Low Back PainNCT07094997
Massage Therapy for Healthcare Staff
A study testing Guidline-basaed massage therapy and Swedish massage in people with Low Back Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
The piriformis muscle can be a contributing factor to low back pain (LBP) due to its anatomical proximity to the sciatic nerve and sacroiliac joint. When the piriformis becomes tight or irritated, it may compress or irritate the sciatic nerve-a condition often referred to as piriformis syndrome-leading to pain that… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Guidline-basaed massage therapy and Swedish massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 31 Jul 2025to Mar 2026
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult healthcare workers
- Aged 30-65 years with chronic nonspecific low back pain for ≥3 months
- No medical contraindications to massage therapy
- Body mass index (BMI) between 18.5 and 25 kg/m²
- Provided written informed consent
Who cannot join
- Massage therapy within the past 3 months
- Contraindications to massage therapy
- Ongoing physical therapy
- Significant medical or psychiatric conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, Lower Silesian Voivodeship
Agnieszka Dębiec-Bąk, Professor, +48 71 347 3537, agnieszka.debiec-bak@awf.wroc.pl
About this study
Official title: Effectiveness of Massage Therapy Among Healthcare Workers Suffering From Low Back Pain - a Randomized Controlled Trial
The piriformis muscle can be a contributing factor to low back pain (LBP) due to its anatomical proximity to the sciatic nerve and sacroiliac joint. When the piriformis becomes tight or irritated, it may compress or irritate the sciatic nerve-a condition often referred to as piriformis syndrome-leading to pain that radiates from the lower back to the buttock and down the leg.
The goal of this clinical trial is to examine the effectiveness of massage therapy in counteracting symptoms of low back pain (LBP) among healthcare workers. The main question it aims to answer is:
Read more
- Can massage of the piriformis muscle and related musculature effectively reduce symptoms in individuals experiencing LBP linked to myofascial or neuromuscular dysfunction?
Massage therapy targeting the piriformis and associated muscles (e.g., gluteus maximus, medius, and deep hip rotators) can help by:
- Reducing muscle tension and spasms,
- Improving local blood circulation,
- Alleviating pressure on the sciatic nerve,
- Restoring hip mobility and muscle balance.
Read the detailed description
Background and Rationale Low back pain (LBP) is a prevalent musculoskeletal condition, particularly among healthcare workers due to occupational stress and physical demands. The piriformis muscle, located in the deep gluteal region, plays a crucial role in hip stabilization and external rotation. Due to its anatomical proximity to the sciatic nerve and sacroiliac joint, hypertonicity or irritation of the piriformis muscle may lead to compression of the sciatic nerve-a condition clinically recognized as piriformis syndrome-which manifests as radiating pain from the lower back through the buttock and into the posterior thigh and leg.
Myofascial and neuromuscular dysfunctions of the piriformis and surrounding musculature (including the gluteus maximus, gluteus medius, and deep lateral rotators) are increasingly implicated in chronic, nonspecific LBP. Massage therapy interventions targeting these soft tissue structures may reduce neuromuscular hyperactivity, restore muscular balance, and decrease nociceptive input. However, there is limited high-quality evidence evaluating the comparative effectiveness of professional massage therapy alone versus in combination with self-massage techniques for addressing piriformis-related LBP.
Additionally, there is no standardized approach based on guidelines developed by medical associations. There is a clear need to formulate and evaluate evidence-based protocols for the management of low back pain (LBP). This study will focus on implementing and assessing guidelines provided by the Polish Society of Physiotherapy, the Polish Society of Family Medicine, and European rural health organizations.
