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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

Protocol summary

Study aim
The main objective of this study is to compare the effect of iliopsoas Strain Counterstrain technique with McKenzie exercise therapy on directional preference in patients with chronic non specific low back pain.
Design
Randomized controlled clinical trial, parallel groups, single-blind (assessor-blinded), on 100 patients with chronic non-specific low back pain; randomization in a 1:1 ratio using a randomization website.
Settings and conduct
This study will be conducted at the physiotherapy clinic of School of Rehabilitation Sciences, Tehran University of Medical Sciences and Rofideh Rehabilitation Hospital. Eligible patients will be randomly allocated to two treatment groups after baseline assessment and informed consent. Both groups will receive 3 treatment sessions (approximately 30 minutes each) within a maximum of one week. Pre- and post-intervention assessments will be performed by a blinded evaluator.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18-70 years, non-specific low back pain for more than three months, presence of iliopsoas tender point, and mechanical low back dysfunction. Exclusion Criteria: Red flags (fracture, tumor, infection), history of lumbar or pelvic surgery, pregnancy, radiculopathy, acute iliopsoas injury, and unwillingness to participate.
Intervention groups
Strain Counterstrain group: Participants receive the Strain Counterstrain technique on iliopsoas tender points (position of comfort held for 90 seconds per point). McKenzie group: Participants are assessed using the McKenzie method and perform repeated movements in their identified directional preference. Both groups will receive 3 treatment sessions (approximately 30 minutes each) over a maximum of one week.
Main outcome variables
Directional preference status (stable, changed, or newly developed) measured before and after intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260206068774N1
Registration date: 2026-05-17, 1405/02/27
Registration timing: prospective

Last update: 2026-05-17, 1405/02/27
Update count: 0
Registration date
2026-05-17, 1405/02/27
Registrant information
Name
Amirhossein Bahari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3358 3094
Email address
amir.bahari8081@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-19, 1405/02/29
Expected recruitment end date
2026-07-21, 1405/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Iliopsoas Muscle Treatment Combined with the McKenzie Method in Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Rooms 604-605, 6th Floor, Central Office Building, Tehran University of Medical Sciences, Keshavarz Boulevard, at the corner of Ghods Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
141765383761
Approval date
2025-12-24, 1404/10/03
Ethics committee reference number
IR.TUMS.FNM.REC.1404.208

Health conditions studied

1

Description of health condition studied
Chronic non-specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
Intensity and quality of pain
Timepoint
Before intervention and after three treatment sessions
Method of measurement
Short-Form McGill Pain Questionnaire (SF-MPQ)

2

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rofeideh Rehabilitation hospital
Full name of responsible person
Amirhossein Kahlaee
Street address
Rofideh Rehabilitation Hospital, Shahid Nemati Alley, South Salimi Street, Andarzgoo boulevard, Qeytarieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2267 8519
Email
rofeideh.hospital@uswr.ac.ir

2

Recruitment center
Name of recruitment center
Physiotherapy Clinic of School Rehabilitation of Tehran University of Medical Sciences
Full name of responsible person
Mohsen Mir
Street address
School of Rehabilitation Sciences, Tehran University of Medical Sciences, Corner of Safi Alishah Street, Shemiran Intersection, Enghelab Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
School of Rehabilitation Sciences, Tehran University of Medical Sciences, Corner of Safi Alishah Street, Shemiran Intersection, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Bahari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.179, Somayeh dormitory, Somayeh street, Tehran
City
Tehran
Province
Tehran
Postal code
1581749811
Phone
+98 13 3358 3094
Fax
Email
amir.bahari8081@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Bahari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.179, Somayeh dormitory, Somayeh street, Tehran
City
Tehran
Province
Tehran
Postal code
1581749811
Phone
+98 13 3358 3094
Fax
Email
amir.bahari8081@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Bahari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.179, Somayeh dormitory, Somayeh street, Tehran
City
Tehran
Province
Tehran
Postal code
1581749811
Phone
+98 13 3358 3094
Fax
Email
amir.bahari8081@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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