Mechanical Low Back PainNCT06748859
Iliopsoas Counterstrain and Mechanical Chronic Low Back Pain
A study testing Counterstrain technique and Exercise therapy in people with Mechanical Low Back Pain and Chronic Low Back Pain (CLBP), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of the Strain-Counterstrain (SCS) technique on alleviating sudden and mechanical chronic low back pain and resolving limited lumbar flexion and extension in individuals with mechanical chronic low back pain (MCLBP), focusing on tender points in the Iliopsoas muscle. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mechanical Low Back Pain, Chronic Low Back Pain (CLBP)
- What is being tested?
- Counterstrain technique and Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2024to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic mechanical low back pain (CMLBP) aged between 18-60 years old;
- Pain experience more than 12 weeks;
- Pain intensity ≥ 3 based on Numeric pain scale;
- Pain experience during lumbar flexion movement;
- Positive Thomas test;
- Having tenderness on Psoas major muscle 4 times more than palpation on ipsilateral quadratus lumborum muscle;
Show all 12Show fewer
- Able to understand and make communication with research team without any barrier;
- Having consent to participate the study.
- Non-inclusion criteria:
- Pregnancy;
- Not indicated for lumbar surgery based on diagnosis of a physical medicine and rehabilitation specialist,
- Any type of fracture or history of trauma which makes manual therapy contraindicated for the patient,
Who cannot join
- Willing to discontinue the study progress for any reason;
- Progressive deterioration during the study and intervention application.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Institute of Health Sciences
Kartal, Istanbul, 34865
About this study
Official title: The Effect of Iliopsoas Strain-counterstrain Technique on Mechanical Chronic Low Back Pain and Lumbar Flexion Restriction
The aim of this study is to determine the effects of the Strain-Counterstrain (SCS) technique on alleviating sudden and mechanical chronic low back pain and resolving limited lumbar flexion and extension in individuals with mechanical chronic low back pain (MCLBP), focusing on tender points in the Iliopsoas muscle. Our study is a randomized controlled trial. Based on sample size calculation, 32 voluntary patients with chronic mechanical low back pain will be recruited to the study. They will be then randomized into two groups using the Block Balanced Randomization method.
In the control group, consisting of 16 participants, 4 general exercises aimed at relieving back pain will be performed under the physical therapist's supervision. In the treatment group, also comprising 16 participants, after performing the exercises applied to the control group, the SCS technique will be applied to the tender points in the iliopsoas muscle: 90 seconds in a position of comfort, with 30-second intervals, 3 times on the more tender side and 2 times on the less tender side.
The assessment of the cases will use the visual analog scale (VAS) for pain intensity at rest and during lumbar flexion movement as primary outcome measurements TiltMeter© Application for joint range of motion (ROM), Modified Schober's Test (MST) for spinal mobility, Thomas test for iliopsoas muscle length, the Oswestry Disability Index (ODI) for stability, and 36-Item Short Form Survey (SF-36) for health-related quality of life. Assessments will be conducted before treatment, at the end of the 1st session, and at the end of the treatment (after six sessions). Significant results may reduce the burden on the healthcare system with the ease of application and low-cost advantage of the SCS technique, making treatment processes more efficient.
Read the detailed description
Low back pain is one of the leading causes of disability and has been shown to occur more frequently than other health problems. When low back pain becomes chronic, the pain may often be less intense. Chronic low back pain is defined as pain that persists for more than 12 weeks. Many professionals and individuals working in demanding jobs often experience Chronic Non-Specific Low Back Pain, which results in reduced work capacity and significant impairment in daily activities. Additionally, many patients report increased pain while sitting or transitioning from a seated to a standing position.
Despite the rising number of patients presenting to hospitals with low back pain, the exact underlying cause is often not well understood. Recent studies suggest that most cases are due to mechanical causes, potentially resulting from improper biomechanical alignment.
