- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07118371
- Original Trial
Clamshell and Frog Pump Exercises on Pain, Range of Motion, and Functional Disability
Effects of Clamshell and Frog Pump Exercises on Pain, Range of Motion, and Functional Disability in Long-standing Sales Workers With Iliotibial Band Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Pain (Numeric Pain Rating Scale)
- Range of Motion:(Goniometry)
- Functional Disability (Lower Extremity Functional Scale (LEFS)) Data will be assessed by the assessor at baseline, and at the end of the 12th week.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 55150
- University of Lahore Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clamshell exercise
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 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 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.
|
|
Experimental: Frog pump exercises
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 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale)
Time Frame: 12 weeks
|
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."
|
12 weeks
|
|
Goniometry)
Time Frame: 12 weeks
|
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position.
|
12 weeks
|
|
Lower Extremity Functional Scale (LEFS)
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waqar Ul Hassan, MS-MSK, University of Lahore
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-UOL-/241/08/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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