Techniques used during the intervention include targeted soft tissue mobilization focused on:
- Piriformis
- Gluteus maximus and medius
- Obturator internus/externus
- Quadratus femoris
Introducing self-massage as a complementary component to professional massage therapy is essential for sustaining and enhancing therapeutic outcomes in the management of low back pain. While manual therapy sessions provide targeted relief by reducing muscle tension, improving circulation, and alleviating nerve compression, these effects can be transient without ongoing maintenance. Self-massage empowers patients to actively participate in their own care by enabling regular myofascial release and muscle relaxation outside the clinical setting. This continued intervention helps prevent the recurrence of muscle tightness and neuromuscular dysfunction, promotes long-term improvements in tissue flexibility and blood flow, and supports sustained pain reduction and functional restoration. Incorporating self-massage training into treatment protocols fosters patient autonomy, improves adherence to therapy, and ultimately contributes to more durable and meaningful clinical benefits.
In the study researchers try to evaluate the effectiveness of guideline-based massage therapy alone versus guideline-based massage therapy combined with self-massage training, compared to a control group, in improving pain, function, and overall well-being in individuals with a low back pain.
Patients participating in this research on massage and self-massage for low back pain (LBP) can experience several important benefits. Firstly, they may gain access to specialized, guideline-based manual therapy delivered by licensed professionals, which can help reduce pain intensity, relieve muscle tension, and improve mobility in the lower back and hip region. Additionally, those in the self-massage group will acquire practical skills and knowledge to manage their symptoms independently, empowering them with effective techniques to maintain and prolong therapeutic effects between treatment sessions. Participation also offers close monitoring of their condition through regular assessments, which may lead to personalized adjustments in care. Beyond physical improvements, engaging in the study can enhance overall well-being and function, potentially reducing work-related disability and improving quality of life. Finally, contributing to this research advances scientific understanding of effective LBP treatments, potentially benefiting broader patient populations in the future.
- Conditions
- Low Back Pain
- Being tested
- Guidline-basaed massage therapy, Swedish massage
- Keywords
- Randomiezed controlled trial, Massage therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidline-basaed massage therapyOther
Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners
Swedish massageOther
A classical form of therapeutic massage that uses a combination of long, flowing strokes, kneading, friction, tapping, and gentle stretching to promote relaxation, improve circulation, and reduce muscle tension. It is typically performed using oil or lotion to reduce friction on the skin. Techniques are applied with light to moderate pressure and are designed to enhance general well-being and support recovery from muscular discomfort or stress
| Study group | Role | What they receive |
|---|---|---|
| Guideline-Based Massage Therapy + Self-Massage Group (GMT+SM) | Experimental | GMT+SM - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists.
Self-Massage Training:
One in-person instructional session, plus take-home materials (videos and printed instructions). Receives: Other: Guidline-basaed massage therapy |
| Guideline-Based Massage Therapy (GMT) | Experimental | GMT - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists. Receives: Other: Guidline-basaed massage therapy |
| Control group (CG) | Active comparator | Participants receive Swedish massage Receives: Other: Swedish massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scale
Visual Analogue Scale (VAS) is a continuous scale consisting of a horizontal line, 100 mm long, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). VAS is frequently used to determine the effectiveness of treatment as an outcome measure. Most studies show that VAS is a valid and reliable scale.
Measured: From enrollment to the end of treatment at 2 weeks
ODI
The ODI (Oswestry Disability Index) is a standardized questionnaire used to measure a patient's level of disability due to lower back pain. It assesses how back pain affects a person's ability to manage everyday life.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (2)
Thermography
Thermal images taken before and after a massage session can be used to observe temperature changes in specific body areas. An increase in surface temperature is often interpreted as a sign of enhanced blood flow, vasodilation, and localized circulation improvement - all considered typical outcomes of massage.
