## Protocol Section
### Identification Module
**NCT ID:** NCT06437795

**Brief Title:** Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome

**Official Title:** Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome

#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/715
#### 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:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

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

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### 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:** This study aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle, leading to buttock pain and radiating numbness.

**Detailed Description:** The study will recruit participants diagnosed with Piriformis Syndrome and will randomly assign them to receive either dry needling or cupping therapy over a specific period. The primary outcome will be the reduction in pain intensity measured by standardized pain assessment tools. Secondary outcomes will include improvements in functional mobility and quality of life. By analyzing the efficacy and patient-reported outcomes of both therapies, the study aims to provide evidence-based recommendations for clinicians treating Piriformis Syndrome.

### Conditions Module

**Conditions:**

- Piriformis Syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Dry Needling Group

**Label:** Dry Needling Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Cupping Therapy Group

**Label:** Cupping Therapy Group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dry Needling Group

**Description:** Participants in this group will receive dry needling therapy. This involves inserting thin needles into trigger points in the piriformis muscle to relieve pain and muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes.

**Name:** Dry Needling Group

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Cupping Therapy Group

**Description:** Participants in this group will receive cupping therapy. This involves placing cups on the skin to create suction, which is believed to improve blood flow and reduce muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes.

**Name:** Cupping Therapy Group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Participants will rate their pain on a scale from 0 (no pain) to 10 (worst possible pain) at the beginning and end of the study.

**Measure:** Visual Analog Scale (VAS)

**Time Frame:** 12 Months

**Description:** This tool assesses the degree of disability in performing daily activities. Quality of life improvements measured by the SF-36 Health Survey, which evaluates physical and mental health status.

**Measure:** Oswestry Disability Index (ODI)

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults aged between 18 to 65 years.
* Diagnosed with piriformis syndrome.
* Experiencing chronic pain for at least 3 months.
* Willingness to comply with the study protocol and attend all therapy sessions.

Exclusion Criteria:

* Recent surgery on the lower back or hip.
* Presence of systemic diseases affecting muscle function (e.g., multiple sclerosis, rheumatoid arthritis).
* Pregnant or breastfeeding women.
* Use of anticoagulant medication or having a bleeding disorder.
* Participating in another clinical trial simultaneously

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** Ghurkee Hospital

**State:** Punjab

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020426

- Term: Sciatic Neuropathy

- ID: D000020422

- Term: Mononeuropathies

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009408

- Term: Nerve Compression Syndromes

- ID: D000009437

- Term: Neuralgia

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000017699

- Term: Pelvic Pain

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M28404

- Name: Piriformis Muscle Syndrome

- Relevance: HIGH

- As Found: Piriformis Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M22222

- Name: Sciatic Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M22218

- Name: Mononeuropathies

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12352

- Name: Nerve Compression Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M5853

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18092

- Name: Hereditary Sensory and Motor Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: M12381

- Name: Neuralgia

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M19918

- Name: Pelvic Pain

- Relevance: LOW

- As Found: Unknown

- ID: T4568

- Name: Piriformis Syndrome

- Relevance: HIGH

- As Found: Piriformis Syndrome

- ID: T1081

- Name: Charcot-Marie-Tooth Disease

- Relevance: LOW

- As Found: Unknown

- ID: T2761

- Name: Hereditary Motor and Sensory Neuropathy

- Relevance: LOW

- As Found: Unknown

- ID: T2766

- Name: Hereditary Neuropathy With Liability to Pressure Palsies

- Relevance: LOW

- As Found: Unknown

- ID: T5067

- Name: Roussy Levy Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055958

- Term: Piriformis Muscle Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M2340

- Name: Acetaminophen

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
