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IRCT20260206068774N1 IRCT 2026-05-17 Tehran University of Medical Sciences Effect of Iliopsoas Muscle Treatment Combined with the McKenzie Method in Chronic Low Back Pain Comparison of the Effects of Iliopsoas Strain-Counterstrain Technique and McKenzie Exercise Therapy on Directional Preference in Patients with Chronic Non-Specific Low Back Pain 2026-05-19 anticipated 100 Recruiting https://irct.ir/trial/89988 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a parallel-group, single-blind randomized clinical trial. Participants will be randomly assigned (1:1 ratio) using blocked randomization with blocks of 4 to either the Iliopsoas Strain-Counterstrain group or the McKenzie Method group. Both groups will receive 3 treatment sessions (approximately 30 minutes each) over a maximum of one week. Pre- and post-intervention assessments will be performed by a blinded evaluator. The primary outcome is Directional Preference status (categorized as Stable, Changed, or Newly Developed). Data analysis will be conducted based on the Intention-to-Treat principle. This is a non-pharmacological interventional study, Randomization description: This is a parallel-group, single-blind randomized clinical trial. Eligible participants will be randomly allocated to one of the two study groups (Strain-Counterstrain or McKenzie) in a 1:1 ratio using blocked randomization with randomly permuted blocks of size 4. The randomization sequence will be generated by an independent person not involved in the study using the website Randomization.com. To ensure allocation concealment, the randomization codes will be placed in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened only after the participant has been recruited and has completed the baseline assessment, Blinding description: Due to the nature of the interventions (manual therapy technique versus exercise therapy), it is not possible to blind the therapists or participants. However, this study is designed as single-blind. The outcome assessor (evaluator) who performs the pre- and post-intervention assessments (including MDT evaluation, Directional Preference determination, range of motion, and pain assessment) will be blinded to group allocation. In addition, the statistician who performs the data analysis will also be blinded to group assignment. All data will be coded (e.g., Group A and Group B) before being provided to the statistician. N/A Chronic non-specific low back pain. Intervention 1: Intervention group: Strain Counterstrain technique applied to tender points of the iliopsoas muscle. The therapist identifies tender points and places the limb in a position of comfort (at least 70% pain reduction at the tender point), which is held for 90 seconds. A maximum of 1 to 2 tender points per side are treated. This intervention is performed in 3 treatment sessions (approximately 30 minutes each) over a maximum of one week. Intervention 2: Control group: Mechanical Diagnosis and Therapy (McKenzie Method). Participants are first assessed using the standard McKenzie lumbar assessment form to determine directional preference. They then perform repeated movements in the identified directional preference (flexion, extension, or lateral) with loading progression. This intervention is also delivered in 3 treatment sessions (approximately 30 minutes each) over a maximum of one week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decision regarding sharing of individual participant data has not been made yet
public Amirhossein Bahari
No.179, Somayeh dormitory, Somayeh street, Tehran
Tehran Iran (Islamic Republic of) 1581749811 +98 13 3358 3094 amir.bahari8081@gmail.com Tehran University of Medical Sciences scientific Amirhossein Bahari
No.179, Somayeh dormitory, Somayeh street, Tehran
Tehran Iran (Islamic Republic of) 1581749811 +98 13 3358 3094 amir.bahari8081@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with non-specific chronic low back pain (NSCLBP) with duration of more than 3 months (≥12 weeks). Age between 18 and 70 years. Presence of mechanical low back dysfunction based on clinical assessment. Presence of at least one tender point in the iliopsoas muscle (unilateral or bilateral). Absence of relevant lateral shift. 18 years 70 years Both Loss or absence of Directional Preference (DP) in the initial assessment Skin infection in the groin area. Acute iliopsoas injury (hematoma or acute strain). History of inguinal hernia repair with mesh. Pelvic visceral disorders. History of pelvic surgery. Pregnancy at the time of the study. Fracture, tumor, inflammatory or infectious diseases of the spine. Evidence of nerve root involvement (radiculopathy) such as muscle weakness, reflex changes, or sensory deficits in the lower extremities. History of lumbar spine surgery. Lumbar spinal fusion. Bowel or bladder incontinence, or saddle anesthesia (symptoms of Cauda Equina Syndrome). Cognitive impairment or inability to communicate effectively. Unwillingness to continue participation in the study. Inability to read and write. M54.5 Low back pain Treatment - Other Treatment - Other Intervention group: Strain Counterstrain technique applied to tender points of the iliopsoas muscle. The therapist identifies tender points and places the limb in a position of comfort (at least 70% pain reduction at the tender point), which is held for 90 seconds. A maximum of 1 to 2 tender points per side are treated. This intervention is performed in 3 treatment sessions (approximately 30 minutes each) over a maximum of one week. Control group: Mechanical Diagnosis and Therapy (McKenzie Method). Participants are first assessed using the standard McKenzie lumbar assessment form to determine directional preference. They then perform repeated movements in the identified directional preference (flexion, extension, or lateral) with loading progression. This intervention is also delivered in 3 treatment sessions (approximately 30 minutes each) over a maximum of one week. Directional Preference status, Directional Preference status is categorized into three groups: stable (direction remains the same before and after treatment), changed (direction changes after treatment), or newly developed (directional preference appears after treatment). Timepoint: before the intervention (baseline) and after completion of three treatment sessions (post-intervention). Method of measurement: Assessed using the standards McKenzie Lumbar Assessment Form by a certified McKenzie therapist. Directional preference is determined based on the patient's response to repeated movements in different directions. Intensity and quality of pain. Timepoint: Before intervention and after three treatment sessions. Method of measurement: Short-Form McGill Pain Questionnaire (SF-MPQ). Flexion and extension range of motion of the lumbar spine. Timepoint: Before intervention and after three treatment sessions. Method of measurement: Using TiltMeter smartphone application installed on an iPhone. Tehran University of Medical Sciences Approved 2025-12-24 Ethics committee of Tehran University of Medical Sciences Rooms 604-605, 6th Floor, Central Office Building, Tehran University of Medical Sciences, Keshavarz Boulevard, at the corner of Ghods Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)