Measured: From enrollment to the end of treatment at 2 weeks
Doppler USG
Doppler ultrasound is used to assess blood flow in vessels by measuring changes in the frequency of sound waves reflected from moving red blood cells. Velocity and direction of blood flow can be visualized and quantified in real time. Abnormalities such as blockages, narrowing, or turbulence can be detected without the need for invasive procedures. Color and spectral Doppler modes are typically employed to provide detailed flow information. This method is widely considered a reliable, non-invasive tool in vascular diagnostics. In this project arteria glutea superior and inferior will be assessed.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Jul 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Prospective, three-arm, parallel-group, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Kassolik, Phd, Wroclaw University of Health and Sport Sciences
- Investigators
- Krzysztof K Principal Investigator, Principal investigator, Department of Massage and Physiotherapy, Wroclaw University of Health and Sport Sciences, Wroclaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094997
- Sponsor's protocol ID
- Massage for healthcare staff
- Status last verified
- Feb 2026
- First submitted
- 29 Jul 2025
- Last updated
- 24 Feb 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Massage Therapy Among Healthcare Workers Suffering From Low Back Pain - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07094997
- Acronym / sponsor ID
- Massage for healthcare staff
- Conditions
- Low Back Pain
- Keywords
- Randomiezed controlled trial, Massage therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Jul 2025 (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 piriformis muscle can be a contributing factor to low back pain (LBP) due to its anatomical proximity to the sciatic nerve and sacroiliac joint. When the piriformis becomes tight or irritated, it may compress or irritate the sciatic nerve-a condition often referred to as piriformis syndrome-leading to pain that radiates from the lower back to the buttock and down the leg.
The goal of this clinical trial is to examine the effectiveness of massage therapy in counteracting symptoms of low back pain (LBP) among healthcare workers. The main question it aims to answer is:
- Can massage of the piriformis muscle and related musculature effectively reduce symptoms in individuals experiencing LBP linked to myofascial or neuromuscular dysfunction?
Massage therapy targeting the piriformis and associated muscles (e.g., gluteus maximus, medius, and deep hip rotators) can help by:
- Reducing muscle tension and spasms,
- Improving local blood circulation,
- Alleviating pressure on the sciatic nerve,
- Restoring hip mobility and muscle balance.
Detailed description
Background and Rationale Low back pain (LBP) is a prevalent musculoskeletal condition, particularly among healthcare workers due to occupational stress and physical demands. The piriformis muscle, located in the deep gluteal region, plays a crucial role in hip stabilization and external rotation. Due to its anatomical proximity to the sciatic nerve and sacroiliac joint, hypertonicity or irritation of the piriformis muscle may lead to compression of the sciatic nerve-a condition clinically recognized as piriformis syndrome-which manifests as radiating pain from the lower back through the buttock and into the posterior thigh and leg.
Myofascial and neuromuscular dysfunctions of the piriformis and surrounding musculature (including the gluteus maximus, gluteus medius, and deep lateral rotators) are increasingly implicated in chronic, nonspecific LBP. Massage therapy interventions targeting these soft tissue structures may reduce neuromuscular hyperactivity, restore muscular balance, and decrease nociceptive input. However, there is limited high-quality evidence evaluating the comparative effectiveness of professional massage therapy alone versus in combination with self-massage techniques for addressing piriformis-related LBP.
Additionally, there is no standardized approach based on guidelines developed by medical associations. There is a clear need to formulate and evaluate evidence-based protocols for the management of low back pain (LBP). This study will focus on implementing and assessing guidelines provided by the Polish Society of Physiotherapy, the Polish Society of Family Medicine, and European rural health organizations.
Techniques used during the intervention include targeted soft tissue mobilization focused on:
- Piriformis
- Gluteus maximus and medius
- Obturator internus/externus
- Quadratus femoris
Introducing self-massage as a complementary component to professional massage therapy is essential for sustaining and enhancing therapeutic outcomes in the management of low back pain. While manual therapy sessions provide targeted relief by reducing muscle tension, improving circulation, and alleviating nerve compression, these effects can be transient without ongoing maintenance. Self-massage empowers patients to actively participate in their own care by enabling regular myofascial release and muscle relaxation outside the clinical setting. This continued intervention helps prevent the recurrence of muscle tightness and neuromuscular dysfunction, promotes long-term improvements in tissue flexibility and blood flow, and supports sustained pain reduction and functional restoration. Incorporating self-massage training into treatment protocols fosters patient autonomy, improves adherence to therapy, and ultimately contributes to more durable and meaningful clinical benefits.
