Strain-Counterstrain Treatment of Piriformis Pain

Low Back Pain, Mechanical Clinical Trial

Official title:

Strain-Counterstrain Treatment of Piriformis Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023005
• Other study ID #: 5210286
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Loma Linda University
• Contact: Roya Vahdatinia, DO
• Phone: 9095586202
• Email: rvahdatinia[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigator-initiated study is to provide an efficient and non-invasive treatment option for pain caused by the piriformis muscle.

Description:

There are two arms to the study: treatment and sham. The treatment group will receive strain-counterstrain for the piriformis muscle. The sham group will receive strain-counterstrain treatment for the hamstring muscle. There will be two treatments, 1-2 weeks apart ideally. Participants will fill out the Oswestry Disability Index Questionnaire before the first treatment and after the second treatment (which is 1-2 weeks after the first treatment). Participants will also identify pain using the Visual Analog Scale (VAS) before and after each treatment. Participants will identify pain at rest prior to treatment using VAS. Participant will then identify pain at the start of treatment while pressure is applied to the piriformis muscle (4.5kg/cm2) and post treatment while pressure is applied to the piriformis muscle (4.5 kg/cm2). An algometer will be used pre and post each treatment (2 treatments that are 1-2 weeks apart) to objectively measure any change in pain pressure threshold.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years of age
• Tender point (or trigger point) in piriformis muscle determined by physical exam

Exclusion criteria:

• Less than 45 degrees of active hip flexion, less than 5 degrees of active hip internal rotation or less than 30 degrees of active hip external rotation, on side of affected piriformis
• Unable to lay prone
• Non-English speaker
• Inability to attend 2 sessions within the same month
• Active cancer
• Pregnant
• Diagnosis of lumbar radiculopathy
• Greater than grade 1 lumbar spondylolisthesis
• Presence of lumbar region Pars Defect
• Receiving massage, acupuncture, chiropractic treatments, osteopathic treatments during study period.

Related Conditions & MeSH terms

• Low Back Pain
• Low Back Pain, Mechanical
• Piriformis Muscle Syndrome
• Piriformis Syndrome

Intervention

Other:
• Strain-Counterstrain treatment of piriformis muscle
Participant will lay prone on table with affected leg close to edge of table. Piriformis muscle tender point is identified and palpated. Then patient leg is passively moved off table and passive hip flexion, abduction, and possible internal/external rotation is added to reduce tender point by 70% or more. This is done passively. This position is held for 90 seconds and then participant is passively returned back to neutral prone position with leg on table. Tender point is palpated again to reassess for change in pain (using subjective visual analog scale). An algometer is also used pre and post to assess objective change in pressure pain threshold.

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algometer - Change in pressure pain threshold	Objective improvement in pressure/pain threshold	Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Secondary	Change in Visual Analog Scale	Subjective improvement in low back/leg pain	Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Secondary	Change in Oswestry Disability Index	Assesses pain with doing different activities (sleeping, walking, sitting, etc), assesses ability to do activities of daily living	Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).