Tibial Muscular DystrophyNCT06428136
Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function
A study testing Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) and Conservative Treatment (CT) in people with Tibial Muscular Dystrophy, run by Superior University at 1 site in Pakistan.
Trial summary
Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Tibial Muscular Dystrophy
- What is being tested?
- Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) and Conservative Treatment (CT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 1 Sep 2024
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 45-65 years old (Jeong et al., 2019)
- Both genders will be included (Jeong et al., 2019)
- Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
- Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)
Who cannot join
- Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
- Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
- Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
- Neurological conditions affecting leg function (Peterson et al., 2022)
- Pregnancy (Jeong et al., 2019)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Lahore Teaching Hospital
Lahore, Punjab Province
About this study
Official title: Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function
Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.
Read the detailed description
There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band.
- Conditions
- Tibial Muscular Dystrophy
- Being tested
- Clamshell exercises with Electrical Muscle Stimulation (CT + EMS), Conservative Treatment (CT)
- Medical subject headings
- Distal Myopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)Diagnostic test
Side-lying clamshells: 3 sets of 10 repetitions per leg, 3 times per week Hip abduction with theraband: 3 sets of 10 repetitions per leg, 3 times per week Bridge with hip abduction: 3 sets of 10 repetitions per leg, 3 times per week
Electrical muscle stimulation:
Applied to the gluteus medius and minimus muscles for 20 minutes per session, 3 times per week Frequency and intensity adjusted to individual tolerance
Conservative Treatment (CT)Other
Stretching: Iliotibial band stretch: 30-second hold, 3 repetitions per leg, 2 times per day Quadriceps stretch: 30-second hold, 3 repetitions per leg, 2 times per day Hamstring stretch: 30-second hold, 3 repetitions per leg, 2 times per day
| Study group | Role | What they receive |
|---|---|---|
| Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) | Experimental | Not described Receives: Diagnostic Test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) |
| Conservative Treatment (CT) | Other | Not described Receives: Other: Conservative Treatment (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured using a numeric pain rating scale (NPRS)
ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up.
Measured: 12 Months
Lower Extremity Functional Scale (LEFS)
Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up
Measured: 12 months
ITBT length
Measured using a goniometer at baseline, after intervention, and at 1-month follow-up.
Measured: 12 months
Range of motion (ROM):
Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up."
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428136
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/709
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function
- ClinicalTrials.gov ID
- NCT06428136
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/709
- Conditions
- Tibial Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.
Detailed description
There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) | Experimental | Diagnostic Test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) |
| Conservative Treatment (CT) | Other | Other: Conservative Treatment (CT) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 45-65 years old (Jeong et al., 2019)
- Both genders will be included (Jeong et al., 2019)
- Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
- Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)
Key exclusion criteria (5 listed)
- Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
- Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
- Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
- Neurological conditions affecting leg function (Peterson et al., 2022)
- Pregnancy (Jeong et al., 2019)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)Side-lying clamshells: 3 sets of 10 repetitions per leg, 3 times per week Hip abduction with theraband: 3 sets of 10 repetitions per leg, 3 times per week Bridge with hip abduction: 3 sets of 10 repetitions per leg, 3 times per week Electrical muscle stimulation: Applied to the gluteus medius and minimus muscles for 20 minutes per session, 3 times per week Frequency and intensity adjusted to individual tolerance | Diagnostic test | Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) |
| Conservative Treatment (CT)Stretching: Iliotibial band stretch: 30-second hold, 3 repetitions per leg, 2 times per day Quadriceps stretch: 30-second hold, 3 repetitions per leg, 2 times per day Hamstring stretch: 30-second hold, 3 repetitions per leg, 2 times per day | Other | Conservative Treatment (CT) |
Primary outcome
Measured using a numeric pain rating scale (NPRS)
Time frame: 12 Months
ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up.
Lower Extremity Functional Scale (LEFS)
Time frame: 12 months
Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up
ITBT length
Time frame: 12 months
Measured using a goniometer at baseline, after intervention, and at 1-month follow-up.
Range of motion (ROM):
Time frame: 12 months
Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up."
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) and Conservative Treatment (CT) in people with Tibial Muscular Dystrophy, run by Superior University 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 May 2024. 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?
Results are not available in the source record.
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?
Measured using a numeric pain rating scale (NPRS) (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2024.