The spinal curves, known as lordosis and kyphosis, play a critical role in energy expenditure and mobility from a biomechanical perspective. Improper adaptations and tensions between muscles can lead to either a loss or increase in lumbar lordosis, which can alter biomechanical structure and affect muscle function and range of motion. The psoas major muscle, which attaches to the L1-L5 vertebrae, can also influence lumbar lordosis if it becomes shortened.
Low back pain is typically nonspecific or mechanical. Mechanical chronic low back pain (CLBP) arises from the spine, intervertebral discs, or surrounding soft tissues due to excessive strain or injury. The iliopsoas muscles, deep muscles rarely stretched during daily activities, can become tense and contribute to this pain. As one of the strongest hip flexors, the iliopsoas plays a significant role in pelvic movement and stabilization. Tightness in the iliopsoas is often closely linked to low back pain. A shortened iliopsoas group may result in hyperlordosis, anterior pelvic tilt, and increased pressure on the spinal muscles. If the iliopsoas muscles are excessively tight, they can pull and twist the vertebrae, leading to disc compression and dysfunction, which may manifest as low back pain and discomfort around the sacroiliac joint. Research has found that individuals who work at desks often have shortened iliopsoas muscles, which can predispose them to future low back pain.
Individuals who sit for extended periods, such as sedentary workers and students, are at increased risk of musculoskeletal problems and muscle shortening. Research has shown that sitting for more than eight consecutive hours can lead to low back pain. The iliopsoas muscle, due to its unique connection between the lumbar spine and hip joint, is an important hip flexor affected by prolonged sitting. Biomechanical and electromyography studies suggest that control of the spinal curve is primarily provided by the psoas major muscle. When other muscles become less active, the psoas major becomes more engaged, helping to maintain an upright spine; however, a shortened psoas can lead to pelvic tilt and back pain.
Given the above reasons, many studies have been conducted to address iliopsoas muscle tightness. Research comparing techniques such as Proprioceptive Neuromuscular Facilitation (PNF) and Muscle Energy Technique (MET) for stretching the iliopsoas found that PNF was more effective, emphasizing the benefits of active mobilization and autonomic inhibition. However, muscle tightness can also originate from tender points, which, when addressed, can enhance proprioceptive activity and reduce hypersensitivity once the joint returns to its normal position. Despite the biomechanical importance of the iliopsoas muscle, research specifically focusing on tender points in this muscle remains limited.
Strain-Counterstrain is an osteopathic manipulation technique and the fourth most commonly used soft tissue method after High Velocity Low Amplitude (HVLA) and Muscle Energy Techniques (MET). This technique involves passive positional mobilization designed to alleviate musculoskeletal pain. Strain-Counterstrain helps correct neuromuscular imbalances caused by prolonged muscle stimulation. It is based on the proprioceptive theory, which suggests that this technique can rectify abnormal neuromuscular activity, often caused by sympathetic nervous system responses or inflammatory reactions. Studies have shown that the Strain-Counterstrain technique effectively restores range of motion and reduces pain in the lumbar region. Additionally, it is a low-cost, non-invasive treatment method. For example, a study demonstrated that both SCS and MET were effective in reducing pain and improving functional capacity in patients with chronic low back pain. Other research has reported positive effects on lumbar range of motion, pain, and quality of life when SCS was combined with techniques such as MET or McKenzie.
Most studies have focused on the quadratus lumborum muscle or general SCS techniques, and although the iliopsoas muscle is critically important, it has been less frequently studied in conjunction with SCS. Our study aims to clearly demonstrate the immediate and long-term effects of the iliopsoas-specific SCS technique on lumbar range of motion and pain, ultimately reducing the burden on healthcare systems in terms of labor and cost.
Hypotheses:
Null Hypothesis (H0): The Strain-Counterstrain technique has no positive effect on pain and restricted lumbar flexion in patients with chronic low back pain and limited lumbar flexion.
Alternative Hypothesis (H1): The Strain-Counterstrain technique has a positive effect on pain and restricted lumbar flexion in patients with chronic low back pain and limited lumbar flexion.
- Being tested
- Counterstrain technique, Exercise therapy
- Keywords
- Mechanical chronic Low Back Pain, Myofascial Pain Syndromes, Strain-counterstrain, Psoas Muscles
- Medical subject headings
- Low Back Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counterstrain techniqueOther
In this group, participants will receive counterstrain technique on the Psoas major muscle and exercise training within two weeks.
Exercise therapyOther
participants who will assign to this group will receive exercise therapy within two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Strain-counterstrain technique | Experimental | Participants in this group will receive strain-counterstrain technique and exercise therapy within two weeks. Receives: Other: Counterstrain technique |
| Exercise therapy | Active comparator | Participants in this group will receive exercise therapy within two weeks. Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale at rest
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
Measured: Baseline
visual analog scale at rest
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
Measured: 30 minutes
visual analog scale at rest
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
Measured: 2 weeks
visual analog scale during lumbar flexion
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
Measured: Baseline
visual analog scale during lumbar flexion
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
Measured: 30 minutes
visual analog scale during lumbar flexion
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
Measured: 2 weeks
Secondary outcomes (18)
thomas test
The Thomas test is a method used to evaluate the shortening of the Iliopsoas muscle. There is no shortening if the tested leg is completely parallel to the bed. However, if the leg remains elevated from the bed, the angle should be recorded with a goniometer.
Measured: Baseline
thomas test
The Thomas test is a method used to evaluate the shortening of the Iliopsoas muscle. There is no shortening if the tested leg is completely parallel to the bed. However, if the leg remains elevated from the bed, the angle should be recorded with a goniometer.
Measured: 30 minutes
thomas test
The Thomas test is a method used to evaluate the shortening of the Iliopsoas muscle. There is no shortening if the tested leg is completely parallel to the bed. However, if the leg remains elevated from the bed, the angle should be recorded with a goniometer.
Measured: 2 weeks
Modified Schober's Test
It is a commonly used method for assessing lumbar mobility. The patient stands with their feet shoulder-width apart, and a mark is placed between two posterior superior iliac spines (PSIS), adding 15 cm to it. The patient is then instructed to bend forward without bending their knees. The new distance between the two points is measured again, 15 cm is subtracted, and the result is recorded.
Measured: Baseline
Modified Schober's Test
It is a commonly used method for assessing lumbar mobility. The patient stands with their feet shoulder-width apart, and a mark is placed between two PSIS, adding 15 cm to it. The patient is then instructed to bend forward without bending their knees. The new distance between the two points is measured again, 15 cm is subtracted, and the result is recorded.
Measured: 30 minutes
Modified Schober's Test
It is a commonly used method for assessing lumbar mobility. The patient stands with their feet shoulder-width apart, and a mark is placed between two PSIS, adding 15 cm to it. The patient is then instructed to bend forward without bending their knees. The new distance between the two points is measured again, 15 cm is subtracted, and the result is recorded.
Measured: 2 weeks
lumbar flexion range of motion
TiltMeter© app with an iPhone© could efficiently measure lumbar spine flexion ROM. The iPhone© is placed at T12-L1 and then at S1-S2 during maximum flexion of the lumbar spine. Total ROM is calculated by subtracting the S1-S2 measurement from T12-L1.
Measured: Baseline
lumbar flexion range of motion
TiltMeter© app with an iPhone© could efficiently measure lumbar spine flexion ROM. The iPhone© is placed at T12-L1 and then at S1-S2 during maximum flexion of the lumbar spine. Total ROM is calculated by subtracting the S1-S2 measurement from T12-L1.
Measured: 30 minutes
lumbar flexion range of motion
TiltMeter© app with an iPhone© could efficiently measure lumbar spine flexion ROM. The iPhone© is placed at T12-L1 and then at S1-S2 during maximum flexion of the lumbar spine. Total ROM is calculated by subtracting the S1-S2 measurement from T12-L1.
