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Sports Physical TherapyNCT04642300

Holmich Protocol and Myofascial Release Technique Effect on Groin Pain in Tennis Players

A study testing Holmich Protocol and Myofascial Release Technique in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.

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

The aim of this study is to determine the effect of Homlich Protocol and Myofacial release technique on groin pain in tennis players. A total of 14 players will be included in the clinical trail. Read more about this study

Who is it for?
Ages 18 to 35 years, men only
Conditions the study is for
Sports Physical Therapy
What is being tested?
Holmich Protocol and Myofascial Release Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 sitePakistan
Study dates
4 Mar 2020to 20 Dec 2020
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 35 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male Gender
  • Age: 18 - 35 years
  • Groin pain for at least 2 months
  • 3 - 7 pain score on NPRS
  • Playing Sports for atleast 1 year

Who cannot join

  • Femoral or inguinal hernia
  • Chronic urinary tract disorder or prostatitis
  • Disease, fracture of the pelvis or the lower limbs inhibiting the participant from the completing the treatment plan
  • Entrapment of the genitofemoral or back pain felt between T10 and L5 levels and consisting of the facet joints
  • Virulent Ilioinguinal nerve
  • Inability to follow the active physical training plan
  • Use of non-steroidal anti-inflammatory drugs during the study
  • Participation in principled strength training of the hip adductors for more than once a week in the 6 months prior to the study.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

Official title: Effect of Holmich Protocol and Myofascial Release Technique on Groin Pain in Tennis Players

The aim of this study is to determine the effect of Homlich Protocol and Myofacial release technique on groin pain in tennis players. A total of 14 players will be included in the clinical trail. There will be one group of 7 players in which Holmich protocol will be applied while in the other group of 7 players will be given Myofascial Release Technique which includes Transverse friction massage and Stretching. Data will be collected by outcome measures before and after the exercise protocol is given. Treatment will be administered three times a week (on even or odd days). The duration of Holmich Protocol each session is about 90 min for module 1 (first two weeks) and 120 min for module 2 (from the third week). From the third week, the athletes will be asked to perform exercises from module 1 every other day, between the treatment sessions. While passive treatment will be given for 30 mins per session. During the treatment course and before the final evaluation, no athletic activity will be permitted . Injuries data will be collected prospectively by respective coaches. Coaches will be trained for identification and classification of injuries.

Read the detailed description

Groin pain arising from sports injuries is widespread, especially among those who participate in sports that involve repetitive rotational movements such as kicking and turning as in soccer. This type of injury is the fourth most common sports injury, with soccer players suffering from long-term symptoms and frequent relapses. The injury rate is 1.015-1.133 per 1000 hours of play, which is equivalent to 11%-16% of all sports injuries. The prognosis for exercise- related groin pain is not clear. Injured athletes may be forced to wait a long time before returning to sports activity free of restriction.

It is known that adductor-related groin injuries are the most common cause of groin injury, accounting for 69% of groin injuries in football and 58% across all forms of sport. As limited range of hip abduction and hip internal rotation and decreased hip adductor strength (absolute and comparative to the hip abductors) are considered potential risk factors for groin injury. Adductor-related groin pain is often treated without surgery. Among different conservative approaches, it appears that exercise therapy (ET) is more effective than other conservative treatment methods such as electrotherapy, manual therapy or steroid injections. Unfortunately, however, many important factors including frequency, duration and the exact amount of resistance or perceived exertion to be used in the ET protocols have not been carefully recorded in clinical trials. To our best knowledge, the randomised clinical trial carried out by Holmich et al in 1999 still offers the best evidence for the effectiveness of exercise as a prescription for the treatment of adductor-related groin pain. Holmich et al collated the results of ET (based on isometric and isotonic strengthening of the hip abductor/adductor and the abdominal muscles) with results from physiotherapy. They evaluated successful treatment (based on pain measures), patients' subjective global assessments and their return to sport without groin pain at the same level as before the injury. 'Successful treatment' as described in their study is an unfeasible and non-validated measure for evaluating outcome; on the other hand, the published results by Holmich et al was not compared with any such other treatment.

Yousefzadeh A et al conducted a study which checked the effect of Holmich Protocol on groin pain and its results showed to be an effective treatment.

Weir A et al performed multi modal treatment(MMT) in comparison to exercise therapy(ET), results showed MMT to be more effective then ET.

