Clinical trial NCT05023005: Strain-Counterstrain Treatment of Piriformis Pain
Official title: Strain-Counterstrain Treatment of Piriformis Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Piriformis Syndrome
Somatic Dysfunction of Sacral Region (Finding)
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Algometer - Change in pressure pain threshold
timeFrame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Secondary outcomes:
measure: Change in Visual Analog Scale
timeFrame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
measure: Change in Oswestry Disability Index
timeFrame: Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University Health
name: Mickey Lui
role: PRINCIPAL_INVESTIGATOR
References: