NCT06437795

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 25, 2024

Last Update Submit

May 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale (VAS)

    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.

    12 Months

  • Oswestry Disability Index (ODI)

    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.

    12 months

Study Arms (2)

Dry Needling Group

EXPERIMENTAL
Diagnostic Test: Dry Needling Group

Cupping Therapy Group

OTHER
Other: Cupping Therapy Group

Interventions

Dry Needling GroupDIAGNOSTIC_TEST

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.

Dry Needling Group

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.

Cupping Therapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurkee Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2024

First Posted

May 31, 2024

Study Start

November 1, 2023

Primary Completion

May 1, 2024

Study Completion

September 1, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations