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Evaluation of integrated therapeutic measures on functional and psychological outcomes in athletes with iliotibial band syndrome; An interventional study

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SLCTR Registration Number

SLCTR/2021/032


Date of Registration

11 Nov 2021

The date of last modification

Nov 11, 2021



Application Summary


Scientific Title of Trial

Evaluation of integrated therapeutic measures on functional and psychological outcomes in athletes with iliotibial band syndrome; An interventional study


Public Title of Trial

Evaluating the efficacy of, integrated therapeutic measures on functional and psychological outcomes in athletes with iliotibial band syndrome; a Randomized Controlled study


Disease or Health Condition(s) Studied

iliotibial band syndrome


Scientific Acronym

none


Public Acronym

None


Brief title

Evaluation of integrated therapeutic measures on functional and psychological outcomes in athletes with iliotibial band syndrome; An interventional study


Universal Trial Number

U1111-1269-0282


Any other number(s) assigned to the trial and issuing authority

None


Trial Details


What is the research question being addressed?

Would integrated therapeutic measures such as, a combination of myo-facial release (MT) Kinesio taping (KT) and Thera band strengthening (TBS) improve functional outcome, muscle strength, pain and Lower Extremity Functional Scale/ General Health Questionnaire 12 (LEFS/GHQ12) scores accredited to Iiliotibial band syndrome among athletes referred to the sports & exercise medicine clinic of Teaching hospital Karapitiya?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Investigators, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

Study setting: Sports & Exercise Medicine Clinic of Teaching Hospital Karapitiya.

Intervention:

A one week wash out period for each experimental group must be recommended to minimise the bias prior to commence any intervention. If the history suggests that the participants who are already suited without a wash out period will be incorporated to interventions from day one.

If the participants experience severe pain during washout period , they will be prescribed standard method of treatment with celecoxib 100 mg bd and omeprazole 20 mg bd and same method of treatment will be prescribed if someone experiences severe pain during the period of intervention.

On day one (Day 01), prior to the intervention therapy, each participant will be given three assessment questionnaires, the LEFS, the GHQ12 and demographic data questionnaire to record their Functional capacity(FC) perception, mental health and demographic data. Then five study groups will be allocated their respective treatment methods according to the following method

Group a: Athletes with ITBS will receive pre-designed Manual Therapy (MT) programme followed by pre-designed Kinesio Therapy (KT) session for injured side Illio Tibial Band (ITB) every week for four consecutive sessions.

Group b: Athletes with ITBS will receive pre-designed Manual Therapy (MT) program followed by pre-designed Thera Band Strengthening (TBS) session for injured side Illio Tibial Band (ITB) every week for four consecutive sessions.

Group c: Athletes with ITBS will receive pre-designed Kinesio Therapy (KT) session followed by pre-designed Thera Band Strengthening (TBS) session for injured side ITB every week for four consecutive sessions.

Group d: Athletes with ITBS will receive a pre-designed Manual Therapy (MT) program and pre-designed Kinesio Therapy (KT) session followed by Thera Band Strengthening (TBS) session for injured side Illio Tibial Band (ITB) every week for four consecutive sessions.

Group e: (Control Group) Athletes with ITBS on conventional physiotherapy modalities of ‘electro therapy’(Includes Infra-Red Heat (IRH) for 15 min and Ultrasound (US) for 30 min or Short Wave for 15 mins) other than Manual Therapy (MT), Kinesio Therapy (KT) and Thera Band Strengthening (TBS) therapies..

All interventions will be carried out by the principal investigator

Randomisation- A computer generated random numbering system will be used to categorise the participants and it will be categorised using total sample population of 350 participants in to five equal groups (Gr a, Gr b, Gr c, Gr d and Gr e,) enrolling 70 participants into each group.


Inclusion criteria

• Athletes who are diagnosed to have ITBS and who requires rehabilitation. (diagnosis criteria for ITBS: The ailment is predominantly diagnosed on clinical grounds. Specific symptoms, signs and functional testing can detect the disorder with a significant accuracy. The characteristics of ITBS include number of clinical symptoms & signs found on patients having lateral knee pain. The classical sign of diagnosing ITBS is the point tenderness just proximal to Lateral femoral condyle (LFC).

Clinical history a. Grade I Generalized lateral knee ache after training, which resolves with rest. b. Grade II Specific lateral knee pain at end of training activity that usually resolves with rest and does not affect performance. c. Grade II Lateral knee pain at onset of activity that interferes with performance. d. Grade IV Lateral knee pain limits training and is felt during activities of daily living.

Physical examination – special tests a. Positive Noble Compression Test (cardinal sign) b. Positive Thomas Test c. Positive Ober test d. Positive Lateral step-down test

Case definition of ITBS diagnosis Clinical history and four special tests must be positive for the confirmation of diagnosis

• Age >18 years and < 50 years • Injury no more than three months old. • Both male and female athletes


Exclusion criteria

• Participants who are suspected to be having following conditions around knee, Any old femur fracture, tibial fracture and chondromalacia patella, bilateral ITBFS,Malignancy, Rheumatic arthritis, bleeding disorders, Acute skin infections • Patients who have had any form of Mayo - Fascial Release (MFR) and or KT therapies within past two weeks. • Known skin allergies to adhesive plaster or KT • Participants who are having any contraindication for MT - Total Contraindications (TC):Fever, Contagious diseases, Pain medication, pacemakers, Neuritis, Skin diseases/CellulitisRecent operations/ Haematoma, Acute injuries/FracturesHypersensitivity to touch,Under the influence of drugs or alcohol

Local Contraindications:
Varicose veins, Undiagnosed lumps or bumps, Pregnancy, Bruising Cuts, Abrasions, and Wounds, Sunburn, Undiagnosed pain, Inflammation, including arthritis
Medical Contraindications (MC):Thrombosis, PhlebitisHypertensionAngina, those with Psoriasis or EczemaOsteoporosisEpilepsy, Diabetes, Bell’s palsyOedemaGynecological infection

• Participants who are having any significant conditions including medical, surgical neurological and psychological/psychiatric disorders. • Participants who understand only Tamil language



Primary outcome(s)

1.

Improvement of functional outcome measured using, 1. Handheld Dynamometer (HHD) and Hip abductor strength 2. Single-Limb Mini Squat (SLMS): Assessment Procedures 3.Y Balance Test Psychological status using, 4.GHQ 12 questionnaire 5. Pain status using, visual analogue scale for pain (100 mm VAS)

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  1. Day 1 14, and 28
  2. Day 1 and 28
  3. Day 1 and 28
  4. Day 1 and 28
  5. Day 1,7,14,21 and 28
]

Secondary outcome(s)

1.

None

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Target number/sample size

350 (70 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2021-11-11


Anticipated end date

2026-03-17


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Part of the estimated budget will be obtained from the Department of Education, Training & Research (ET&R) of the Ministry of Health under the provision of research allowance granted to the medical officers in the department of health and apart from the r


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-03-17


Approval number

2021.P.001( 12/01/2021)


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Ruhuna.
Institutional Address:P.O. Box 70 Faculty of Medicine, University of Ruhuna Galle Sri ankaL
Telephone:+94912232288
Email: ethics@med.ruh.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Sampath Gunawardane
Professor, Department of Physiology, Faculty of Medicine, University of Ruhuna
Faculty of Medicine, University of Ruhuna
0714160258


sampathgu@yahoo.com

Contact Person for Public Queries

Sanka Thebuwanaarachchi
Olympic sports physician
Sports medicine unit Teaching Hospital Karapitiya Galle Sri Lanka
0773141177


sankatheekshana@yahoo.com


Primary study sponsor/organization

Teaching Hospital Karapitiya

Teaching Hospital Karapitiya, Galle. Sri Lanka.



Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results