Strain-Counterstrain Treatment of Piriformis Pain

NCT ID: NCT05023005

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-09-30

Brief 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.

Detailed 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.

Conditions

Low Back Pain, Mechanical; Piriformis Syndrome; Somatic Dysfunction of Sacral Region (Finding)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Piriformis Strain-Counterstrain

The treatment group will receive strain-counterstrain for the piriformis muscle.

Group Type: EXPERIMENTAL

Strain-Counterstrain treatment of piriformis muscle

Intervention Type: OTHER

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.

Hamstring Strain-Counterstrain

The sham group will receive strain-counterstrain treatment for the hamstring muscle.

Group Type: SHAM_COMPARATOR

Strain-Counterstrain treatment of piriformis muscle

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mickey Lui

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Locations

Loma Linda University Health

Loma Linda, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roya Vahdatinia, DO

Role: CONTACT

rvahdatinia@llu.edu

9095586202

Mickey Lui, DO

Role: CONTACT

Mickey.Lui@va.gov

9095586202

Facility Contacts

Mickey Lui, MD

Role: primary

909-558-1000

Other Identifiers

5210286

Identifier Type: -

Identifier Source: org_study_id