Strain-Counterstrain Treatment for Piriformis Syndrome

Overseen By Mickey Lui, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Active cancer, Pregnant, Lumbar radiculopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2-4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a non-invasive treatment called Strain-Counterstrain, targeting the piriformis muscle to relieve pain from piriformis syndrome. Participants will receive either the actual treatment on the piriformis muscle or a sham treatment on the hamstring for comparison. Ideal candidates for this trial are individuals with a tender or trigger point in their piriformis muscle, identified during a physical exam. As an unphased trial, this study offers participants the chance to contribute to innovative research that may lead to new pain relief methods.

Do I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Strain-Counterstrain treatment is safe for the piriformis muscle?

Research shows that strain-counterstrain treatment is generally easy for patients to handle. This method, also called positional release, involves gently moving the body to ease muscle pain. Studies have not found any major side effects, making it a safe choice for most people. It offers a hands-on approach to relieve muscle and bone discomfort without surgery or injections. Since strain-counterstrain is already used for other muscle problems, current practices support its safety. Participants considering this trial can feel confident about the treatment's safety based on its current use and research findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Strain-Counterstrain treatment for piriformis syndrome because it offers a non-invasive and targeted approach to relieving muscle pain. Unlike standard treatments like physical therapy, anti-inflammatory medications, or corticosteroid injections, this technique involves gently positioning the body to alleviate the stress on the piriformis muscle, potentially reducing pain without medication. This method might provide a safer alternative for those unable to take medications and could offer quicker relief compared to traditional therapies. Overall, it represents a promising new way to manage muscle-related pain with minimal side effects.

What evidence suggests that Strain-Counterstrain treatment might be an effective treatment for piriformis syndrome?

Research has shown that strain-counterstrain treatment can effectively reduce pain from the piriformis muscle. This trial will compare two applications of strain-counterstrain: one targeting the piriformis muscle and another targeting the hamstring muscle as a sham comparator. This method has shown promise in easing discomfort and increasing movement in patients with similar issues. In cases of sudden low back pain, strain-counterstrain has proven effective on its own, indicating it might help with muscle-related pain. For those with piriformis syndrome, this treatment could reduce tender spots by up to 70%, helping to relieve pain and improve movement. These findings suggest that strain-counterstrain could be a useful option for managing piriformis syndrome. ^{1 2 6 7 8}

Who Is on the Research Team?

Mickey Lui, MD

Principal Investigator

Loma Linda University Health

Are You a Good Fit for This Trial?

This trial is for people aged 18-65 with lower back pain specifically from the piriformis muscle, confirmed by a physical exam. Participants must speak English and be able to attend two sessions in one month. It's not for pregnant individuals, those with certain back conditions like lumbar radiculopathy or spondylolisthesis, or those receiving other treatments like massage during the study.

Inclusion Criteria

I have a sore spot in my buttock muscle found during an exam.

Exclusion Criteria

I cannot lay face down.

Pregnant

I cannot attend two sessions in the same month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive strain-counterstrain treatment for the piriformis or hamstring muscle, with two treatments 1-2 weeks apart

2-4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in pain and disability using questionnaires and algometer measurements

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Strain-Counterstrain treatment of piriformis muscle

Trial Overview The trial is testing Strain-Counterstrain treatment on the piriformis muscle as a non-invasive way to relieve lower back pain. This technique involves finding tender points and using specific positions to alleviate discomfort.

How Is the Trial Designed?

Group I: Piriformis Strain-Counterstrain Experimental Treatment 1 Intervention

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

Group II: Hamstring Strain-Counterstrain Placebo Group 1 Intervention

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

Strain-Counterstrain treatment of piriformis muscle is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Strain-Counterstrain for:

• Piriformis syndrome
• Sciatica
• Musculoskeletal pain
• Neuromuscular dysfunction

Approved in European Union as Strain-Counterstrain for:

• Piriformis syndrome
• Sciatica
• Chronic pain
• Fibromyalgia
• Musculoskeletal pain

Approved in Canada as Strain-Counterstrain for:

• Piriformis syndrome
• Sciatica
• Musculoskeletal pain
• Neuromuscular dysfunction

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

A case study of a man in his late 40s with piriformis syndrome showed that a botulinum toxin (BoNT) injection significantly relieved his pain, lasting for 2 years after the second injection.

The study suggests that increasing the dilution volume of the BoNT injection may enhance its therapeutic effectiveness for treating piriformis syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin injection strategy of intractable and relapsed piriformis syndrome: A case report. Kwon, SY., Jun, EH., Park, SJ., et al.[2022]

A single strain-counterstrain intervention did not significantly improve cervical range of motion compared to a sham treatment in 61 patients with neck pain, with only a 1.5% difference in mobility restriction after treatment.

Both groups showed improvement after receiving full individualized osteopathic treatment, suggesting that the overall osteopathic approach may be more effective than strain-counterstrain alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strain-counterstrain to treat restrictions of the mobility of the cervical spine in patients with neck pain: a sham-controlled randomized trial. Klein, R., Bareis, A., Schneider, A., et al.[2022]

In a study involving 60 patients with mechanical neck pain, the addition of the Strain-counterstrain technique (SCS) to standard therapy significantly improved pain levels, pressure pain thresholds, and disability scores compared to standard therapy alone.