In the study researchers try to evaluate the effectiveness of guideline-based massage therapy alone versus guideline-based massage therapy combined with self-massage training, compared to a control group, in improving pain, function, and overall well-being in individuals with a low back pain.
Patients participating in this research on massage and self-massage for low back pain (LBP) can experience several important benefits. Firstly, they may gain access to specialized, guideline-based manual therapy delivered by licensed professionals, which can help reduce pain intensity, relieve muscle tension, and improve mobility in the lower back and hip region. Additionally, those in the self-massage group will acquire practical skills and knowledge to manage their symptoms independently, empowering them with effective techniques to maintain and prolong therapeutic effects between treatment sessions. Participation also offers close monitoring of their condition through regular assessments, which may lead to personalized adjustments in care. Beyond physical improvements, engaging in the study can enhance overall well-being and function, potentially reducing work-related disability and improving quality of life. Finally, contributing to this research advances scientific understanding of effective LBP treatments, potentially benefiting broader patient populations in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective, three-arm, parallel-group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Guideline-Based Massage Therapy + Self-Massage Group (GMT+SM) | Experimental | Other: Guidline-basaed massage therapyGMT+SM - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists. Self-Massage Training: One in-person instructional session, plus take-home materials (videos and printed instructions). |
| Guideline-Based Massage Therapy (GMT) | Experimental | Other: Guidline-basaed massage therapyGMT - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists. |
| Control group (CG) | Active comparator | Other: Swedish massageParticipants receive Swedish massage |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult healthcare workers
- Aged 30-65 years with chronic nonspecific low back pain for ≥3 months
- No medical contraindications to massage therapy
- Body mass index (BMI) between 18.5 and 25 kg/m²
- Provided written informed consent
Key exclusion criteria (4 listed)
- Massage therapy within the past 3 months
- Contraindications to massage therapy
- Ongoing physical therapy
- Significant medical or psychiatric conditions
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 |
|---|---|---|
| Guidline-basaed massage therapyMassage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners | Other | Guideline-Based Massage Therapy (GMT), Guideline-Based Massage Therapy + Self-Massage Group (GMT+SM) |
| Swedish massageA classical form of therapeutic massage that uses a combination of long, flowing strokes, kneading, friction, tapping, and gentle stretching to promote relaxation, improve circulation, and reduce muscle tension. It is typically performed using oil or lotion to reduce friction on the skin. Techniques are applied with light to moderate pressure and are designed to enhance general well-being and support recovery from muscular discomfort or stress | Other | Control group (CG) |
Primary outcome
VAS scale
Time frame: From enrollment to the end of treatment at 2 weeks
Visual Analogue Scale (VAS) is a continuous scale consisting of a horizontal line, 100 mm long, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). VAS is frequently used to determine the effectiveness of treatment as an outcome measure. Most studies show that VAS is a valid and reliable scale.
ODI
Time frame: From enrollment to the end of treatment at 2 weeks
The ODI (Oswestry Disability Index) is a standardized questionnaire used to measure a patient's level of disability due to lower back pain. It assesses how back pain affects a person's ability to manage everyday life.
2 secondary outcomes
Thermography
Time frame: From enrollment to the end of treatment at 2 weeks
Doppler USG
Time frame: From enrollment to the end of treatment at 2 weeks
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 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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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
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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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.
Krzysztof K Principal Investigator principal investigator
Department of Massage and Physiotherapy, Wroclaw University of Health and Sport Sciences, Wroclaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidline-basaed massage therapy and Swedish massage in people with Low Back Pain, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 5 inclusion and 4 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 Feb 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 Poland. 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. 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 Marcin Piwecki (+48 665 569 523, p665569523@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS scale (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 2 primary outcomes in all. 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 Feb 2026.