Sernar A et al did a systemic review on treatment of groin players which showed low quality studies present for groin injury management.

Holmich P et al performed a randomized trial on effects of active physical training(AT) on groin pain, results showed AT to be very effective on groin pain.

Kalichman L and Ben David C did a narrative review on the effect of self-myofascial release(SMFR) and concluded that there was a significant increase in joint range of motion and no decrease in muscle force.

Timothy C.Mauntel et al performed myofascial release technique to increase physical performance measurements to check its effectiveness. The systematic review observed a significant change in range of motion but no significant change in muscle function.

Melih Paksoy and Umit Sekmen performed a review of current diagnosis and treatment modilities which showed that response rates to conservative treatment for inguinal pain is very low.

Dines et al performed a study on tennis injuries and showed that groin pain to be present around 3% to 21%.

In the current study, we will reproduce Holmich et al research along with Myofascial release technique to treat long-standing adductor-related groin pain (LSAGP) and analyse the short-term flow of alterations in pain and functional ability. Furthermore, as limited range of hip abduction and hip internal rotation and decreased hip adductor strength (absolute and comparative to the hip abductors) are considered potential risk factors for groin injury, we will also measure these variables as our outcomes. The purpose of this study is to obtain an objective evaluation of the effect of Holmich protocol and Myofascial release technique to compare which is better in treating LSAGP.

Being tested
Holmich Protocol, Myofascial Release Technique
Keywords
Groin pain, Holimch protocol, Myofascial release technique

What participants receive

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

  • Holmich ProtocolProcedure or surgery

    Module 1 (1st two weeks):

    i)Isometric adduction ii)Abdominal sit-ups iii)Isometric adduction iv)Compound abdominal sit-ups and hip flexion v)Balance exercise on wobble board vi)One-foot exercise on sliding board

    Module 2 (from 3rd week):

    i)Leg abduction and adduction exercise carried out in side lying ii)Low back extension exercise prone on the end of bench iii)One leg weight pulling abduction/adduction standing iv)Abdominal sit ups v)One leg coordination exercise vi)Training in sideways motion vii)Balance exercise on wobble board

  • Myofascial Release TechniqueProcedure or surgery

    1. Transverse friction massage: 10 mins on painful area of adductor-tendon insertion into pubic bone
    2. Stretching of adductor muscles, hamstrings muscles and hip flexors:3 times and each stretch is 30s with Contract relax technique
Study groups in NCT04642300
Study groupRoleWhat they receive
Holmich ProtocolActive comparatorTreatment will be administered three times a week (on even or odd days). The duration of each session was about 90 min for module 1 (first two weeks) and 120 min for module 2 (from the third week). From the third week, the athletes were asked to perform exercises from module 1 every other day, between the treatment sessions
Receives: Procedure: Holmich Protocol
Myofascial Release TechniqueActive comparatorTreatment wiil be given twice a week as individual treatment by the physiotherapist. The duration of treatment is about 30 min.
Receives: Procedure: Myofascial Release Technique

What is being measured

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

  1. Hip Range of motion

    The hip range of motion including abduction, adduction, external and internal rotation in 90°of flexion will be measured by an adjustable goniometer.

    Measured: 8 Weeks

  2. T-Agility TEST

    Set out four cones 5 yards = 4.57 m, 10 yards = 9.14 m. The subject starts at cone A. On the command of the timer, the subject sprints to cone B and touches the base of the cone with their right hand. They then turn left and shuffle sideways to cone C, and also touches its base, this time with their left hand. Then shuffling sideways to the right to cone D and touching the base with the right hand. They then shuffle back to cone B touching with the left hand, and run backwards to cone A. The stopwatch is stopped as they pass cone A

    Measured: 8 Weeks

  3. Edgren Side Test (ESST)

    Five cones or lines are placed in a line, three feet apart (12 feet total between the two outside cones). The starting position is at the centre cone, facing forward with feet straddling the center line. At the command 'go', the participant sidesteps to the right until their right foot touches or crosses the outside cone or tape mark. The participant then sidesteps to the left until their left foot touches or crosses the left outside cone or tape mark. The participant sidesteps back and forth to the outside cones as rapidly as possible for 10 seconds.

    Measured: 8 Weeks

  4. Triple Hop Test (THT)

    In the triple hop test, the aim is to jump as far as possible on a single leg three consecutive times, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.

