andersen TE, Bahr R. The Adductor Strengthening Programme prevents groin problems among male football players: a cluster-randomised controlled trial. Br J Sports Med. 2019 Feb;53(3):150-157. doi: 10.1136/bjsports-2017-098937. Epub 2018 Jun 10.

    PMID: 29891614BACKGROUND
  • Schaber M, Guiser Z, Brauer L, Jackson R, Banyasz J, Miletti R, Hassen-Miller A. The Neuromuscular Effects of the Copenhagen Adductor Exercise: A Systematic Review. Int J Sports Phys Ther. 2021 Oct 1;16(5):1210-1221. doi: 10.26603/001c.27975. eCollection 2021.

    PMID: 34631242BACKGROUND
  • Almeida MO, Silva BN, Andriolo RB, Atallah AN, Peccin MS. Conservative interventions for treating exercise-related musculotendinous, ligamentous and osseous groin pain. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD009565. doi: 10.1002/14651858.CD009565.pub2.

    PMID: 23740671BACKGROUND

Study Officials

  • Samrood Akram, Mphil

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

August 1, 2023

Study Start

October 5, 2023

Primary Completion

March 8, 2024

Study Completion

March 10, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations