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Iliotibial Band SyndromeNCT07118371

Clamshell and Frog Pump Exercises on Pain, Range of Motion, and Functional Disability

A study testing Clamshell exercise and Frog pump exercises in people with Iliotibial Band Syndrome, run by University of Lahore 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 study will be randomized clinical trial. This study will be conducted at the University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 92 will be randomly allocated into two experimental groups, (46 participants in each group), by the lottery method. Read more about this study

Who is it for?
Ages 20 to 40 years
Conditions the study is for
Iliotibial Band Syndrome
What is being tested?
Clamshell exercise and Frog pump exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 sitePakistan
Study dates
9 Sep 2024to 15 Sep 2025
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 20 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both Males and Females
  • Patients between the ages of 20 and 40
  • Work shift (at least 4 hours a day) 5 times a week
  • Positive Ober test
  • Patients who have ITB band syndrome in one or both legs

Who cannot join

  • Pregnant women
  • Individuals have diseases or disorders that affect mobility.
  • Recent Fractures of the lower limb
  • Soft tissue injury of lower limb like ankle sprain etc.
  • Severe systemic illnesses like COPD, Angina, or MI.
  • Recent history of trauma
  • Any psychiatric illness like panic disorders, obsessive-compulsive disorder, etc.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • University of Lahore Teaching Hospital

    Lahore, Punjab Province, 55150

Other trials in Pakistan

About this study

Official title: Effects of Clamshell and Frog Pump Exercises on Pain, Range of Motion, and Functional Disability in Long-standing Sales Workers With Iliotibial Band Syndrome

The study will be randomized clinical trial. This study will be conducted at the University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 92 will be randomly allocated into two experimental groups, (46 participants in each group), by the lottery method. All the screened and willing participants were randomly allocated into two groups (Group A: Experimental group / Clamshell exercise + Conservative management, Group B: Comparative Group / Frog pump exercises + Conservative management) by lottery method. The participants randomly allocated to Group A will receive conservative treatment along with clamshell exercise. The treatment will start with routine physiotherapy comprised of TENS (setting was in a conventional mode, with a frequency of 80 Hz and a pulse duration of 50-100 μs. The intensity of TENS current was set to produce a strong tingling sensation, but without pain.) A hot pack will be used for 10 minutes and stretching exercises for the whole body as a warm-up, before starting the main treatment regime for 15 minutes. The clamshell starts with lying on the side, with legs stacked and knees bent at a 45-degree angle. Group B will receive conservative treatment along with Frog pump exercise. The treatment will start with routine physiotherapy comprised of TENS (setting was in a conventional mode, with a frequency of 80 Hz and a pulse duration of 50-100 μs. The intensity of TENS current was set to produce a strong tingling sensation, but without pain.) A hot pack will be used for 10 minutes and stretching exercises for the whole body as a warm-up, before starting the main treatment regime for 15 minutes. The Frog pump exercise will start with lying on your back, arms by sides, palms facing down. Data will be assessed by the assessor at baseline, and at the end of the 12th week.

Read the detailed description

Screening: All the participants will be assessed for the eligibility criteria. Patients fulfilling the eligibility criteria will be asked to sign the consent forms before entering them into the study.

Randomization and Allocation: All the screened and willing participants will be randomly allocated into two groups (Group A: Experimental group / Clamshell exercise + Conservative management, Group B: Comparative Group / Frog pump exercises + Conservative management) by lottery method.

Blinding: This study will be a single-blinded study in which the assessor will be blinded.

Intervention Group A: Experimental Group (Clamshell exercise + Conservative management) The participants randomly allocated to Group A will receive conservative treatment along with clamshell exercise. The treatment will start with routine physiotherapy comprised of TENS (setting was in a conventional mode, with a frequency of 80 Hz and a pulse duration of 50-100 μs. The intensity of TENS current was set to produce a strong tingling sensation, but without pain.) A hot pack will be used for 10 minutes and stretching exercises for the whole body as a warm-up, before starting the main treatment regime for 15 minutes. The clamshell starts with lying on the side, with legs stacked and knees bent at a 45-degree angle. Rest the head on the lower arm and use the top arm to steady the frame. Hipbones are stacked on top of one another, as there is a tendency for the top hip to rock backward. Engage the abdominals by pulling your belly button in, as this will help to stabilize the spine and pelvis. Keeping the feet touching, raise the upper knee as high as they can without shifting the hips or pelvis. They don't move their lower leg off the floor. Pause, and then return the upper leg to the starting position on the ground. 20 reps will be done on each side. Each exercise will be performed in 3 sets of 10 repetitions with 1 minute of rest after every exercise set. The whole treatment session will start with 15 min warm-up and end with 5 min cool-down, delivered 3 times a week for 12 weeks yielding a total of 36 sessions within 3 months and the duration of each session will be of 35-45 minutes in Group A.

Group B: Comparative Group (Frog pump exercises + Conservative management) 19 Group B will receive conservative treatment along with Frog pump exercise. The treatment will start with routine physiotherapy comprised of TENS (setting was in a conventional mode, with a frequency of 80 Hz and a pulse duration of 50-100 μs. The intensity of TENS current was set to produce a strong tingling sensation, but without pain.) A hot pack will be used for 10 minutes and stretching exercises for the whole body as a warm-up, before starting the main treatment regime for 15 minutes. The Frog pump exercise will start with lying on your back, arms by sides, palms facing down. Alternatively, make fists with your hands, rest the elbows on the floor, and lift the fists so that your forearms are perpendicular to the floor. Then bend the knees and press the soles of the feet together so that the legs create a "frog legs" or "butterfly" shape. Pressing the outer edges of the feet against the floor, engage the core, and use the glutes to lift the hips. Make sure the shoulders and upper back remain anchored to the floor. Pause, then slowly lower the hips to the floor. . 20 reps will be done on each side. Each exercise will be performed in 3 sets of 10 repetitions with 1 minute of rest after every exercise set. The whole treatment session will start with 15 min warm-up and end with 5 min cool-down, delivered 3 times a week for 12 weeks yielding a total of 36 sessions within 3 months and the duration of each session will be of 35-45 minutes in Group B.

Outcome Variables:

  1. Pain (Numeric Pain Rating Scale)
  2. Range of Motion:(Goniometry)
  3. Functional Disability (Lower Extremity Functional Scale (LEFS)) Data will be assessed by the assessor at baseline, and at the end of the 12th week.
Being tested
Clamshell exercise, Frog pump exercises
Keywords
IT Band Syndrome
Medical subject headings
Iliotibial Band Syndrome

What participants receive

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

  • Clamshell exerciseOther

    The clamshell starts with lying on the side, with legs stacked and knees bent at a 45-degree angle. Rest the head on the lower arm and use the top arm to steady the frame. Hipbones are stacked on top of one another, as there is a tendency for the top hip to rock backward. Engage the abdominals by pulling your belly button in, as this will help to stabilize the spine and pelvis. Keeping the feet touching, raise the upper knee as high as they can without shifting the hips or pelvis. They don't move their lower leg off the floor. Pause, and then return the upper leg to the starting position on the ground. 20 reps will be done on each side. Each exercise will be performed in 3 sets of 10 repetitions with 1 minute of rest after every exercise set.

  • Frog pump exercisesOther

    The Frog pump exercise will start with lying on your back, arms by sides, palms facing down. Alternatively, make fists with your hands, rest the elbows on the floor, and lift the fists so that your forearms are perpendicular to the floor. Then bend the knees and press the soles of the feet together so that the legs create a "frog legs" or "butterfly" shape. Pressing the outer edges of the feet against the floor, engage the core, and use the glutes to lift the hips. Make sure the shoulders and upper back remain anchored to the floor. Pause, then slowly lower the hips to the floor. . 20 reps will be done on each side. Each exercise will be performed in 3 sets of 10 repetitions with 1 minute of rest after every exercise set.

Study groups in NCT07118371
Study groupRoleWhat they receive
Clamshell exerciseExperimentalThe clamshell starts with lying on the side, with legs stacked and knees bent at a 45-degree angle. Rest the head on the lower arm and use the top arm to steady the frame. Hipbones are stacked on top of one another, as there is a tendency for the top hip to rock backward. Engage the abdominals by pulling your belly button in, as this will help to stabilize the spine and pelvis. Keeping the feet touching, raise the upper knee as high as they can without shifting the hips or pelvis. They don't move their lower leg off the floor. Pause, and then return the upper leg to the starting position on the ground. 20 reps will be done on each side. Each exercise will be performed in 3 sets of 10 repetitions with 1 minute of rest after every exercise set.
Receives: Other: Clamshell exercise; Other: Frog pump exercises
Frog pump exercisesExperimentalThe Frog pump exercise will start with lying on your back, arms by sides, palms facing down. Alternatively, make fists with your hands, rest the elbows on the floor, and lift the fists so that your forearms are perpendicular to the floor. Then bend the knees and press the soles of the feet together so that the legs create a "frog legs" or "butterfly" shape. Pressing the outer edges of the feet against the floor, engage the core, and use the glutes to lift the hips. Make sure the shoulders and upper back remain anchored to the floor. Pause, then slowly lower the hips to the floor. . 20 reps will be done on each side. Each exercise will be performed in 3 sets of 10 repetitions with 1 minute of rest after every exercise set.
Receives: Other: Clamshell exercise; Other: Frog pump exercises

What is being measured

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

  1. Numeric Pain Rating Scale)

    Numeric rating scales consist of a series of numbers rating pain intensity, typically from 0 to 10 or 0 to 100, with 0 being "no pain" and 10 or 100 "the worst pain imaginable."

