## Protocol Section
### Identification Module
**NCT ID:** NCT06428136

**Brief Title:** Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function

**Official Title:** Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function

#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/709
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Superior University

#### Responsible Party

**Investigator Affiliation:** Superior University

**Investigator Full Name:** Muhammad Naveed Babur

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Tibial Muscular Dystrophy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 62

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)

**Label:** Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Conservative Treatment (CT)

**Label:** Conservative Treatment (CT)

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)

**Description:** 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

**Name:** Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Conservative Treatment (CT)

**Description:** 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

**Name:** Conservative Treatment (CT)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up.

**Measure:** Measured using a numeric pain rating scale (NPRS)

**Time Frame:** 12 Months

**Description:** Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up

**Measure:** Lower Extremity Functional Scale (LEFS)

**Time Frame:** 12 months

**Description:** Measured using a goniometer at baseline, after intervention, and at 1-month follow-up.

**Measure:** ITBT length

**Time Frame:** 12 months

**Description:** Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up."

**Measure:** Range of motion (ROM):

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

**Maximum Age:** 65 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** The University of Lahore Teaching Hospital

**State:** Punjab

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020966

- Term: Muscular Disorders, Atrophic

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12093

- Name: Muscular Dystrophies

- Relevance: HIGH

- As Found: Muscular Dystrophy

- ID: M26047

- Name: Distal Myopathies

- Relevance: HIGH

- As Found: Tibial Muscular Dystrophy

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M22697

- Name: Muscular Disorders, Atrophic

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T3963

- Name: Muscular Dystrophy

- Relevance: HIGH

- As Found: Muscular Dystrophy

### Condition Browse Module - Meshes

- ID: D000009136

- Term: Muscular Dystrophies

- ID: D000049310

- Term: Distal Myopathies

### Misc Info Module

- Version Holder: 2024-05-31
