Strain-Counterstrain Treatment of Piriformis Pain

NCT05023005 | Recruiting

• 1 other identifier: 5210286
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Visual Analog Scale

  Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.

• Change in Oswestry Disability Index

  Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).

Study Arms (2)

Piriformis Strain-Counterstrain

EXPERIMENTAL

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

Other: Strain-Counterstrain treatment of piriformis muscle

Hamstring Strain-Counterstrain

SHAM COMPARATOR

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

Other: Strain-Counterstrain treatment of piriformis muscle

Interventions

Strain-Counterstrain treatment of piriformis muscle 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; Piriformis Strain-Counterstrain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Piriformis Muscle Syndrome; Signs and Symptoms

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pelvic Pain

Study Officials

• Mickey Lui

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roya Vahdatinia, DO

CONTACT

9095586202; rvahdatinia@llu.edu

Mickey Lui, DO

CONTACT

9095586202; Mickey.Lui@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will not know the true positioning for strain counterstrain treatment of piriformis muscle versus hamstring muscle.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 26, 2021
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)