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Clinical Trials/NCT07118371
NCT07118371CompletedNot Applicable

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

University of Lahore1 site in 1 country92 target enrollmentStarted: September 9, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
92
Locations
1
Primary Endpoint
Numeric Pain Rating Scale)

Study Overview

Brief 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. 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Clamshell exercise

Experimental

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.

Intervention: Frog pump exercises (Other)

Clamshell exercise

Experimental

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.

Intervention: Clamshell exercise (Other)

Frog pump exercises

Experimental

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.

Intervention: Clamshell exercise (Other)

Frog pump exercises

Experimental

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.

Intervention: Frog pump exercises (Other)

Outcomes

Primary Outcomes

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."

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Lahore
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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