    Measured: 12 weeks

  2. Goniometry)

    A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start9 Sep 2024
  3. Primary completion20 Aug 2025
  4. Study completion15 Sep 2025

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
Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118371
Sponsor's protocol ID
REC-UOL-/241/08/24
Status last verified
Oct 2024
First submitted
10 Dec 2024
Last updated
30 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baik SM, Cynn HS, Shim JH, Lee JH, Shin AR, Lee KE. Effects of Log-Rolling Position on Hip-Abductor Muscle Activation During Side-Lying Hip-Abduction Exercise in Participants With Gluteus Medius Weakness. J Athl Train. 2021 Sep 1;56(9):945-951. doi: 10.4085/306-20.

    PubMed 33150402
  • Taddei UT, Matias AB, Duarte M, Sacco ICN. Foot Core Training to Prevent Running-Related Injuries: A Survival Analysis of a Single-Blind, Randomized Controlled Trial. Am J Sports Med. 2020 Dec;48(14):3610-3619. doi: 10.1177/0363546520969205. Epub 2020 Nov 6.

    PubMed 33156692
  • Mehta SP, Fulton A, Quach C, Thistle M, Toledo C, Evans NA. Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review. J Orthop Sports Phys Ther. 2016 Mar;46(3):200-16. doi: 10.2519/jospt.2016.6165. Epub 2016 Jan 26.

    PubMed 26813750
  • Bolia IK, Gammons P, Scholten DJ, Weber AE, Waterman BR. Operative Versus Nonoperative Management of Distal Iliotibial Band Syndrome-Where Do We Stand? A Systematic Review. Arthrosc Sports Med Rehabil. 2020 Jun 10;2(4):e399-e415. doi: 10.1016/j.asmr.2020.04.001. eCollection 2020 Aug.

    PubMed 32875305
  • Boonstra AM, Stewart RE, Koke AJ, Oosterwijk RF, Swaan JL, Schreurs KM, Schiphorst Preuper HR. Cut-Off Points for Mild, Moderate, and Severe Pain on the Numeric Rating Scale for Pain in Patients with Chronic Musculoskeletal Pain: Variability and Influence of Sex and Catastrophizing. Front Psychol. 2016 Sep 30;7:1466. doi: 10.3389/fpsyg.2016.01466. eCollection 2016.

    PubMed 27746750
  • Charles D, Rodgers C. A LITERATURE REVIEW AND CLINICAL COMMENTARY ON THE DEVELOPMENT OF ILIOTIBIAL BAND SYNDROME IN RUNNERS. Int J Sports Phys Ther. 2020 May;15(3):460-470.

    PubMed 32566382
  • Foch E, Aubol K, Milner CE. Relationship between iliotibial band syndrome and hip neuromechanics in women runners. Gait Posture. 2020 Mar;77:64-68. doi: 10.1016/j.gaitpost.2019.12.021. Epub 2020 Jan 20.

    PubMed 31999979
  • Geisler PR. Current Clinical Concepts: Synthesizing the Available Evidence for Improved Clinical Outcomes in Iliotibial Band Impingement Syndrome. J Athl Train. 2021 Aug 1;56(8):805-815. doi: 10.4085/1062-6050-548-19. Epub 2020 Dec 22.

    PubMed 34375405
  • Guerrero-Tapia H, Martin-Baeza R, Cuesta-Barriuso R. Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study. Int J Environ Res Public Health. 2021 Feb 5;18(4):1528. doi: 10.3390/ijerph18041528.

    PubMed 33562743
  • Hong JH, Kim JS. Diagnosis of iliotibial band friction syndrome and ultrasound guided steroid injection. Korean J Pain. 2013 Oct;26(4):387-91. doi: 10.3344/kjp.2013.26.4.387. Epub 2013 Oct 2.

    PubMed 24156006

Questions about this trial

What is this clinical trial studying?

A study testing Clamshell exercise and Frog pump exercises in people with Iliotibial Band Syndrome, run by University of Lahore 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 7 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 Sep 2025. 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?

Numeric Pain Rating Scale) (time frame: 12 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 NCT07118371, which also lists 10 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 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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