Measured: 2 weeks
lumbar extension range of motion
TiltMeter© app with an iPhone© could efficiently measure lumbar spine extension ROM. The iPhone© is placed at T12-L1 and then at S1-S2 during maximum extension of the lumbar spine. Total ROM is calculated by subtracting the S1-S2 measurement from T12-L1.
Measured: Baseline
lumbar extension range of motion
TiltMeter© app with an iPhone© could efficiently measure lumbar spine extension ROM. The iPhone© is placed at T12-L1 and then at S1-S2 during maximum extension of the lumbar spine. Total ROM is calculated by subtracting the S1-S2 measurement from T12-L1.
Measured: 30 minutes
lumbar extension range of motion
TiltMeter© app with an iPhone© could efficiently measure lumbar spine extension ROM. The iPhone© is placed at T12-L1 and then at S1-S2 during maximum extension of the lumbar spine. Total ROM is calculated by subtracting the S1-S2 measurement from T12-L1.
Measured: 2 weeks
Oswestry Low Back Pain Scale
The Oswestry Disability Index assesses various aspects of daily life functioning through 10 different categories, such as pain intensity, personal care, mobility, and social activities. Each category consists of 6 questions, with each question scored on a scale of 0 to 5. The total score ranges from 0 to 50, which can then be converted to a scale of 0 to 100.Higher values represent a worse outcome.
Measured: Baseline
Oswestry Low Back Pain Scale
The Oswestry Disability Index assesses various aspects of daily life functioning through 10 different categories, such as pain intensity, personal care, mobility, and social activities. Each category consists of 6 questions, with each question scored on a scale of 0 to 5. The total score ranges from 0 to 50, which can then be converted to a scale of 0 to 100.Higher values represent a worse outcome.
Measured: 30 minutes
Oswestry Low Back Pain Scale
The Oswestry Disability Index assesses various aspects of daily life functioning through 10 different categories, such as pain intensity, personal care, mobility, and social activities. Each category consists of 6 questions, with each question scored on a scale of 0 to 5. The total score ranges from 0 to 50, which can then be converted to a scale of 0 to 100.Higher values represent a worse outcome.
Measured: 2 weeks
SF-36
The scale evaluates quality of life across eight different subcategories: physical functioning, physical role difficulty, emotional role difficulty, energy, mental health, social functioning, pain, and general health perception. Each subcategory is scored between 0 and 100, Higher values represent a worse outcome.
Measured: Baseline
SF-36
The scale evaluates quality of life across eight different subcategories: physical functioning, physical role difficulty, emotional role difficulty, energy, mental health, social functioning, pain, and general health perception. Each subcategory is scored between 0 and 100, Higher values represent a worse outcome.
Measured: 30 minutes
SF-36
The scale evaluates quality of life across eight different subcategories: physical functioning, physical role difficulty, emotional role difficulty, energy, mental health, social functioning, pain, and general health perception. Each subcategory is scored between 0 and 100, Higher values represent a worse outcome.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start25 Dec 2024
- Primary completion23 Feb 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Hassanzadeh, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748859
- Sponsor's protocol ID
- 2024/44-53
- Status last verified
- Mar 2025
- First submitted
- 13 Dec 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided yet, but at this moment, we decided to share brief data with future researchers after requesting and submitting ethical committee permission.
Publications
Fernandes WVB, Blanco CR, Politti F, de Cordoba Lanza F, Lucareli PRG, Correa JCF. The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial. Trials. 2018 Mar 2;19(1):151. doi: 10.1186/s13063-018-2532-8.
PubMed 29499728Santos GK, Goncalves de Oliveira R, Campos de Oliveira L, Ferreira C de Oliveira C, Andraus RA, Ngomo S, Fusco A, Cortis C, DA Silva RA. Effectiveness of muscle energy technique in patients with nonspecific low back pain: a systematic review with meta-analysis. Eur J Phys Rehabil Med. 2022 Dec;58(6):827-837. doi: 10.23736/S1973-9087.22.07424-X. Epub 2022 Sep 28.
