Iliopsoas Counterstrain and Mechanical Chronic Low Back Pain

NCT06748859 | Completed DMC

• 1 other identifier: 2024/44-53
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mechanical Low Back Pain; Chronic Low Back Pain (CLBP)

Keywords

Mechanical chronic Low Back Pain; Myofascial Pain Syndromes; Strain-counterstrain; Psoas Muscles

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  2 weeks

Secondary Outcomes (18)

• thomas test

  Baseline

• thomas test

  30 minutes

• thomas test

  2 weeks

• Modified Schober's Test

  Baseline

• Modified Schober's Test

  30 minutes

Study Arms (2)

Strain-counterstrain technique

EXPERIMENTAL

Participants in this group will receive strain-counterstrain technique and exercise therapy within two weeks.

Other: Counterstrain technique

Exercise therapy

ACTIVE COMPARATOR

Participants in this group will receive exercise therapy within two weeks.

Other: Exercise therapy

Interventions

Counterstrain technique OTHER

In this group, participants will receive counterstrain technique on the Psoas major muscle and exercise training within two weeks.

Strain-counterstrain technique

Exercise therapy OTHER

participants who will assign to this group will receive exercise therapy within two weeks.

Exercise therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Able to understand and make communication with research team without any barrier;
• Having consent to participate the study.
• 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,

You may not qualify if:

• Willing to discontinue the study progress for any reason;
• Progressive deterioration during the study and intervention application.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Institute of Health Sciences

Kartal, Istanbul, 34865, Turkey (Türkiye)

Location

Related Publications (14)

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  PMID: 36169931 BACKGROUND

• Maharty DC, Hines SC, Brown RB. Chronic Low Back Pain in Adults: Evaluation and Management. Am Fam Physician. 2024 Mar;109(3):233-244.

  PMID: 38574213 BACKGROUND

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  PMID: 28476690 BACKGROUND

• Airaksinen 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.

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• Park 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.

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• Lakkadsha 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.

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• Siglan 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.

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• Ashrafi 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.

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• Wong 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.

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  PMID: 30930578 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Myofascial Pain Syndromes

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc. candidate of physiotherapy

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 27, 2024
• Study Start: December 25, 2024
• Primary Completion: February 23, 2025
• Study Completion: March 5, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

TU (1)