    Measured: 8 Weeks

  5. Visual Analogue Scale Pain Score (VAS)

    The visual analog scale (VAS) scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions.

    Measured: 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 posted24 Nov 2020
  2. Study start4 Mar 2020
  3. Primary completion30 Nov 2020
  4. Study completion20 Dec 2020

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
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04642300
Sponsor's protocol ID
REC/00722 Rohail Babar
Status last verified
Mar 2021
First submitted
29 May 2020
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Caudill P, Nyland J, Smith C, Yerasimides J, Lach J. Sports hernias: a systematic literature review. Br J Sports Med. 2008 Dec;42(12):954-64. doi: 10.1136/bjsm.2008.047373. Epub 2008 Jul 4.

    PubMed 18603584
  • Hawkins RD, Hulse MA, Wilkinson C, Hodson A, Gibson M. The association football medical research programme: an audit of injuries in professional football. Br J Sports Med. 2001 Feb;35(1):43-7. doi: 10.1136/bjsm.35.1.43.

    PubMed 11157461
  • Walden M, Hagglund M, Werner J, Ekstrand J. The epidemiology of anterior cruciate ligament injury in football (soccer): a review of the literature from a gender-related perspective. Knee Surg Sports Traumatol Arthrosc. 2011 Jan;19(1):3-10. doi: 10.1007/s00167-010-1172-7. Epub 2010 Jun 9.

    PubMed 20532868
  • Holmich P, Thorborg K, Dehlendorff C, Krogsgaard K, Gluud C. Incidence and clinical presentation of groin injuries in sub-elite male soccer. Br J Sports Med. 2014 Aug;48(16):1245-50. doi: 10.1136/bjsports-2013-092627. Epub 2013 Aug 16.

    PubMed 23956334
  • 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
  • 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.

    PubMed 23740671
  • 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
  • Holmich P. Long-standing groin pain in sportspeople falls into three primary patterns, a "clinical entity" approach: a prospective study of 207 patients. Br J Sports Med. 2007 Apr;41(4):247-52; discussion 252. doi: 10.1136/bjsm.2006.033373. Epub 2007 Jan 29.

    PubMed 17261557
  • Tyler TF, Nicholas SJ, Campbell RJ, McHugh MP. The association of hip strength and flexibility with the incidence of adductor muscle strains in professional ice hockey players. Am J Sports Med. 2001 Mar-Apr;29(2):124-8. doi: 10.1177/03635465010290020301.

    PubMed 11292035
  • Whittaker JL, Small C, Maffey L, Emery CA. Risk factors for groin injury in sport: an updated systematic review. Br J Sports Med. 2015 Jun;49(12):803-9. doi: 10.1136/bjsports-2014-094287. Epub 2015 Apr 1.

    PubMed 25833903
  • 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
  • Yousefzadeh A, Shadmehr A, Olyaei GR, Naseri N, Khazaeipour Z. Effect of Holmich protocol exercise therapy on long-standing adductor-related groin pain in athletes: an objective evaluation. BMJ Open Sport Exerc Med. 2018 Jun 26;4(1):e000343. doi: 10.1136/bmjsem-2018-000343. eCollection 2018.

    PubMed 30018787
  • 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
  • Kalichman L, Ben David C. Effect of self-myofascial release on myofascial pain, muscle flexibility, and strength: A narrative review. J Bodyw Mov Ther. 2017 Apr;21(2):446-451. doi: 10.1016/j.jbmt.2016.11.006. Epub 2016 Nov 14.

    PubMed 28532889
  • Dines JS, Bedi A, Williams PN, Dodson CC, Ellenbecker TS, Altchek DW, Windler G, Dines DM. Tennis injuries: epidemiology, pathophysiology, and treatment. J Am Acad Orthop Surg. 2015 Mar;23(3):181-9. doi: 10.5435/JAAOS-D-13-00148. Epub 2015 Feb 9.

    PubMed 25667400

Questions about this trial

What is this clinical trial studying?

A study testing Holmich Protocol and Myofascial Release Technique in people with Sports Physical Therapy, 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 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 24 Mar 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 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?

Hip Range of motion (time frame: 8 Weeks). The study lists 5 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 NCT04642300, which also lists 17 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 24 Mar 2021.

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