PubMed 36169931Maharty DC, Hines SC, Brown RB. Chronic Low Back Pain in Adults: Evaluation and Management. Am Fam Physician. 2024 Mar;109(3):233-244.
PubMed 38574213Chun SW, Lim CY, Kim K, Hwang J, Chung SG. The relationships between low back pain and lumbar lordosis: a systematic review and meta-analysis. Spine J. 2017 Aug;17(8):1180-1191. doi: 10.1016/j.spinee.2017.04.034. Epub 2017 May 2.
PubMed 28476690Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
PubMed 16550448Park MW, Park SJ, Chung SG. Relationships Between Skeletal Muscle Mass, Lumbar Lordosis, and Chronic Low Back Pain in the Elderly. Neurospine. 2023 Sep;20(3):959-968. doi: 10.14245/ns.2346494.247. Epub 2023 Sep 30.
PubMed 37798990Jorgensson A. The iliopsoas muscle and the lumbar spine. Aust J Physiother. 1993;39(2):125-32. doi: 10.1016/S0004-9514(14)60477-3.
PubMed 25026138Lakkadsha TM, Qureshi MI, Kovela RK, Saifee SS, Lalwani SS. Efficacy of Single Stretching Session of Iliopsoas Using Proprioceptive Neuromuscular Facilitation Versus Muscle Energy Technique on Low Back Pain in Patients With Lumbar Hyper-Lordosis. Cureus. 2022 Aug 12;14(8):e27916. doi: 10.7759/cureus.27916. eCollection 2022 Aug.
PubMed 36110466Lifshitz L, Bar Sela S, Gal N, Martin R, Fleitman Klar M. Iliopsoas the Hidden Muscle: Anatomy, Diagnosis, and Treatment. Curr Sports Med Rep. 2020 Jun;19(6):235-243. doi: 10.1249/JSR.0000000000000723.
PubMed 32516195Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
PubMed 36775506Tanigawa MC. Comparison of the hold-relax procedure and passive mobilization on increasing muscle length. Phys Ther. 1972 Jul;52(7):725-35. doi: 10.1093/ptj/52.7.725. No abstract available.
PubMed 5034102Ashrafi A, Arab AM, Abdi S, Nourbakhsh MR. The association between myofascial trigger points and the incidence of chronic functional constipation. J Bodyw Mov Ther. 2021 Apr;26:201-206. doi: 10.1016/j.jbmt.2020.12.004. Epub 2020 Dec 3.
PubMed 33992245Wong CK. Strain counterstrain: current concepts and clinical evidence. Man Ther. 2012 Feb;17(1):2-8. doi: 10.1016/j.math.2011.10.001. Epub 2011 Oct 24.
PubMed 22030379Patel VD, Eapen C, Ceepee Z, Kamath R. Effect of muscle energy technique with and without strain-counterstrain technique in acute low back pain - A randomized clinical trial. Hong Kong Physiother J. 2018 Jun;38(1):41-51. doi: 10.1142/S1013702518500051. Epub 2018 Apr 4.
PubMed 30930578
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Iliopsoas Strain-counterstrain Technique on Mechanical Chronic Low Back Pain and Lumbar Flexion Restriction
- ClinicalTrials.gov ID
- NCT06748859
- Acronym / sponsor ID
- 2024/44-53
- Keywords
- Mechanical chronic Low Back Pain, Myofascial Pain Syndromes, Strain-counterstrain, Psoas Muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 27 Dec 2024 (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 aim of this study is to determine the effects of the Strain-Counterstrain (SCS) technique on alleviating sudden and mechanical chronic low back pain and resolving limited lumbar flexion and extension in individuals with mechanical chronic low back pain (MCLBP), focusing on tender points in the Iliopsoas muscle. Our study is a randomized controlled trial. Based on sample size calculation, 32 voluntary patients with chronic mechanical low back pain will be recruited to the study. They will be then randomized into two groups using the Block Balanced Randomization method.
