Groin StrainNCT05970003
Comparative Effects of Copenhagen and Holmich Exercises in Hip Adductor
A study testing Copenhagen exercises and Holmich exercises in people with Groin Strain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Groin Strain
- What is being tested?
- Copenhagen exercises and Holmich exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Oct 2023to 10 Mar 2024
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- • Low back pain
- Infection (UTI)
- Malignancy
- Recent fractures or injuries
- Hip osteoarthritis
- Inguinal hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Copenhagen and Holmich Exercises in Hip Adductor Related Groin Pain, Strength and Lower Extremity Function in Soccer Players
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.
Read the detailed description
This study will be a randomized clinical trial and will be conducted in Pakistan sports board and coaching center. Non-probability consecutive sampling will be used to collect the data. Sample size of this research is 46 subjects with age group between 18-30 years will be taken. Data will be collected from the patients of adductor strain that causes groin pain by using tools Numeric Pain Rating Scale for pain, Adductor Muscle Strength Test by Hand Held Dynamometer, The Copenhagen Hip and Groin Outcome Score (HAGO's) questionnaire and Lower Extremity Functional Scale (LEFS). An informed consent will be taken. Squeeze test will be performed to evaluate the adductor related groin pain. The subjects will be divided into two groups i.e. Group A and Group B. 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. Group B will receive Holmich continues to provide the strongest evidence for the efficacy of exercise as an ARGP treatment. 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 Keywords groin pain, Holmich protocol, Copenhagen exercise, adductor strain.
- Conditions
- Groin Strain
- Being tested
- Copenhagen exercises, Holmich exercises
- Keywords
- Holmich protocol, Copenhagen exercises, groin pain, adductor strain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copenhagen exercisesOther
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.
Holmich exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Holmich exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: upto 4th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start5 Oct 2023
- Primary completion8 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Groin StrainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Mphil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970003
- Sponsor's protocol ID
- REC/RCR & AHS/23/0412
- Status last verified
- Apr 2024
- First submitted
- 27 Jun 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35258646Haroy 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.
PubMed 29891614Schaber 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.
PubMed 34631242Almeida 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.
PubMed 23740671
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Copenhagen and Holmich Exercises in Hip Adductor Related Groin Pain, Strength and Lower Extremity Function in Soccer Players
- ClinicalTrials.gov ID
- NCT05970003
- Acronym / sponsor ID
- REC/RCR & AHS/23/0412
- Conditions
- Groin Strain
- Keywords
- Holmich protocol, Copenhagen exercises, groin pain, adductor strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a randomized clinical trial and will be conducted in Pakistan sports board and coaching center. Non-probability consecutive sampling will be used to collect the data. Sample size of this research is 46 subjects with age group between 18-30 years will be taken. Data will be collected from the patients of adductor strain that causes groin pain by using tools Numeric Pain Rating Scale for pain, Adductor Muscle Strength Test by Hand Held Dynamometer, The Copenhagen Hip and Groin Outcome Score (HAGO's) questionnaire and Lower Extremity Functional Scale (LEFS). An informed consent will be taken. Squeeze test will be performed to evaluate the adductor related groin pain. The subjects will be divided into two groups i.e. Group A and Group B. 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. Group B will receive Holmich continues to provide the strongest evidence for the efficacy of exercise as an ARGP treatment. 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 Keywords groin pain, Holmich protocol, Copenhagen exercise, adductor strain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Copenhagen exercise | Active comparator | Other: Copenhagen exercisesGroup 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. |
| Group B : Holmich Exercises | Active comparator | Other: Holmich exercisesGroup 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Male soccer player age group 18-30 years
Key exclusion criteria (6 listed)
- • Low back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copenhagen exercisesGroup 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. | Other | Group A: Copenhagen exercise |
| Holmich exercisesThe 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. | Other | Group B : Holmich Exercises |
Primary outcome
Numerical pain rating scale (NPRS)
Time frame: upto 4th weeks
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.
Lower Extremity Functional Scale (LEFS)
Time frame: upto 4th weeks
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
Manual Muscle Testing
Time frame: upto 4th weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 35258646Mercurio 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.
- Background: PubMed 29891614Haroy 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.
- Background: PubMed 34631242Schaber 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.
- Background: PubMed 23740671Almeida 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samrood Akram, Mphil principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copenhagen exercises and Holmich exercises in people with Groin Strain, run by Riphah International University at 1 site in Pakistan.
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 6 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 30 Apr 2024. 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 Pakistan. 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?
Numerical pain rating scale (NPRS) (time frame: upto 4th weeks). The study lists 3 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 NCT05970003, which also lists 4 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 30 Apr 2024.