The results suggest that SCS is an effective treatment method for enhancing recovery in patients with mechanical neck pain, supporting its use in clinical practice to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of adding strain-counterstrain to standard therapy on axioscapular muscles amplitude and fatigue in mechanical neck pain: a single-blind, randomized trial. El-Khateeb, YS., Mahmoud, AG., Mohamed, MH., et al.[2023]

The strain and counterstrain (SCS) technique showed promising results in reducing pain and improving function in 19 out of 20 patients with chronic myofascial pain who had not responded to standard treatments, with improvements ranging from 50% to 100%.

After SCS therapy, 11 of the 20 patients maintained partial improvement for 6 months, and 4 patients reported being pain-free, suggesting that SCS could be a valuable adjunctive therapy for chronic pain disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofascial pain unresponsive to standard treatment: successful use of a strain and counterstrain technique with physical therapy. Dardzinski, JA., Ostrov, BE., Hamann, LS.[2019]

Strain counterstrain (SCS) technique shows a statistically significant reduction in tender point palpation pain compared to control conditions, based on a meta-analysis of five randomized control trials.

The overall quality of evidence for SCS's effectiveness is low, indicating a need for higher-quality studies with larger sample sizes to better assess long-term outcomes related to pain and dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strain counterstrain technique to decrease tender point palpation pain compared to control conditions: a systematic review with meta-analysis. Wong, CK., Abraham, T., Karimi, P., et al.[2022]

In a study involving 40 patients with piriformis syndrome, post-facilitation stretching was found to be more effective than ELDOA in reducing pain and improving muscle length and functional performance over a 6-week treatment period.

Patients in the post-facilitation group showed significant improvements in pain levels, piriformis muscle length, straight leg raise ability, and lower extremity function compared to those receiving ELDOA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ELDOA and post-facilitation stretching technique on pain and functional performance in patients with piriformis syndrome: A randomized controlled trial. Shahzad, M., Rafique, N., Shakil-Ur-Rehman, S., et al.[2021]

Strain counterstrain is a developing osteopathic technique, and recent research is beginning to explore its physiological mechanisms and clinical effects.

The master class provides clinical application guidelines and specific treatment strategies for various key clinical scenarios, indicating its practical relevance in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strain counterstrain: current concepts and clinical evidence. Wong, CK.[2022]

Piriformis syndrome, which causes sciatica-like symptoms due to compression of the sciatic nerve by the piriformis muscle, is more commonly diagnosed in females and can lead to tingling, numbness, and pain.

Various physiotherapy techniques, including nerve mobilization and stretching, have been shown to effectively manage piriformis syndrome, with nerve gliding techniques causing less strain on the nerve compared to tensioning techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapy for Piriformis Syndrome Using Sciatic Nerve Mobilization and Piriformis Release. Ahmad Siraj, S., Dadgal, R.[2023]

Ultrasound-guided dry needling is proposed as a novel treatment approach for piriformis syndrome, which is caused by the compression of the sciatic nerve under the piriformis muscle.

This method offers a different perspective compared to traditional treatments like physical therapy, stretching, and injections, potentially providing effective relief for patients suffering from this painful condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new treatment modality in piriformis syndrome: Ultrasound guided dry needling treatment. Bağcıer, F., Tufanoğlu, FH.[2021]

The study identified optimal injection sites for botulinum neurotoxin in the piriformis muscle, based on nerve distribution patterns observed in 15 specimens, which can enhance treatment efficacy.

Clinicians can use these guidelines to improve the effectiveness of various injection treatments (like steroids and anesthetics) while minimizing the risk of adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for botulinum neurotoxin injections in piriformis syndrome. Yi, KH., Lee, KL., Lee, JH., et al.[2021]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK563189/

Osteopathic Manipulative Treatment: Muscle Energy ... - NCBI Muscle energy and counterstrain technique are two of the modalities used in a larger group of treatments known as osteopathic manipulative treatments (OMT).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6385547/

Effect of muscle energy technique with and without strain– ... Muscle energy technique (MET) and strain–counterstrain (SCS) technique are found to be effective as a sole treatment of acute low back pain (LBP).

3. jneonatalsurg.com jneonatalsurg.com/index.php/jns/article/download/6865/5887/22626

Effects Of Positional Release Technique and ... The patient's symptoms dramatically improved, including a decrease in discomfort and an increase in lower limb activities and hip range of motion.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05023005

Strain-Counterstrain Treatment of Piriformis Pain 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% ...

5. researchgate.net researchgate.net/publication/392609782_Comparative_Effects_of_Post-Isometric_Relaxation_Technique_and_Strain_Counterstrain_in_Patients_with_Piriformis_Syndrome

(PDF) Comparative Effects of Post-Isometric Relaxation ... Conclusion: Post-isometric relaxation demonstrated superior efficacy in reducing pain, improving range of motion, and enhancing functional recovery in patients ...

6. counterstrain.com counterstrain.com/wp-content/uploads/2018/09/Wong-Strain-Counterstrain-Current-Concepts-Article.pdf

Strain counterstrain: Current concepts and clinical evidence Also known as positional release, SCS is a passive positional technique aimed at relieving musculoskeletal pain and dysfunction through indirect manual.

7. researchgate.net researchgate.net/publication/264832772_The_effectiveness_of_strain_counterstrain_in_the_treatment_of_patients_with_chronic_ankle_instability_A_randomized_clinical_trial

The effectiveness of strain counterstrain in the treatment ... Preliminary evidence suggests that SCS may lead to an improvement in dynamic ankle stability and the subjective sense of ankle instability.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK562152/

Physiology, Counterstrain and Facilitated Positional Release ... This technique can shorten the 90-second treatment interval to only about 5 seconds. However, FPR requires a 3-plane diagnosis instead of ...