In the control group, consisting of 16 participants, 4 general exercises aimed at relieving back pain will be performed under the physical therapist's supervision. In the treatment group, also comprising 16 participants, after performing the exercises applied to the control group, the SCS technique will be applied to the tender points in the iliopsoas muscle: 90 seconds in a position of comfort, with 30-second intervals, 3 times on the more tender side and 2 times on the less tender side.
The assessment of the cases will use the visual analog scale (VAS) for pain intensity at rest and during lumbar flexion movement as primary outcome measurements TiltMeter© Application for joint range of motion (ROM), Modified Schober's Test (MST) for spinal mobility, Thomas test for iliopsoas muscle length, the Oswestry Disability Index (ODI) for stability, and 36-Item Short Form Survey (SF-36) for health-related quality of life. Assessments will be conducted before treatment, at the end of the 1st session, and at the end of the treatment (after six sessions). Significant results may reduce the burden on the healthcare system with the ease of application and low-cost advantage of the SCS technique, making treatment processes more efficient.
Detailed description
Low back pain is one of the leading causes of disability and has been shown to occur more frequently than other health problems. When low back pain becomes chronic, the pain may often be less intense. Chronic low back pain is defined as pain that persists for more than 12 weeks. Many professionals and individuals working in demanding jobs often experience Chronic Non-Specific Low Back Pain, which results in reduced work capacity and significant impairment in daily activities. Additionally, many patients report increased pain while sitting or transitioning from a seated to a standing position.
Despite the rising number of patients presenting to hospitals with low back pain, the exact underlying cause is often not well understood. Recent studies suggest that most cases are due to mechanical causes, potentially resulting from improper biomechanical alignment.
The spinal curves, known as lordosis and kyphosis, play a critical role in energy expenditure and mobility from a biomechanical perspective. Improper adaptations and tensions between muscles can lead to either a loss or increase in lumbar lordosis, which can alter biomechanical structure and affect muscle function and range of motion. The psoas major muscle, which attaches to the L1-L5 vertebrae, can also influence lumbar lordosis if it becomes shortened.
Low back pain is typically nonspecific or mechanical. Mechanical chronic low back pain (CLBP) arises from the spine, intervertebral discs, or surrounding soft tissues due to excessive strain or injury. The iliopsoas muscles, deep muscles rarely stretched during daily activities, can become tense and contribute to this pain. As one of the strongest hip flexors, the iliopsoas plays a significant role in pelvic movement and stabilization. Tightness in the iliopsoas is often closely linked to low back pain. A shortened iliopsoas group may result in hyperlordosis, anterior pelvic tilt, and increased pressure on the spinal muscles. If the iliopsoas muscles are excessively tight, they can pull and twist the vertebrae, leading to disc compression and dysfunction, which may manifest as low back pain and discomfort around the sacroiliac joint. Research has found that individuals who work at desks often have shortened iliopsoas muscles, which can predispose them to future low back pain.
Individuals who sit for extended periods, such as sedentary workers and students, are at increased risk of musculoskeletal problems and muscle shortening. Research has shown that sitting for more than eight consecutive hours can lead to low back pain. The iliopsoas muscle, due to its unique connection between the lumbar spine and hip joint, is an important hip flexor affected by prolonged sitting. Biomechanical and electromyography studies suggest that control of the spinal curve is primarily provided by the psoas major muscle. When other muscles become less active, the psoas major becomes more engaged, helping to maintain an upright spine; however, a shortened psoas can lead to pelvic tilt and back pain.
Given the above reasons, many studies have been conducted to address iliopsoas muscle tightness. Research comparing techniques such as Proprioceptive Neuromuscular Facilitation (PNF) and Muscle Energy Technique (MET) for stretching the iliopsoas found that PNF was more effective, emphasizing the benefits of active mobilization and autonomic inhibition. However, muscle tightness can also originate from tender points, which, when addressed, can enhance proprioceptive activity and reduce hypersensitivity once the joint returns to its normal position. Despite the biomechanical importance of the iliopsoas muscle, research specifically focusing on tender points in this muscle remains limited.
