NCT04642300

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 4, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

May 29, 2020

Last Update Submit

March 22, 2021

Conditions

Keywords

Groin painHolimch protocolMyofascial release technique

Outcome Measures

Primary Outcomes (5)

  • 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.

    8 Weeks

  • 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

    8 Weeks

  • 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.

    8 Weeks

  • 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.

    8 Weeks

  • 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.

    8 Weeks

Study Arms (2)

Holmich Protocol

ACTIVE COMPARATOR

Treatment 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

Procedure: Holmich Protocol

Myofascial Release Technique

ACTIVE COMPARATOR

Treatment wiil be given twice a week as individual treatment by the physiotherapist. The duration of treatment is about 30 min.

Procedure: Myofascial Release Technique

Interventions

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

Holmich Protocol

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

Myofascial Release Technique

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (17)

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    PMID: 18603584BACKGROUND
  • 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.

    PMID: 11157461BACKGROUND
  • 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.

    PMID: 20532868BACKGROUND
  • 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.

    PMID: 23956334BACKGROUND
  • 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.

    PMID: 20952244BACKGROUND
  • 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
  • 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.

    PMID: 9989713BACKGROUND
  • 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.

    PMID: 17261557BACKGROUND
  • 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.

    PMID: 11292035BACKGROUND
  • 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.

    PMID: 25833903BACKGROUND
  • 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.

    PMID: 19331695BACKGROUND
  • 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.

    PMID: 30018787BACKGROUND
  • 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.

    PMID: 25633830BACKGROUND
  • 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.

    PMID: 28532889BACKGROUND
  • 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.

    PMID: 25667400BACKGROUND
  • Mauntel TC, Clark MA, Padua DA. Effectiveness of Myofascial Release Therapies on Physical Performance Measurements: A Systematic Review . Athl Train Sport Heal Care. 2014 Jul 1;6(4):189-96.

    BACKGROUND
  • Barnes MF. Efficacy study of the effect of a myofascial release treatment technique on obtaining pelvic symmetry. J Bodyw Mov Ther. 1997 Oct;1(5):289-96.

    BACKGROUND

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Muhammad Faheem Afzal, *PhD

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 29, 2020

First Posted

November 24, 2020

Study Start

March 4, 2020

Primary Completion

November 30, 2020

Study Completion

December 20, 2020

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations