Low Back Pain, MechanicalNCT05023005
Strain-Counterstrain Treatment of Piriformis Pain
A study testing Strain-Counterstrain treatment of piriformis muscle in people with Low Back Pain, Mechanical and Piriformis Syndrome, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical, Piriformis Syndrome, Somatic Dysfunction of Sacral Region (Finding)
- What is being tested?
- Strain-Counterstrain treatment of piriformis muscle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Tender point (or trigger point) in piriformis muscle determined by physical exam
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Health
Loma Linda, California, 92350
Mickey Lui, MD, 909-558-1000
About this study
The purpose of this investigator-initiated study is to provide an efficient and non-invasive treatment option for pain caused by the piriformis muscle.
Read the 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)
- Being tested
- Strain-Counterstrain treatment of piriformis muscle
- Medical subject headings
- Low Back Pain, Piriformis Muscle Syndrome, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain-Counterstrain treatment of piriformis muscleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Piriformis Strain-Counterstrain | Experimental | The treatment group will receive strain-counterstrain for the piriformis muscle. Receives: Other: Strain-Counterstrain treatment of piriformis muscle |
| Hamstring Strain-Counterstrain | Sham comparator | The sham group will receive strain-counterstrain treatment for the hamstring muscle. Receives: Other: Strain-Counterstrain treatment of piriformis muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometer - Change in pressure pain threshold
Objective improvement in pressure/pain threshold
Measured: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Secondary outcomes (2)
Change in Visual Analog Scale
Subjective improvement in low back/leg pain
Measured: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Change in Oswestry Disability Index
Assesses pain with doing different activities (sleeping, walking, sitting, etc), assesses ability to do activities of daily living
Measured: Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickey Lui, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023005
- Sponsor's protocol ID
- 5210286
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain-Counterstrain Treatment of Piriformis Pain
- ClinicalTrials.gov ID
- NCT05023005
- Acronym / sponsor ID
- 5210286
- Conditions
- Low Back Pain, Mechanical, Piriformis Syndrome, Somatic Dysfunction of Sacral Region (Finding)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Piriformis Strain-Counterstrain | Experimental | Other: Strain-Counterstrain treatment of piriformis muscleThe treatment group will receive strain-counterstrain for the piriformis muscle. |
| Hamstring Strain-Counterstrain | Sham comparator | Other: Strain-Counterstrain treatment of piriformis muscleThe sham group will receive strain-counterstrain treatment for the hamstring muscle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 65 years of age
- Tender point (or trigger point) in piriformis muscle determined by physical exam
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strain-Counterstrain treatment of piriformis muscleParticipant 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. | Other | Hamstring Strain-Counterstrain, Piriformis Strain-Counterstrain |
Primary outcome
Algometer - Change in pressure pain threshold
Time frame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Objective improvement in pressure/pain threshold
2 secondary outcomes
Change in Visual Analog Scale
Time frame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.
Change in Oswestry Disability Index
Time frame: Before first treatment and after second treatment. Each treatment is 1-2 weeks apart (anticipated).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain, Mechanical
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mickey Lui principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strain-Counterstrain treatment of piriformis muscle in people with Low Back Pain, Mechanical and Piriformis Syndrome, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roya Vahdatinia, DO (9095586202, rvahdatinia@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algometer - Change in pressure pain threshold (time frame: Pre and post each treatment. There are 2 treatments, 1-2 weeks apart from one another.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.