Strain-Counterstrain is an osteopathic manipulation technique and the fourth most commonly used soft tissue method after High Velocity Low Amplitude (HVLA) and Muscle Energy Techniques (MET). This technique involves passive positional mobilization designed to alleviate musculoskeletal pain. Strain-Counterstrain helps correct neuromuscular imbalances caused by prolonged muscle stimulation. It is based on the proprioceptive theory, which suggests that this technique can rectify abnormal neuromuscular activity, often caused by sympathetic nervous system responses or inflammatory reactions. Studies have shown that the Strain-Counterstrain technique effectively restores range of motion and reduces pain in the lumbar region. Additionally, it is a low-cost, non-invasive treatment method. For example, a study demonstrated that both SCS and MET were effective in reducing pain and improving functional capacity in patients with chronic low back pain. Other research has reported positive effects on lumbar range of motion, pain, and quality of life when SCS was combined with techniques such as MET or McKenzie.
Most studies have focused on the quadratus lumborum muscle or general SCS techniques, and although the iliopsoas muscle is critically important, it has been less frequently studied in conjunction with SCS. Our study aims to clearly demonstrate the immediate and long-term effects of the iliopsoas-specific SCS technique on lumbar range of motion and pain, ultimately reducing the burden on healthcare systems in terms of labor and cost.
Hypotheses:
Null Hypothesis (H0): The Strain-Counterstrain technique has no positive effect on pain and restricted lumbar flexion in patients with chronic low back pain and limited lumbar flexion.
Alternative Hypothesis (H1): The Strain-Counterstrain technique has a positive effect on pain and restricted lumbar flexion in patients with chronic low back pain and limited lumbar flexion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strain-counterstrain technique | Experimental | Other: Counterstrain techniqueParticipants in this group will receive strain-counterstrain technique and exercise therapy within two weeks. |
| Exercise therapy | Active comparator | Other: Exercise therapyParticipants in this group will receive exercise therapy within two weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients with chronic mechanical low back pain (CMLBP) aged between 18-60 years old;
- Pain experience more than 12 weeks;
- Pain intensity ≥ 3 based on Numeric pain scale;
- Pain experience during lumbar flexion movement;
- Positive Thomas test;
Key exclusion criteria (2 listed)
- Willing to discontinue the study progress for any reason;
- Progressive deterioration during the study and intervention application.
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 |
|---|---|---|
| Counterstrain techniqueIn this group, participants will receive counterstrain technique on the Psoas major muscle and exercise training within two weeks. | Other | Strain-counterstrain technique |
| Exercise therapyparticipants who will assign to this group will receive exercise therapy within two weeks. | Other | Exercise therapy |
Primary outcome
visual analog scale at rest
Time frame: Baseline
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
visual analog scale at rest
Time frame: 30 minutes
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
visual analog scale at rest
Time frame: 2 weeks
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
visual analog scale during lumbar flexion
Time frame: Baseline
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
visual analog scale during lumbar flexion
Time frame: 30 minutes
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
visual analog scale during lumbar flexion
Time frame: 2 weeks
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest, representing the most severe pain.
18 secondary outcomes
thomas test
Time frame: Baseline
thomas test
Time frame: 30 minutes
thomas test
Time frame: 2 weeks
Modified Schober's Test
Time frame: Baseline
Modified Schober's Test
Time frame: 30 minutes
Modified Schober's Test
Time frame: 2 weeks
lumbar flexion range of motion
Time frame: Baseline
lumbar flexion range of motion
Time frame: 30 minutes
lumbar flexion range of motion
Time frame: 2 weeks
lumbar extension range of motion
Time frame: Baseline
lumbar extension range of motion
Time frame: 30 minutes
lumbar extension range of motion
Time frame: 2 weeks
Oswestry Low Back Pain Scale
Time frame: Baseline
Oswestry Low Back Pain Scale
Time frame: 30 minutes
Oswestry Low Back Pain Scale
Time frame: 2 weeks
SF-36
Time frame: Baseline
SF-36
Time frame: 30 minutes
SF-36
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Results publication: PubMed 29499728Fernandes WVB, Blanco CR, Politti F, de Cordoba Lanza F, Lucareli PRG, Correa JCF. The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial. Trials. 2018 Mar 2;19(1):151. doi: 10.1186/s13063-018-2532-8.
- Results publication: PubMed 36169931Santos GK, Goncalves de Oliveira R, Campos de Oliveira L, Ferreira C de Oliveira C, Andraus RA, Ngomo S, Fusco A, Cortis C, DA Silva RA. Effectiveness of muscle energy technique in patients with nonspecific low back pain: a systematic review with meta-analysis. Eur J Phys Rehabil Med. 2022 Dec;58(6):827-837. doi: 10.23736/S1973-9087.22.07424-X. Epub 2022 Sep 28.
- Results publication: PubMed 38574213Maharty DC, Hines SC, Brown RB. Chronic Low Back Pain in Adults: Evaluation and Management. Am Fam Physician. 2024 Mar;109(3):233-244.
- Results publication: PubMed 28476690Chun SW, Lim CY, Kim K, Hwang J, Chung SG. The relationships between low back pain and lumbar lordosis: a systematic review and meta-analysis. Spine J. 2017 Aug;17(8):1180-1191. doi: 10.1016/j.spinee.2017.04.034. Epub 2017 May 2.
- Results publication: PubMed 16550448Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
- Results publication: PubMed 37798990Park MW, Park SJ, Chung SG. Relationships Between Skeletal Muscle Mass, Lumbar Lordosis, and Chronic Low Back Pain in the Elderly. Neurospine. 2023 Sep;20(3):959-968. doi: 10.14245/ns.2346494.247. Epub 2023 Sep 30.
- Results publication: PubMed 25026138Jorgensson A. The iliopsoas muscle and the lumbar spine. Aust J Physiother. 1993;39(2):125-32. doi: 10.1016/S0004-9514(14)60477-3.
- Results publication: PubMed 36110466Lakkadsha TM, Qureshi MI, Kovela RK, Saifee SS, Lalwani SS. Efficacy of Single Stretching Session of Iliopsoas Using Proprioceptive Neuromuscular Facilitation Versus Muscle Energy Technique on Low Back Pain in Patients With Lumbar Hyper-Lordosis. Cureus. 2022 Aug 12;14(8):e27916. doi: 10.7759/cureus.27916. eCollection 2022 Aug.
- Results publication: PubMed 32516195Lifshitz L, Bar Sela S, Gal N, Martin R, Fleitman Klar M. Iliopsoas the Hidden Muscle: Anatomy, Diagnosis, and Treatment. Curr Sports Med Rep. 2020 Jun;19(6):235-243. doi: 10.1249/JSR.0000000000000723.
- Results publication: PubMed 36775506Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.
- Results publication: PubMed 5034102Tanigawa MC. Comparison of the hold-relax procedure and passive mobilization on increasing muscle length. Phys Ther. 1972 Jul;52(7):725-35. doi: 10.1093/ptj/52.7.725. No abstract available.
- Results publication: PubMed 33992245Ashrafi A, Arab AM, Abdi S, Nourbakhsh MR. The association between myofascial trigger points and the incidence of chronic functional constipation. J Bodyw Mov Ther. 2021 Apr;26:201-206. doi: 10.1016/j.jbmt.2020.12.004. Epub 2020 Dec 3.
- Individual participant dataSharing planned: Undecided. We have not decided yet, but at this moment, we decided to share brief data with future researchers after requesting and submitting ethical committee permission.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counterstrain technique and Exercise therapy in people with Mechanical Low Back Pain and Chronic Low Back Pain (CLBP), run by Marmara University at 1 site in Turkey (Türkiye).
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 12 inclusion and 2 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale at rest (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748859, which also lists 14 linked publications.
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 6 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.