Strain-Counterstrain Treatment of Piriformis Pain

Not Applicable

Recruiting

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

• Registration Number: NCT05023005
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Algometer - Change in pressure pain threshold	Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.	Objective improvement in pressure/pain threshold

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States